CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Chorus Mobile Patient Lifter recalled by Arjo

Arjo is recalling Chorus Mobile Patient Lifter, distributed nationwide in the US. The recall was initiated on 29 Jun 2012 and the FDA has classified it as Class II.

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Lot, batch or date codesModel KKB5060-21US, serial numbers 050186430602, 050186430608, 050186430610, 060186430704, 080186430908, 080186430909, 090186431001, 090186431002, 090186431004, 090186431006, 090186431008, 090186431009, 090186431010, 100186431102, 100186431103, 100186431104, 100186431105, 100186431106, 100186431107, 100186431108, 100186431110, 100186431207, 100186431209, 120186815003, 120186815004, 120186815006, 120186815007, 140186815107, 140186815108, 140186815109, 140186815110, 140186820201, 140186820202, 140186820204, 140186820205, 140186820207, 140186820208, 140186820209, 140186820210, 140186820301, 140186820302, 140186820303, 140186820304, 140186820305, 140186820306, 140186820308, 140186820309, 190084658701, 190084658702, 190084658703, 190084658704, 190084658705, 190084658706, 190084658708, 190084658709, 190084658710, 200084658808, 200084658809, 200084658810, 210084711101, 210084711102, 210084711103, 210084711104, 210084711105, 210084711106, 210084711107, 230084817403, 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510085976702, 510085976704, 510085976705, 510085976707, 510085976708, 510085976710, 520086075301, 520086075302 and 520086075303; Model KKB5062-21US, serial numbers 010391015510, 020493522101, 020493522102, 020493522103, 020493522104, 020493522105, 020493522106, 030391048708, 030391048709, 040391133401, 040391133402, 040391133403, 040391133404, 040391133408, 040391133409, 050288822704, 050288822705, 050288822706, 050288822708, 050288822709, 050288822710, 050288913701, 050288913702, 050288913703, 050288913704, 050288913705, 050288913706, 050288913707, 050288913708, 050391133508, 050391133509, 050391133510, 050391146201, 050391146202, 050391146203, 050391146204, 050391146205, 050391146206, 060391240510, 060391261107, 060391261108, 060391261110, 070391292701, 080288978202, 080288978203, 080288978204, 080289003502, 080289003503, 080289003504, 080289003505, 080289003506, 080289003507, 080289003508, 080289003509, 080289003510, 090186431007, 090289044001, 090289044009, 090391328804, 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150391556805, 150391556806, 150391556807, 150391556808, 150391556809, 150391556810, 150391706601, 150391706602, 150391706603, 150391706702, 150391706703, 150391706704, 150391706705, 150391706706, 150391706707, 160186994108, 160186994109, 160186994110, 160186994201, 160186994202, 160186994203, 160186994204, 160186994205, 160186994206, 160186994207, 160186994208, 160186994209, 160186994210, 160289410007, 160289410009, 160289410010, 160289431301, 160289431302, 160391734809, 160391734810, 170187000001, 170187000002, 170187000003, 170187000004, 170187000005, 170187000006, 170187000007, 170187000008, 170187000009, 170187000010, 170187108201, 170187108202, 170187108203, 170187108204, 170187108205, 170187108206, 170187108207, 170187108208, 170187108209, 170187108210, 170187108301, 170187108302, 170187108303, 170187108304, 170187108309, 170187108310, 170289470006, 180187108401, 180187108402, 180187108403, 180187108404, 180187108405, 180187108406, 180187108407, 180187108408, 180187108409, 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210187210806, 210187210807, 210187210808, 210187210809, 210187210810, 210187210901, 210187210902, 210187210903, 210187210904, 210187210905, 210187210906, 210187210908, 210187210909, 210187210910, 210289591401, 210289591402, 210289591403, 210289591405, 210289591406, 210289591407, 210289591408, 210289591409, 210289591410, 220187211001, 220187211003, 220187211004, 220187211005, 220187211006, 220187211007, 220187211008, 220187211009, 220187211010, 220187211102, 220187214701, 220187214702, 220187214703, 220187214704, 220187214705, 220289597201, 220289597202, 220289597203, 220289597204, 220289597209, 220289597210, 230084817402, 230391993804, 230391993805, 230391993806, 230391993807, 230391993808, 230391993809, 230391993810, 230392023502, 230392023503, 230392023504, 230392023505, 230392023509, 230392023510, 240187214903, 240187214904, 240187214905, 240187214906, 240187214908, 240187214909, 240289597301, 240289597302, 240289597303, 240289597304, 240289597305, 240289597306, 240289597307, 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500188537403, 500188537404, 500188537405, 500188537406, 500188537407, 500188537408, 500188537409, 500188537410, 500290831504, 500290831505, 500290831506, 500290831507, 500290831508, 500290831509, 500290831510, 500290831601, 500290831602, 500290831603, 500290831604, 500290831605, 500290831606, 500290831607, 500290831608, 510085976604, 510188636401, 510188636402, 510188636403, 510188636404, 510188636405, 510188636406, 510188636407, 510188636408, 510188636409, 510188636410, 510188669901, 510290870101, 510290870104, 510290870105, 510290870106, 510290870107, 510290877503, 510290877504, 510290877505, 510290877506, 510290877507, 510290877508, 510393181203, 510393181204, 510393181205, 510393181206, 530290929802, 530290929803, 530290929804, 530290929805, 530290929806, 530290929807, 530290929808, 530290929809, 530290929810, 530393461707, 530393461708, 530393461709, 530393461710, 530393490701, 530393490702, 530393490703, 530393490704, 