CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled

Getinge Disinfection Ab is recalling Getinge Ags, Fslc, Fsuc, RC accessory to Washer- Disinfector 88 Series, distributed nationwide in the US. The recall was initiated on 2 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI Info: 07340153700109, 07340153700116 Serial Numbers: WAA075345 WAA059630 WAA060690 WAA061680 WAA062179 WAA062399 WAA062743 WAA062967 WAA064062 WAA064977 WAA071262 WAA076435 WAA078694 WAA080011 WAA080693 WAA070436 WAA080985 WAA61348 WAA61349 WAA058540 WAA058542 WAA058543 WAA058545 WAA059053 WAA059054 WAA061345 WAA061346 WAA061347 WAA061350 WAA061351 WAA061353 WAA062020 WAA062021 WAA062022 WAA062360 WAA062361 WAA062362 WAA062363 WAA062364 WAA062365 WAA063372 WAA063373 WAA063374 WAA069593 WAA074456 WAA063375 WAA081641 WAA081811 WAA081883 WAA081884 WAA083599 WAA062023 WAA066165 WAA066166 WAA066167 WAA066168 WAA056686 WAA057547 WAA058549 WAA058550 WAA058551 WAA058552 WAA058553 WAA058554 WAA059058 WAA059059 WAA060871 WAA060886 WAA060887 WAA060888 WAA060889 WAA060926 WAA060927 WAA060928 WAA060930 WAA061284 WAA061285 WAA061286 WAA061287 WAA061288 WAA061289 WAA061290 WAA061352 WAA062027 WAA062028 WAA062072 WAA062073 WAA062366 WAA062367 WAA062368 WAA062369 WAA062370 WAA062371 WAA063376 WAA063377 WAA063378 WAA063379 WAA065341 WAA065342 WAA065343 WAA065344 WAA065345 WAA065417 WAA065418 WAA065419 WAA066318 WAA066319 WAA066320 WAA066321 WAA069587 WAA069588 WAA069589 WAA069590 WAA069591 WAA069592 WAA073494 WAA078041 WAA069584 WAA078042 WAA078051 WAA081542 WAA081571 WAA081572 WAA081573 WAA081889 WAA081890 WAA081891 WAA081892 WAA077173 WAA081956 WAA081958 WAA081959 WAA081960 WAA059509 WAA059510 WAA059785 WAA060117 WAA061108 WAA061984 WAA062306 WAA062422 WAA062524 WAA062861 WAA062926 WAA064063 WAA064980 WAA066412 WAA069490 WAA070214 WAA070368 WAA071110 WAA071421 WAA071795 WAA075696 WAA076464 WAA079990 WAA078693 WAA080987 WAA077909 WAA080988

Quantity recalled170 total products

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-1380-2018
FDA event ID: 79641
Recalling firm: Getinge Disinfection Ab, Vaxjo
Classification: Class II
Status: Terminated
Recall initiated: 2 Mar 2018
FDA classified: 16 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Mar 2018	Recall initiated by company
16 Apr 2018	Classified by FDA	+45 days
25 Apr 2018	Published in enforcement report	+9 days

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

Reason for recall

There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

Product as listed by the FDA

Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.

Where it was distributed

Worldwide Distribution - USA (nationwide) and the following countries: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, NETHERLANDS, NORWAY, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NORWAY, NEW ZELAND, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVENIA, THAILAND

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI Info: 07340153700109, 07340153700116 Serial Numbers: WAA075345 WAA059630 WAA060690 WAA061680 WAA062179 WAA062399 WAA062743 WAA062967 WAA064062 WAA064977 WAA071262 WAA076435 WAA078694 WAA080011 WAA080693 WAA070436 WAA080985 WAA61348 WAA61349 WAA058540 WAA058542 WAA058543 WAA058545 WAA059053 WAA059054 WAA061345 WAA061346 WAA061347 WAA061350 WAA061351 WAA061353 WAA062020 WAA062021 WAA062022 WAA062360 WAA062361 WAA062362 WAA062363 WAA062364 WAA062365 WAA063372 WAA063373 WAA063374 WAA069593 WAA074456 WAA063375 WAA081641 WAA081811 WAA081883 WAA081884 WAA083599 WAA062023 WAA066165 WAA066166 WAA066167 WAA066168 WAA056686 WAA057547 WAA058549 WAA058550 WAA058551 WAA058552 WAA058553 WAA058554 WAA059058 WAA059059 WAA060871 WAA060886 WAA060887 WAA060888 WAA060889 WAA060926 WAA060927 WAA060928 WAA060930 WAA061284 WAA061285 WAA061286 WAA061287 WAA061288 WAA061289 WAA061290 WAA061352 WAA062027 WAA062028 WAA062072 WAA062073 WAA062366 WAA062367 WAA062368 WAA062369 WAA062370 WAA062371 WAA063376 WAA063377 WAA063378 WAA063379 WAA065341 WAA065342 WAA065343 WAA065344 WAA065345 WAA065417 WAA065418 WAA065419 WAA066318 WAA066319 WAA066320 WAA066321 WAA069587 WAA069588 WAA069589 WAA069590 WAA069591 WAA069592 WAA073494 WAA078041 WAA069584 WAA078042 WAA078051 WAA081542 WAA081571 WAA081572 WAA081573 WAA081889 WAA081890 WAA081891 WAA081892 WAA077173 WAA081956 WAA081958 WAA081959 WAA081960 WAA059509 WAA059510 WAA059785 WAA060117 WAA061108 WAA061984 WAA062306 WAA062422 WAA062524 WAA062861 WAA062926 WAA064063 WAA064980 WAA066412 WAA069490 WAA070214 WAA070368 WAA071110 WAA071421 WAA071795 WAA075696 WAA076464 WAA079990 WAA078693 WAA080987 WAA077909 WAA080988

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

Other products in this recall event

1 other product · FDA event 79641

This product is part of a recall event; the main page for the event is Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled.

Reported	Class	Recall	Company	Reason	Where
25 Apr 2018	CLASS II	Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled	Getinge Disinfection Ab	Other	Nationwide

More recalls from Getinge Disinfection Ab

All 7

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Device	CLASS II	Getinge 88-Series Washer- Disinfector recalled	Getinge Disinfection Ab	Device Malfunction	Nationwide
14 May 2025Device	CLASS II	Washer Disinfector Aquadis recalled by Getinge Disinfection Ab	Getinge Disinfection Ab	Packaging Defects	Nationwide
14 May 2025Device	CLASS II	Washer Disinfector Aquadis recalled by Getinge Disinfection Ab	Getinge Disinfection Ab	Packaging Defects	Nationwide
25 Apr 2018Device	CLASS II	Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled	Getinge Disinfection Ab	Other	Nationwide
26 Aug 2015Device	CLASS III	Getinge 86 Series Washer/Disinfector with G1 control system recalled	Getinge Disinfection Ab	Foreign Material	12 states

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