CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Medline procedure kits labeled as: Ablation Pack, Pack Number recalled

Medline Industries LP - Northfield is recalling Medline procedure kits labeled as: Ablation Pack, Pack Number, distributed nationwide in the US. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Pack Number DYNJ40629B: UDI/DI 10888277778696 (each) 40888277778697 (case), Lot number 21EME542A; 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case), Lot number 21LBH976A; 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case), Lot number 22GBX458A; 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case), Lot number 23LMF912A; 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case), Lot number 22GBI566A; 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case), Lot number 23HMC076A; 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case), Lot number 23EMC403A; 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case), Lot number 23HMC803A; 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case), Lot number 21JMH176A; 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case), Lot number 22GBH503A; 11) Pack Number DYNJ60998: UDI/DI 10193489546149 (each) 40193489546140 (case), Lot number 21GMD619A; 12) Pack Number DYNJ51663B: UDI/DI 10889942965250 (each) 40889942965251 (case), Lot number 22CMG200A; 13) Pack Number DYNJ59943C: UDI/DI 10195327042547 (each) 40195327042548 (case), Lot number 21LBI099A; 14) Pack Number DYNJ904625D: UDI/DI 10193489419863 (each) 40193489419864 (case), Lot number 22IBD797Z; 15) Pack Number DYNJ902780D: UDI/DI 10193489221329 (each) 40193489221320 (case), Lot number 23GBO958Z; 16) Pack Number DYNJ83414: UDI/DI 10195327264949 (each) 40195327264940 (case), Lot number 23FMD507A; 17) Pack Number DYNJ51502A: UDI/DI 10193489686326 (each) 40193489686327 (case), Lot number 21BBD357A; 18) Pack Number DYNJ16657G: UDI/DI 10193489362619 (each) 40193489362610 (case), Lot number 21GMD931A; 19) Pack Number DYNJ37370B: UDI/DI 10889942223633 (each) 40889942223634 (case), Lot number 21IMF238A; 20) Pack Number DYNJ26209N: UDI/DI 10193489483161 (each) 40193489483162 (case), Lot number 22CMF620A; 21) Pack Number DYNJ04581P: UDI/DI 10193489555479 (each) 40193489555470 (case), Lot number 23DMB984A; 22) Pack Number DYNJ67745A: UDI/DI 10195327409401 (each) 40195327409402 (case), Lot number 24ABA563Z; 23) Pack Number DYNJ09820J: UDI/DI 10888277840928 (each) 40888277840929 (case), Lot number 21BBG608A; 24) Pack Number DYNJ48884C: UDI/DI 10193489476651 (each) 40193489476652 (case), Lot number 21LMF921A; 25) Pack Number DYNJ57709B: UDI/DI 10193489424065 (each) 40193489424066 (case), Lot number 23JBR204A; 26) Pack Number DYNJ80172B: UDI/DI 10195327359188 (each) 40195327359189 (case), Lot number 23FBM928A; 27) Pack Number DYNJ46550F: UDI/DI 10193489338812 (each) 40193489338813 (case), Lot number 20LKB332A; 28) Pack Number DYNJ63472: UDI/DI 10193489745597 (each) 40193489745598 (case), Lot number 23EBD908A; 29) Pack Number DYNJ902455I: UDI/DI 10193489309584 (each) 40193489309585 (case), Lot number 20HBJ365Z; 30) Pack Number DYNJ61652: UDI/DI 10193489586855 (each) 40193489586856 (case), Lot number 20JKA923A; 31) Pack Number DYNJHS0235C: UDI/DI 10889942635245 (each) 40889942635246 (case), Lot number 21JMA297A; 32) Pack Number DYNJ21605J: UDI/DI 10195327108700 (each) 40195327108701 (case), Lot number 22BMG822Z; 33) Pack Number DYNJ52642F: UDI/DI 10195327441302 (each) 40195327441303 (case), Lot number 