630391261106, GB060402522T, GB060402523T, GB080405381T, GB080405382T, GB080405383T, GB080405384T, GB080405795T, GB080405796T, GB080405797T, GB080405798T, GB090407337T, GB090407338T, GB090407339T, GB100534821T, GB100534822T, GB100534823T, GB120414646T, GB120414647T, GB120414648T, GB120414649T, GB120414650T, GB120414651T, GB120414652T, GB120414653T, GB120539316T, GB120539317T, GB120539318T, GB120539319T, GB120539320T, GB120539321T, GB120539322T, GB170424021T, GB170424022T, GB170424023T, GB170424028T, GB230435450T, GB230435451T, GB250439156T, GB250439157T, GB250439160T, GB260441754T, GB260441755T, GB260441756T, GB260441758T, GB260441760T, GB260443105T, GB280446487T, GB280446489T, GB280466488T, GB300448385T, GB300448387T, GB300448388T, GB300448389T, GB300448390T, GB370458261T, GB370458262T, GB370458263T, GB370458264T, GB390461960T, GB390461961T, GB390461962T, GB390461963T, GB390461964T, GB390461965T, GB390461966T, GB390461967T, GB390461968T, GB390461969T, GB400465379T, GB400465380T, GB400465381T, GB400465382T, GB400465383T, GB400465384T, GB410467120T, GB410467121T, GB410467123T, GB410467126T, GB450476122T, GB450476123T, GB450476124T, GB450476125T, GB450476126T, GB490408657T, GB490408658T, GB490408659T, GB490408660T, GB490408661T, GB490408662T, GB490408663T, GB490408664T, GB490408665T, GB490408666T and GB490408667T; and Model KKB5080-21US, serial numbers 010390930401 010390930403, 010390930404, 010390930405, 010390930406, 010390930407, 010390930408, 010390930409, 010390930410, 030391005101, 040391134707, 040391134708, 040391134709, 040391134710, 050391134801, 050391134802, 050391134803, 050391134804, 050391134805, 050391134806, 050391134807, 050391134808, 050391134809, 050391134810, 050391134901, 050391134904, 050391134905, 050391134906, 050391134907, 050391134908, 050391134909, 050391134910, 060391201101, 060391201102, 060391201103, 060391201104, 060391201106, 060391201108, 060391201109, 060391201110, 090391293401, 090391293402, 090391293403, 090391293404, 090391293405, 090391293406, 090391293407, 110391375201, 110391375202, 110391375203, 110391375204, 110391375205, 110391375206, 110391375207, 110391375208, 110391375209, 110391375210, 130289044105, 130289044106, 130289044107, 130289044108, 130289044109, 130289044110, 150289328101, 150289328102, 150289328103, 150289328104, 150289328105, 150289328107, 150289328108, 150289328109, 150289328110, 150391568501, 150391568502, 150391568503, 150391568504, 150391568505, 150391568506, 150391568507, 150391568508, 150391568509, 150391568510, 160289328209, 160289328210, 160391682201, 160391682202, 160391682203, 160391682204, 160391682205, 160391682206, 160391682207, 160391682208, 160391682209, 160391682210, 170289431501, 170289431502, 170289431503, 170289431504, 170289431505, 170289431506, 170289431508, 170289431509, 170289431510, 180391707501, 180391707502, 180391707503, 180391707504, 180391707505, 180391707506, 180391707507, 180391707508, 200289620801, 200289620802, 200289620803, 200289620804, 200289620805, 200289620806, 200289620808, 200289620809, 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240392039204, 240392039205, 240392039206, 240392039207, 240392039208, 240392039209, 240392039210, 250392039301, 250392039302, 250392039303, 250392039304, 280392230401, 280392230402, 280392230403, 280392230404, 280392230405, 280392230406, 280392230407, 280392230408, 280392230409, 280392230410, 280392230501, 280392230502, 280392230503, 280392230504, 280392230505, 280392230506, 280392230507, 280392230508, 280392230509, 280392230510, 280392230601, 280392230602, 280392230603, 280392230604, 280392230605, 280392230606, 280392230607, 280392230608, 280392230609, 280392230610, 290392230701, 290392230702, 290392230703, 290392230704, 290392230705, 290392230706, 290392230707, 290392230708, 290392230709, 290392230710, 290392230801, 290392230802, 290392230803, 290392230804, 290392230805, 290392230806, 290392230807, 290392230808, 290392230809, 290392230810, 300392275901, 300392275902, 300392275903, 300392275904, 300392275905, 300392275906, 300392275907, 300392275908, 300392275909, 300392275910, 310392300901, 310392300902, 310392300903, 310392300904, 310392300906, 310392300907, 310392300908, 310392300909, 310392300910, 310392349001, 310392349002, 310392349003, 310392349004, 310392349005, 310392349006, 310392349007, 310392349008, 310392349009, 310392349010, 320392349101, 320392349102, 320392349103, 320392349104, 320392349105, 320392349106, 320392349107, 320392349108, 320392349109, 320392349110, 330392405503, 330392405504, 330392405505, 330392405506, 330392405507, 330392405508, 330392405509, 330392405510, 340392300905, 370290170403, 370290170404, 370290170405, 370290170406, 370290170407, 370392555201, 370392555202, 370392555203, 370392555204, 370392555205, 370392555206, 370392555207, 370392555208, 370392555209, 370392555210, 390290276903, 390290276904, 390290276905, 390290276906, 390290276907, 390290276908, 390290276909, 390290276910, 400290311501, 400290311502, 400290311503, 400290311504, 400290311505, 400290311506, 400290311507, 400290311508, 400392597401, 400392597402, 400392597403, 400392597404, 400392597405, 400392597406, 400392597407, 400392597408, 400392597409, 420392720703, 420392720704, 420392720705, 420392720706, 420392720707, 420392720708, 420392720709, 420392720710, 430290354803, 430290354804, 430290354805, 430290354806, 430290354808, 430290354809, 430290354810, 430392834701, 430392834702, 430392834703, 430392834704, 430392834708, 430392834709, 430392834710, 450393044601, 450393044602, 450393044603, 450393044604, 450393044605, 450393044606, 450393044607, 450393044608, 450393044609, 450393044610, 450393044701, 450393044705, 