23HMB247A; 34) Pack Number DYNJ59313B: UDI/DI 10195327248338 (each) 40195327248339 (case), Lot number 23LME174A; 35) Pack Number DYNJ902039F: UDI/DI 10195327390631 (each) 40195327390632 (case), Lot number 23GBO615Z; 36) Pack Number DYNJ83049: UDI/DI 10195327234300 (each) 40195327234301 (case), Lot number 23AMI041A; 37) Pack Number DYNJ66821A: UDI/DI 10193489974928 (each) 40193489974929 (case), Lot number 23IBJ792A; 38) Pack Number DYNJ16629D: UDI/DI 10889942870585 (each) 40889942870586 (case), Lot number 20HKB315A; 39) Pack Number DYNJ67695A: UDI/DI 10195327512200 (each) 40195327512201 (case), Lot number 23LMG985A; 40) Pack Number DYNJS3032: UDI/DI 10884389408407 (each) 40884389408408 (case), Lot number 23BBO868Z; 41) Pack Number DYNJ44675K: UDI/DI 10195327127480 (each) 40195327127481 (case), Lot number 23BDA249A; 42) Pack Number DYNJ46190G: UDI/DI 10195327213855 (each) 40195327213856 (case), Lot number 23EMD906A; 43) Pack Number DYNJ68885A: UDI/DI 10195327187453 (each) 40195327187454 (case), Lot number 23FBO338A; 44) Pack Number DYNJ45578B: UDI/DI 10195327059187 (each) 40195327059188 (case), Lot number 23GBD205A; 45) Pack Number DYNJ43784A: UDI/DI 10889942903047 (each) 40889942903048 (case), Lot number 23HME180A; 46) Pack Number DYNJ04690Y: UDI/DI 10195327381752 (each) 40195327381753 (case), Lot number 23DME413A; 47) Pack Number DYNJQ0629F: UDI/DI 10889942565559 (each) 40889942565550 (case), Lot number 21FBP134A; 48) Pack Number DYNJ69256: UDI/DI 10193489918151 (each) 40193489918152 (case), Lot number 21JMI098A; 49) Pack Number DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374 (case), Lot number 23LMF829A; 50) Pack Number DYNJ19521P: UDI/DI 10193489941197 (each) 40193489941198 (case), Lot number 21IMD905A; 51) Pack Number DYNJ49947G: UDI/DI 10193489474152 (each) 40193489474153 (case), Lot number 21GMD742A; 52) Pack Number DYNJ51573C: UDI/DI 10195327561222 (each) 40195327561223 (case), Lot number 23LMG544A; 53) Pack Number DYNJ51575B: UDI/DI 10195327132248 (each) 40195327132249 (case), Lot number 22JMB950A; 54) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD323A; 55) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD611A; 56) Pack Number DYNJ55538B: UDI/DI 10193489574630 (each) 40193489574631 (case), Lot number 21BBG139A; 57) Pack Number DYNJ44022B: UDI/DI 10193489429329 (each) 40193489429320 (case), Lot number 22DBR220Z; 58) Pack Number DYNJ47704G: UDI/DI 10195327380724 (each) 40195327380725 (case), Lot number 23FMF488A; 59) Pack Number DYNJ82688: UDI/DI 10195327202903 (each) 40195327202904 (case), Lot number 23LMG154A; 60) Pack Number DYNJ82436A: UDI/DI 10195327362607 (each) 40195327362608 (case), Lot number 23EMD052A; 61) Pack Number DYNJ83622: UDI/DI 10195327285753 (each) 40195327285754 (case), Lot number 23FBN812A; 62) Pack Number DYNJ0785763L: UDI/DI 10193489351095 (each) 40193489351096 (case), Lot number 21LMF965A; 63) Pack Number DYNJ49994I: UDI/DI 10195327065775 (each) 40195327065776 (case), Lot number 21LMF123A; 64) Pack Number DYNJ66233A: UDI/DI 10195327176600 (each) 40195327176601 (case), Lot number 23LME717A; 65) Pack Number DYNJ55378C: UDI/DI 10193489443776 (each) 40193489443777 (case), Lot number 22GBJ071A; 66) Pack Number DYNJ69574A: UDI/DI 10195327242473 (each) 40195327242474 (case), Lot number 22JBI116Z; 67) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22CMA803A; 68) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA579A; 69) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA581A