450393044710, 460290546201, 460290546202, 460290546203, 460290546204, 460290546205, 460290546206, 460290546207, 460290546208, 460290546209, 460290546210, 460393044801, 460393044802, 460393044803, 460393044804, 460393044806, 460393044808, 460393044809, 460393044810, 470290591901, 470290591902, 470290591903, 470290591904, 470290591905,, 470290591906, 470393044901, 470393044902, 470393044904, 470393044905, 470393044906, 470393044907, 470393044908, 480290819202, 480290819203, 480290819209, 480290819210, 480290832001, 480290832002, 480290832003, 480290832004, 480290832005, 480290832007, 480290832008, 480290832009, 480290832010, 480393045001, 480393045002, 480393045003, 480393045004, 480393045005, 480393045006, 480393045007, 480393045008, 480393045009, 480393045010, 482029083204, 490290832101, 490290832103, 490290832104, 490290832105, 490290832106, 490290832107, 490290832108, 490290832109, 490290832110, 490393069503, 490393069504, 490393069505, 490393069506, 490393069507, 490393069508, 490393069509, 490393069510, 490393099501, 490393099502, 490393099503, 490393099504, 490393099505, 490393099506, 490393099507, 490393099508, 490393099509, 490393099510, 500393118801, 500393118802, 500393118803, 500393118804, 500393118805, 500393118806, 500393118807, 500393118808, 500393118809, 500393118810, 500393118901, 500393118902, 500393118903, 500393118904, 500393118905, 500393118906, 510290832202, 510290832203, 510290832204, 510290832205, 510290832206, 510290832207, 510290832208, 510290832209, 510290832210, 510290889401, 510290889402, 510290889403, 510290889404, 510290889406, 510290889407, 510290889408, 510290889409, 510290899405, GB060402327T, GB060402328T, GB060402329T, GB060402330T, GB060402331T, GB060402332T, GB060402333T, GB110537656T, GB110537657T, GB110537658T, GB110537659T, GB110537660T, GB110537661T, GB110537662T, GB110537663T, GB110537664T, GB110537665T, GB120540046T, GB120540047T, GB120540048T, GB120540049T, GB120540050T, GB120540051T, GB120540052T, GB120540053T, GB120540054T, GB120540055T, GB130417812T, GB130417813T, GB130417814T, GB130417817T, GB130417818T, GB130417819T, GB130417820T, GB130417821T, GB130541300T, GB130541301T, GB130541302T, GB130541303T, GB130541304T, GB130541305T, GB130541306T, GB130541307T, GB150420741T, GB150420742T, GB150420743T, GB150420744T, GB150420745T, GB150420746T, GB150420747T, GB150420748T, GB150420749T, GB150420750T, GB160422810T, GB160422811T, GB160422812T, GB170425490T, GB170425491T, GB170425492T, GB170425494T, GB170425495T, GB170425496T, GB170425497T, GB170425498T, GB170425499T, GB190428732T, GB190428733T, GB190428734T, GB190428735T, GB190428736T, GB190428738T, GB190428739T, GB190428740T, GB190428741T, GB220434081T, GB220434082T, GB220434083T, GB220434084T, GB220434085T, GB220434086T, GB220434087T, GB220434088T, GB220434089T, GB220434090T, GB220434599T, GB220434600T, GB220434601T, GB220434602T, GB220434603T, GB220434604T, GB220434605T, GB220434606T, GB220434607T, GB220434608T, GB230435903T, GB230435904T, GB230435905T, GB230435906T, GB230435907T, GB230435908T, GB230435909T, GB230435910T, GB230435911T, GB230435912T, GB250440700T, GB250440701T, GB250440702T, GB250440703T, GB250440704T, GB250440705T, GB250440706T, GB250440707T, GB250440708T, GB260441366T, GB260441368T, GB260441369T, GB260441370T, GB260441371T, GB260441372T, GB260441373T, GB260441374T, GB260441375T, GB270444953T, GB270444954T, GB270444955T, GB270444956T, GB270444958T, GB270444959T, GB300448820T, GB300448823T, GB300448824T, GB300448825T, GB300448826T, GB300448827T, GB300448828T, GB300448829T, GB320452306T, GB320452307T, GB320452308T, GB320452309T, GB320452310T, GB320452311T, GB320452312T, GB320452313T, GB320452314T, GB320452315T, GB340454664T, GB340454665T, GB340454666T, GB340454667T, GB340454668T, GB340454671T, GB340454672T, GB340454673T, GB390461245T, GB390461246T, GB390461247T, GB390461248T, GB390461249T, GB390461250T, GB390461251T, GB390461252T, GB390461253T, GB390461254T, GB400464772T, GB400464773T, GB400464774T, GB400464775T, GB400464776T, GB400464777T, GB400464778T, GB400464779T, GB400464780T, GB400464781T, GB410465843T, GB410465844T, GB410465845T, GB410465846T, GB410465847T, GB410465848T, GB410465849T, GB410465850T, GB420468355T, GB420468356T, GB420468357T, GB420468358T, GB420468359T, GB420468360T, GB420468361T, GB420468362T, GB420468363T, GB420468364T, GB420468902T, GB420468903T, GB420468904T, GB420468905T, GB420468906T, GB420468907T, GB420468908T, GB420468909T, GB420468910T, GB420468911T, GB470479419T, GB470479420T, GB470479421T, GB470479422T, GB470479423T, GB470479425T, GB470479426T, GB470479427T, GB480406353T, GB480406354T, GB480406355T, GB480406356T, GB480406357T, GB480406358T, GB480406359T, GB480406360T, GB480406361T, GB480406362T, GB480406744T, GB480406745T, GB480406746T, GB480406747T, GB480406748T, GB480406749T, GB480406750T, GB480406751T, GB480406752T, GB480406753T, GB480407131T, GB480407132T, GB480407133T, GB480407134T, GB480407135T, GB480407136T, GB480407137T, GB480407138T, GB480407139T, GB480407140T, GB480407350T, GB480407351T, GB480407352T, GB480407353T, GB480407354T, GB480407355T, GB480407356T, GB480407357T, GB480407358T, GB480407359T, GB490408079T, GB490408080T, GB490408081T, GB490408082T, GB490408083T, GB490408084T, GB490408085T, GB490408086T, GB490408087T, GB490408088T, GB520413764T, GB520413765T, GB520413766T, GB520413767T, GB520413768T, GB520413769T, GB520413770T, GB520413771T, GB520413772T, GB520413773T, GB520414012T, GB520414013T, GB520414014T, GB520414015T, GB520414016T, GB520414017T, GB520414018T, GB520414019T and GB520414020T,

Quantity recalled1,989 units in the U.S., 1,626 units in the rest of the world

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1948-2012
FDA event ID: 62116
Recalling firm: Arjo, Addison, IL
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2012
FDA classified: 6 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Wheelchairs, Beds & Lifts

Timeline

29 Jun 2012	Recall initiated by company
6 Jul 2012	Classified by FDA	+7 days
18 Jul 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey

Nationwide

Questions about this recall

Is Chorus Mobile Patient Lifter recalled?

Yes. Arjo recalled Chorus Mobile Patient Lifter on 29 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1948-2012.

Why was it recalled?

ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.

Which lots are affected?

Model KKB5060-21US, serial numbers 050186430602, 050186430608, 050186430610, 060186430704, 080186430908, 080186430909, 090186431001, 090186431002, 090186431004, 090186431006, 090186431008, 090186431009, 090186431010, 100186431102, 100186431103, 100186431104, 100186431105, 100186431106, 100186431107, 100186431108, 100186431110, 100186431207, 100186431209, 120186815003, 120186815004, 120186815006, 120186815007, 140186815107, 140186815108, 140186815109, 140186815110, 140186820201, 140186820202, 140186820204, 140186820205, 140186820207, 140186820208, 140186820209, 140186820210, 140186820301, 140186820302, 140186820303, 140186820304, 140186820305, 140186820306, 140186820308, 140186820309, 190084658701, 190084658702, 190084658703, 190084658704, 190084658705, 190084658706, 190084658708, 190084658709, 190084658710, 200084658808, 200084658809, 200084658810, 210084711101, 210084711102, 210084711103, 210084711104, 210084711105, 210084711106, 210084711107, 230084817403, 230084817404, 230084817405, 230084817406, 230084817407, 230084817408, 230084817409, 230084817410, 230084817501, 230084817502, 230084817503, 230084817504, 230084817505, 230084817506, 230084817507, 230084817508, 230084817509, 240084817601, 240084817602, 240084817603, 240084817605, 240084817606, 240084817607, 240084817608, 240084817609, 240084817610, 240084883501, 240084883502, 240084883503, 240084883504, 240084883505, 240084883506, 240084883507, 240084883508, 240084883509, 240084883510, 250084883601, 250084883602, 250084883603, 250084883604, 250084883605, 250084883606, 250084883607, 250084883608, 250084883609, 260084883706, 260084883707, 260084883708, 260084883709, 260084883710, 280084890507, 280084890508, 280084890509, 290085094401, 290085094402, 290085094403, 290085094404, 290085094405, 290085094406, 290085094407, 290085094408, 290085094409, 290085094410, 290085097401, 290085097403, 290085097404, 290085097405, 290085097406, 290085097407, 290085097408, 290085097409, 290085097410, 300085097501, 300085097503, 390085458901, 390085458903, 390085458904, 390085458905, 390085458907, 390085458909, 390085458910, 390085532401, 390085532402, 390085532403, 390085532405, 390085532406, 390085532407, 390085532408, 390085532409, 390085532410, 390085532501, 390085532502, 390085532503, 390085532504, 390085532505, 390085532506, 390085532507, 390085532508, 390085532509, 390085532510, 410085535901, 410085535902, 410085535903, 410085535904, 410085535905, 410085535906, 410085535907, 410085535908, 410085535909, 410085535910, 420085536002, 420085536004, 420085536005, 420085536006, 420085536007, 420085536008, 420085536009, 420085536010, 430085536101, 430085536102, 430085536103, 430085536104, 430085536105, 470085863205, 470085863206, 470085863207, 500085888204, 500085888205, 500085888208, 500085888209, 500085888210, 500085908001, 500085908002, 500085908003, 500085908004, 500085908005, 510085961909, 510085976601, 510085976602, 510085976603, 510085976605, 510085976606, 510085976608, 510085976702, 510085976704, 510085976705, 510085976707, 510085976708, 510085976710, 520086075301, 520086075302 and 520086075303; Model KKB5062-21US, serial numbers 010391015510, 020493522101, 020493522102, 020493522103, 020493522104, 020493522105, 020493522106, 030391048708, 030391048709, 040391133401, 040391133402, 040391133403, 040391133404, 040391133408, 040391133409, 050288822704, 050288822705, 050288822706, 050288822708, 050288822709, 050288822710, 050288913701, 050288913702, 050288913703, 050288913704, 050288913705, 050288913706, 050288913707, 050288913708, 050391133508, 050391133509, 050391133510, 050391146201, 050391146202, 050391146203, 050391146204, 050391146205, 050391146206, 060391240510, 060391261107, 060391261108, 060391261110, 070391292701, 080288978202, 080288978203, 080288978204, 080289003502, 080289003503, 080289003504, 080289003505, 080289003506, 080289003507, 080289003508, 080289003509, 080289003510, 090186431007, 