Quantity recalled11,774 units

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-1441-2025
FDA event ID: 96374
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2025
FDA classified: 25 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

11 Feb 2025	Recall initiated by company
25 Mar 2025	Classified by FDA	+42 days
2 Apr 2025	Published in enforcement report	+8 days

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

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

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

Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ80438; 6) DONOR FREE FLAP PACK-LF, Pack Number DYNJ0426069N; 7) ENT PACK, Pack Number DYNJ50915B; 8) GENERAL LAPAROSCOPY PACK, Pack Number DYNJ63363G; 9) GENERAL LAPAROSCOPY PACK-LF, Pack Number DYNJ0415393J; 10) GENERAL LAPAROSCOPY PLUS, Pack Number DYNJ66729; 11) GERMANTOWN GENERAL LAP CHO, Pack Number DYNJ60998; 12) KOS LAPAROSCOPY PACK-LF, Pack Number DYNJ51663B; 13) LAP CHOLE, Pack Number DYNJ59943C; 14) LAP CHOLE, Pack Number DYNJ904625D; 15) LAP CHOLE, Pack Number DYNJ902780D; 16) LAP CHOLE I-LF, Pack Number DYNJ83414; 17) LAP CHOLE PACK, Pack Number DYNJ51502A; 18) LAP CHOLE PACK, Pack Number DYNJ16657G; 19) LAP CHOLE PACK, Pack Number DYNJ37370B; 20) LAP CHOLE PACK, Pack Number DYNJ26209N; 21) LAP CHOLE PACK, Pack Number DYNJ04581P; 22) LAP CHOLE PACK, Pack Number DYNJ67745A; 23) LAP CHOLE PACK-LF, Pack Number DYNJ09820J; 24) LAP CHOLE TRAY-LF, Pack Number DYNJ48884C; 25) LAPAROSCOPIC, Pack Number DYNJ57709B; 26) LAPAROSCOPIC COLORECTAL PACK, Pack Number DYNJ80172B; 27) LAPAROSCOPIC PACK, Pack Number DYNJ46550F; 28) LAPAROSCOPIC PACK, Pack Number DYNJ63472; 29) LAPAROSCOPY ESC, Pack Number DYNJ902455I; 30) LAPAROSCOPY PACK, Pack Number DYNJ61652; 31) LAPAROSCOPY PACK, Pack Number DYNJHS0235C; 32) LAPAROSCOPY PACK, Pack Number DYNJ21605J; 33) LAPAROTOMY PACK, Pack Number DYNJ52642F; 34) LAPAROTOMY PACK, Pack Number DYNJ59313B; 35) LEX CYSTO-TUR, Pack Number DYNJ902039F; 36) LUKENS MAJOR PACK, Pack Number DYNJ83049; 37) MAIN & ODS CYSTO PACK, Pack Number DYNJ66821A; 38) MAJOR BASIN PACK, Pack Number DYNJ16629D; 39) MAJOR LAPAROTOMY PACK, Pack Number DYNJ67695A; 40) MAJOR SINGLE BASIN W/GOWNS, Pack Number DYNJS3032; 41) MINOR ABDOMINAL, Pack Number DYNJ44675K; 42) MINOR PACK, Pack Number DYNJ46190G; 43) MINOR PACK, Pack Number DYNJ68885A; 44) MINOR PACK, Pack Number DYNJ45578B; 45) MINOR PACK, Pack Number DYNJ43784A; 46) MINOR PACK-LF, Pack Number DYNJ04690Y; 47) MINOR PROCEDURE PACK, Pack Number DYNJQ0629F; 48) MINOR PROCEDURE PACK, Pack Number DYNJ69256; 49) MINOR UROLOGY PACK, Pack Number DYNJ49310F; 50) MLD PACK, Pack Number DYNJ19521P; 51) MP LAP CHOLE, Pack Number DYNJ49947G; 52) NHCH GENERAL PACK, Pack Number DYNJ51573C; 53) NHCH LAPAROSCOPY PACK, Pack Number DYNJ51575B; 54) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 55) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 56) PED LAPAROTOMY PACK, Pack Number DYNJ55538B; 57) PK, URO-CYSTO, Pack Number DYNJ44022B; 58) RF LAP CHOLEPACK (LCLUI)642-LF, Pack Number DYNJ47704G; 59) ROBOT PROSTATECTOMY PACK, Pack Number DYNJ82688; 60) ROBOTIC PACK, Pack Number DYNJ82436A; 61) ROBOTICS PACK, Pack Number DYNJ83622; 62) RR-LAP NEPHRECTOMY PACK-LF, Pack Number DYNJ0785763L; 63) SC LAPAROSCOPY, Pack Number DYNJ49994I; 64) SCRIPPS HEALTH LAPAROSCOPY PK, Pack Number DYNJ66233A; 65) SMALL PROCEDURE PACK, Pack Number DYNJ55378C; 66) TUR / CYSTO PACK, Pack Number DYNJ69574A; 67) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 68) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 69) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