090289044001, 090289044009, 090391328804, 090391328805, 090391328806, 090391328807, 090391328808, 100186431101, 100289064101, 100289064103, 100289064104, 100289064106, 100289064107, 100289064108, 100289064109, 100289064110, 110289152001, 110289152002, 110289152003, 110289152008, 110289152009, 110289152010, 110289188501, 110289188502, 110289188504, 110289188505, 110289188506, 110289188507, 110289188508, 110289188509, 110289188510, 110391404204, 110391404206, 110391404207, 110391404208, 110391404209, 110391458406, 110391458407, 110391458408, 110391458409, 110391458410, 120186815008, 120186815009, 120186815010, 120289227201, 130289251810, 130391473301, 130391473310, 140186815101, 140186815102, 140186815104, 140186815105, 140186815106, 140186820307, 150186993502, 150186993503, 150186993504, 150186993505, 150186993506, 150186993507, 150186993509, 150186993510, 150186994001, 150186994002, 150186994003, 150186994004, 150186994005, 150186994006, 150186994007, 150289304601, 150289304602, 150289304610, 150391556801, 150391556804, 150391556805, 150391556806, 150391556807, 150391556808, 150391556809, 150391556810, 150391706601, 150391706602, 150391706603, 150391706702, 150391706703, 150391706704, 150391706705, 150391706706, 150391706707, 160186994108, 160186994109, 160186994110, 160186994201, 160186994202, 160186994203, 160186994204, 160186994205, 160186994206, 160186994207, 160186994208, 160186994209, 160186994210, 160289410007, 160289410009, 160289410010, 160289431301, 160289431302, 160391734809, 160391734810, 170187000001, 170187000002, 170187000003, 170187000004, 170187000005, 170187000006, 170187000007, 170187000008, 170187000009, 170187000010, 170187108201, 170187108202, 170187108203, 170187108204, 170187108205, 170187108206, 170187108207, 170187108208, 170187108209, 170187108210, 170187108301, 170187108302, 170187108303, 170187108304, 170187108309, 170187108310, 170289470006, 180187108401, 180187108402, 180187108403, 180187108404, 180187108405, 180187108406, 180187108407, 180187108408, 180187108409, 180187108410, 180187108501, 180187108502, 180187108503, 180187108504, 180187108505, 180187108506, 180187108507, 180187108508, 180187108509, 180187108510, 180187108601, 180187108602, 180187108603, 180187108604, 180187108605, 180187108606, 180187108607, 180187108608, 180187108609, 180187108610, 180187110401, 180187110402, 180187110403, 180187110404, 180187110405, 180187110406, 180187110407, 180187110408, 180187110410, 180289541404, 180289541405, 180289541406, 180289541407, 180289541408, 180289541409, 180289541410, 180391776801, 180391776802, 180391776803, 180391776804, 180391776805, 190391790510, 190391812701, 190391812703, 190391812704, 190391812707, 190391812708, 200187210601, 200187210602, 200187210605, 200187210606, 200187210607, 200187210608, 200187210609, 200187210610, 200187210701, 200187210702, 200187210703, 200187210704, 200187210705, 200187210706, 200187210707, 200187210708, 200187210709, 200187210710, 210187210801, 210187210802, 210187210803, 210187210804, 210187210805, 210187210806, 210187210807, 210187210808, 210187210809, 210187210810, 210187210901, 210187210902, 210187210903, 210187210904, 210187210905, 210187210906, 210187210908, 210187210909, 210187210910, 210289591401, 210289591402, 210289591403, 210289591405, 210289591406, 210289591407, 210289591408, 210289591409, 210289591410, 220187211001, 220187211003, 220187211004, 220187211005, 220187211006, 220187211007, 220187211008, 220187211009, 220187211010, 220187211102, 220187214701, 220187214702, 220187214703, 220187214704, 220187214705, 220289597201, 220289597202, 220289597203, 220289597204, 220289597209, 220289597210, 230084817402, 230391993804, 230391993805, 230391993806, 230391993807, 230391993808, 230391993809, 230391993810, 230392023502, 230392023503, 230392023504, 230392023505, 230392023509, 230392023510, 240187214903, 240187214904, 240187214905, 240187214906, 240187214908, 240187214909, 240289597301, 240289597302, 240289597303, 240289597304, 240289597305, 240289597306, 240289597307, 240289597308, 240289597309, 240289597310, 250187225801, 250187225802, 250187225803, 250187225804, 250187225805, 250187225806, 250187225807, 250187225810, 250187396201, 250289597401, 250289597402, 250289597403, 250289597404, 250289597405, 250289597406, 250289597407, 250289597408, 250289597409, 250289597410, 250289597504, 250289597505, 250289597506, 250289597507, 250289597508, 250289597509, 250289597510, 250392023601, 250392023602, 250392023603, 250392023604, 250392112607, 250392112608, 250392112610, 260187243301, 260187243302, 260187243303, 260187243304, 260187243307, 260187243308, 260187243309, 260187243310, 260187313001, 260187313002, 260187313003, 260187313004, 260187313005, 260187313006, 260187313007, 260187313008, 260187313009, 260187313010, 260187313101, 260187313102, 260187313103, 260187313108, 260187313109, 260187313110, 260289812301, 260289812302, 260289812303, 260289812304, 260289812305, 260289812306, 260289812307, 260289812308, 260289812309, 260289812310, 260289828201, 260289828202, 260289828203, 260289828204, 260289828205, 260289828206, 260289828207, 260289828208, 260289828209, 260289828210, 260289828301, 260289828302, 260289828303, 260391256509, 260392156501, 260392156502, 260392156503, 260392156504, 260392156505, 260392156506, 260392156507, 260392156508, 260392156510, 260392184701, 260392184702, 260392184703, 260392184704, 260392184705, 260392184706, 260392184707, 260392184708, 260392184709, 260392184710, 260392184801, 260392184802, 260392184803, 260392184804, 260392184805, 270187366502, 270187366503, 270187366504, 270187366505, 270187366507, 270187366508, 270187366510, 270392229509, 270392229510, 280187395901, 280187395902, 280187395903, 280187395904, 280187395905, 280187395906, 280187395907, 280187395909, 280187395910, 280187533601, 280187533602, 280187533603, 280187533604, 280187533605, 280187533606, 280187533608, 280187533609, 280187533610, 280289874902, 280289874903, 280289874904, 280289874905, 280289874906, 280289874907, 280289874908, 280289874909, 280289874910, 280392229601, 280392229602, 280392229603, 280392229604, 280392229605, 280392229606, 280392229607, 280787395906, 290187565601, 290187565602, 290187565603, 290187565604, 290187565605, 290187565607, 290187565609, 290187565610, 290289947701, 290289947702, 290289947703, 290289947704, 290289947705, 290289947706, 290289947707, 290289947708, 290289947709, 290289947710, 290289981101, 290289981102, 290289981103, 290289981104, 290289981105, 290289981106, 290289981107, 290289981108, 290289981109, 290289981110, 290289987201, 290289987206, 290289987210, 300187624701, 300187624702, 300187624703, 300187624704, 300187624705, 310187669705, 310187669710, 310187699707, 310289996301, 310289996302, 310289996303, 310289996304, 310289996305, 310289996306, 310289996307, 310289996308, 310289996309, 310289996310, 320290038301, 320290038302, 320290038303, 320290038304, 320290038305, 320290062907, 320290062908, 320290062909, 320290062910, 320392387304, 320392387305, 320392387308, 320392387309, 320392387310, 330187717002, 330187717003, 330187717004, 330187717005, 330187717006, 330187717008, 330187717009, 330187717010, 330187717101, 330187717102, 330187717104, 330187717106, 330187717107, 330187717108, 340187757707, 340187757708, 340187757709, 340187757710, 340290156201, 340290156202, 340290156203, 340290156204, 340290156207, 340290156208, 340290156209, 340290156210, 340290156301, 340290156302, 340290156303, 340290156304, 340290156305, 340290156306, 340290156307, 340290156308, 340290156309, 340290156310, 340290156401, 340290156402, 340290156403, 340290156404, 340290156405, 340290156406, 340290156407, 340290156408, 340290156410, 360187811002, 360187811003, 360187811004, 360187811005, 360187811006, 360187811007, 360392506701, 360392548203, 360392548204, 360392548205, 360392548206, 360392548207, 360392548208, 380188054805, 380188054806, 380188054807, 380188054808, 380188054809, 380188054810, 380188118101, 380188118102, 380188118104, 380188118105, 380188118106, 380188118109, 380290193001, 380290193002, 380290193003, 380290193004, 380290193005, 380290193006, 380290193007, 380290193008, 380290193009, 380290276503, 380290276504, 380290276505, 380290276506, 380290276507, 380290276508, 380290276509, 380290276510, 390085532404, 390188118202, 390188118203, 390188118204, 390188118205, 390188118206, 390188118207, 390188118208, 390188118209, 390188118210, 390188118302, 390188118303, 390188118307, 390188118308, 390188118309, 390188118310, 390188138801, 390188138802, 390188138803, 390188138804, 390188138805, 390392550403, 390392550404, 390392550405, 390392550406, 390392550407, 390392550408, 390392550409, 400290311101, 400290311102, 400392720106, 400392720107, 400392720108, 400392720109, 400392720110, 420188254502, 420188254503, 420188254506, 420188254509, 420188254510, 420290416604, 420290416605, 420290416606, 420290416607, 420290416608, 420290416609, 420290416610, 420392743201, 420392743202, 420392743203, 420392743208, 420392743209, 420392743210, 430188323302, 430188323303, 430188323304, 430188323305, 430188323306, 430188323307, 430188323308, 430188323309, 430188323310, 430188323401, 430188323402, 430188323403, 430188323404, 430188323501, 430188323502, 430188323503, 430188323504, 430188323507, 430188323508, 430188323509, 430188323510, 430392874901, 430392874902, 430392874903, 440290459401, 440290459402, 440290459403, 440290459404, 440290459405, 440290459406, 440290459407, 440290459408, 440290459409, 