1) Pack Number DYNJ40629B: UDI/DI 10888277778696 (each) 40888277778697 (case), Lot number 21EME542A; 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case), Lot number 21LBH976A; 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case), Lot number 22GBX458A; 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case), Lot number 23LMF912A; 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case), Lot number 22GBI566A; 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case), Lot number 23HMC076A; 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case), Lot number 23EMC403A; 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case), Lot number 23HMC803A; 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case), Lot number 21JMH176A; 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case), Lot number 22GBH503A; 11) Pack Number DYNJ60998: UDI/DI 10193489546149 (each) 40193489546140 (case), Lot number 21GMD619A; 12) Pack Number DYNJ51663B: UDI/DI 10889942965250 (each) 40889942965251 (case), Lot number 22CMG200A; 13) Pack Number DYNJ59943C: UDI/DI 10195327042547 (each) 40195327042548 (case), Lot number 21LBI099A; 14) Pack Number DYNJ904625D: UDI/DI 10193489419863 (each) 40193489419864 (case), Lot number 22IBD797Z; 15) Pack Number DYNJ902780D: UDI/DI 10193489221329 (each) 40193489221320 (case), Lot number 23GBO958Z; 16) Pack Number DYNJ83414: UDI/DI 10195327264949 (each) 40195327264940 (case), Lot number 23FMD507A; 17) Pack Number DYNJ51502A: UDI/DI 10193489686326 (each) 40193489686327 (case), Lot number 21BBD357A; 18) Pack Number DYNJ16657G: UDI/DI 10193489362619 (each) 40193489362610 (case), Lot number 21GMD931A; 19) Pack Number DYNJ37370B: UDI/DI 10889942223633 (each) 40889942223634 (case), Lot number 21IMF238A; 20) Pack Number DYNJ26209N: UDI/DI 10193489483161 (each) 40193489483162 (case), Lot number 22CMF620A; 21) Pack Number DYNJ04581P: UDI/DI 10193489555479 (each) 40193489555470 (case), Lot number 23DMB984A; 22) Pack Number DYNJ67745A: UDI/DI 10195327409401 (each) 40195327409402 (case), Lot number 24ABA563Z; 23) Pack Number DYNJ09820J: UDI/DI 10888277840928 (each) 40888277840929 (case), Lot number 21BBG608A; 24) Pack Number DYNJ48884C: UDI/DI 10193489476651 (each) 40193489476652 (case), Lot number 21LMF921A; 25) Pack Number DYNJ57709B: UDI/DI 10193489424065 (each) 40193489424066 (case), Lot number 23JBR204A; 26) Pack Number DYNJ80172B: UDI/DI 10195327359188 (each) 40195327359189 (case), Lot number 23FBM928A; 27) Pack Number DYNJ46550F: UDI/DI 10193489338812 (each) 40193489338813 (case), Lot number 20LKB332A; 28) Pack Number DYNJ63472: UDI/DI 10193489745597 (each) 40193489745598 (case), Lot number 23EBD908A; 29) Pack Number DYNJ902455I: UDI/DI 10193489309584 (each) 40193489309585 (case), Lot number 20HBJ365Z; 30) Pack Number DYNJ61652: UDI/DI 10193489586855 (each) 40193489586856 (case), Lot number 20JKA923A; 31) Pack Number DYNJHS0235C: UDI/DI 10889942635245 (each) 40889942635246 (case), Lot number 21JMA297A; 32) Pack Number DYNJ21605J: UDI/DI 10195327108700 (each) 40195327108701 (case), Lot number 22BMG822Z; 33) Pack Number DYNJ52642F: UDI/DI 10195327441302 (each) 40195327441303 (case), Lot number 23HMB247A; 34) Pack Number DYNJ59313B: UDI/DI 10195327248338 (each) 40195327248339 (case), Lot number 23LME174A; 35) Pack Number DYNJ902039F: UDI/DI 10195327390631 (each) 40195327390632 (case), Lot number 23GBO615Z; 36) Pack Number DYNJ83049: UDI/DI 10195327234300 (each) 