440290459504, 440290459506, 440290459507, 440290459508, 440290459509, 440290459510, 440392875001, 440392875002, 440392875003, 440392875004, 440392875005, 440392875006, 440392875007, 440392875008, 440392875009, 440392875010, 450290490201, 450290490202, 450290490203, 450290490204, 450290490205, 450290490206, 450290490207, 450290490208, 450290490209, 450290490210, 450290545601, 450290545602, 450290545603, 450290545607, 450290545608, 450290545609, 450290545610, 460188423001, 460188423002, 460188423003, 460188423004, 460188423005, 460188423006, 460188423007, 460188423009, 460188423010, 460188423101, 460188423102, 460188423103, 460188423104, 460188423105, 460188423106, 460188423107, 460188423108, 460188423109, 460188423110, 460188427901, 460188427902, 460188427903, 460188427904, 460188427905, 460188427906, 460188427907, 460188427908, 460188427909, 460188428003, 460188428004, 460188428005, 460188428006, 460188428007, 460188428008, 460188428009, 460188428010, 460290576901, 460290576902, 460290576906, 460290576907, 460290576908, 460290576909, 460290576910, 460393044301, 460393044302, 470188446201, 470188446202, 470188446203, 470188446204, 470188446205, 470290643201, 470290643202, 470290643203, 470290643204, 470290643205, 470290643206, 470290643207, 470290643208, 470290643209, 470290643210, 480290643301, 480290643302, 480290643303, 480290643304, 480290643305, 480393053806, 480393053807, 480393053808, 480393069401, 480393069402, 480393069403, 480393069404, 480393069405, 480393069409, 480393069410, 500188537402, 500188537403, 500188537404, 500188537405, 500188537406, 500188537407, 500188537408, 500188537409, 500188537410, 500290831504, 500290831505, 500290831506, 500290831507, 500290831508, 500290831509, 500290831510, 500290831601, 500290831602, 500290831603, 500290831604, 500290831605, 500290831606, 500290831607, 500290831608, 510085976604, 510188636401, 510188636402, 510188636403, 510188636404, 510188636405, 510188636406, 510188636407, 510188636408, 510188636409, 510188636410, 510188669901, 510290870101, 510290870104, 510290870105, 510290870106, 510290870107, 510290877503, 510290877504, 510290877505, 510290877506, 510290877507, 510290877508, 510393181203, 510393181204, 510393181205, 510393181206, 530290929802, 530290929803, 530290929804, 530290929805, 530290929806, 530290929807, 530290929808, 530290929809, 530290929810, 530393461707, 530393461708, 530393461709, 530393461710, 530393490701, 530393490702, 530393490703, 530393490704, 630391261106, GB060402522T, GB060402523T, GB080405381T, GB080405382T, GB080405383T, GB080405384T, GB080405795T, GB080405796T, GB080405797T, GB080405798T, GB090407337T, GB090407338T, GB090407339T, GB100534821T, GB100534822T, GB100534823T, GB120414646T, GB120414647T, GB120414648T, GB120414649T, GB120414650T, GB120414651T, GB120414652T, GB120414653T, GB120539316T, GB120539317T, GB120539318T, GB120539319T, GB120539320T, GB120539321T, GB120539322T, GB170424021T, GB170424022T, GB170424023T, GB170424028T, GB230435450T, GB230435451T, GB250439156T, GB250439157T, GB250439160T, GB260441754T, GB260441755T, GB260441756T, GB260441758T, GB260441760T, GB260443105T, GB280446487T, GB280446489T, GB280466488T, GB300448385T, GB300448387T, GB300448388T, GB300448389T, GB300448390T, GB370458261T, GB370458262T, GB370458263T, GB370458264T, GB390461960T, GB390461961T, GB390461962T, GB390461963T, GB390461964T, GB390461965T, GB390461966T, GB390461967T, GB390461968T, GB390461969T, GB400465379T, GB400465380T, GB400465381T, GB400465382T, GB400465383T, GB400465384T, GB410467120T, GB410467121T, GB410467123T, GB410467126T, GB450476122T, GB450476123T, GB450476124T, GB450476125T, GB450476126T, GB490408657T, GB490408658T, GB490408659T, GB490408660T, GB490408661T, GB490408662T, GB490408663T, GB490408664T, GB490408665T, GB490408666T and GB490408667T; and Model KKB5080-21US, serial numbers 010390930401 010390930403, 010390930404, 010390930405, 010390930406, 010390930407, 010390930408, 010390930409, 010390930410, 030391005101, 040391134707, 040391134708, 040391134709, 040391134710, 050391134801, 050391134802, 050391134803, 050391134804, 050391134805, 050391134806, 050391134807, 050391134808, 050391134809, 050391134810, 050391134901, 050391134904, 050391134905, 050391134906, 050391134907, 050391134908, 050391134909, 050391134910, 060391201101, 060391201102, 060391201103, 060391201104, 060391201106, 060391201108, 060391201109, 060391201110, 090391293401, 090391293402, 090391293403, 090391293404, 090391293405, 090391293406, 090391293407, 110391375201, 110391375202, 110391375203, 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GB520414012T, GB520414013T, GB520414014T, GB520414015T, GB520414016T, GB520414017T, GB520414018T, GB520414019T and GB520414020T,

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Arjo

All 9

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017Device	CLASS II	ArjoHuntleigh Flowtron ACS900, medical pump recalled	Arjo	Device Malfunction	Nationwide
20 Apr 2016Device	CLASS II	The Concerto Basic Shower Trolley is intended recalled by Arjo	Arjo	Other	36 states
22 Oct 2014Device	CLASS II	Medium 2-Hooks Spreader Bar for use with Loop Slings recalled by Arjo	Arjo	Other	5 states
14 Aug 2013Device	CLASS II	Enterprise 9000 Bed recalled by Arjo	Arjo	Device Malfunction	Nationwide
14 Aug 2013Device	CLASS II	Enterprise 8000 Bed recalled by Arjo	Arjo	Other	Nationwide

Other Wheelchairs, Beds & Lifts recalls

All 172

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products	Pride Mobility Products	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Quantum Rehab Q6 Edge 0 (ilevel) recalled by Pride Mobility Products	Pride Mobility Products	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Quantum Rehab Q6 Edge recalled by Pride Mobility Products	Pride Mobility Products	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Quantum rehab Q6 Edge recalled by Pride Mobility Products	Pride Mobility Products	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	Quantum Rehab Q6 Edge recalled by Pride Mobility Products	Pride Mobility Products	Device Malfunction	Nationwide