40195327234301 (case), Lot number 23AMI041A; 37) Pack Number DYNJ66821A: UDI/DI 10193489974928 (each) 40193489974929 (case), Lot number 23IBJ792A; 38) Pack Number DYNJ16629D: UDI/DI 10889942870585 (each) 40889942870586 (case), Lot number 20HKB315A; 39) Pack Number DYNJ67695A: UDI/DI 10195327512200 (each) 40195327512201 (case), Lot number 23LMG985A; 40) Pack Number DYNJS3032: UDI/DI 10884389408407 (each) 40884389408408 (case), Lot number 23BBO868Z; 41) Pack Number DYNJ44675K: UDI/DI 10195327127480 (each) 40195327127481 (case), Lot number 23BDA249A; 42) Pack Number DYNJ46190G: UDI/DI 10195327213855 (each) 40195327213856 (case), Lot number 23EMD906A; 43) Pack Number DYNJ68885A: UDI/DI 10195327187453 (each) 40195327187454 (case), Lot number 23FBO338A; 44) Pack Number DYNJ45578B: UDI/DI 10195327059187 (each) 40195327059188 (case), Lot number 23GBD205A; 45) Pack Number DYNJ43784A: UDI/DI 10889942903047 (each) 40889942903048 (case), Lot number 23HME180A; 46) Pack Number DYNJ04690Y: UDI/DI 10195327381752 (each) 40195327381753 (case), Lot number 23DME413A; 47) Pack Number DYNJQ0629F: UDI/DI 10889942565559 (each) 40889942565550 (case), Lot number 21FBP134A; 48) Pack Number DYNJ69256: UDI/DI 10193489918151 (each) 40193489918152 (case), Lot number 21JMI098A; 49) Pack Number DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374 (case), Lot number 23LMF829A; 50) Pack Number DYNJ19521P: UDI/DI 10193489941197 (each) 40193489941198 (case), Lot number 21IMD905A; 51) Pack Number DYNJ49947G: UDI/DI 10193489474152 (each) 40193489474153 (case), Lot number 21GMD742A; 52) Pack Number DYNJ51573C: UDI/DI 10195327561222 (each) 40195327561223 (case), Lot number 23LMG544A; 53) Pack Number DYNJ51575B: UDI/DI 10195327132248 (each) 40195327132249 (case), Lot number 22JMB950A; 54) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD323A; 55) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case), Lot number 23LMD611A; 56) Pack Number DYNJ55538B: UDI/DI 10193489574630 (each) 40193489574631 (case), Lot number 21BBG139A; 57) Pack Number DYNJ44022B: UDI/DI 10193489429329 (each) 40193489429320 (case), Lot number 22DBR220Z; 58) Pack Number DYNJ47704G: UDI/DI 10195327380724 (each) 40195327380725 (case), Lot number 23FMF488A; 59) Pack Number DYNJ82688: UDI/DI 10195327202903 (each) 40195327202904 (case), Lot number 23LMG154A; 60) Pack Number DYNJ82436A: UDI/DI 10195327362607 (each) 40195327362608 (case), Lot number 23EMD052A; 61) Pack Number DYNJ83622: UDI/DI 10195327285753 (each) 40195327285754 (case), Lot number 23FBN812A; 62) Pack Number DYNJ0785763L: UDI/DI 10193489351095 (each) 40193489351096 (case), Lot number 21LMF965A; 63) Pack Number DYNJ49994I: UDI/DI 10195327065775 (each) 40195327065776 (case), Lot number 21LMF123A; 64) Pack Number DYNJ66233A: UDI/DI 10195327176600 (each) 40195327176601 (case), Lot number 23LME717A; 65) Pack Number DYNJ55378C: UDI/DI 10193489443776 (each) 40193489443777 (case), Lot number 22GBJ071A; 66) Pack Number DYNJ69574A: UDI/DI 10195327242473 (each) 40195327242474 (case), Lot number 22JBI116Z; 67) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22CMA803A; 68) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA579A; 69) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case), Lot Number 22KMA581A

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

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

18 other products · FDA event 96374

This product is part of a recall event; the main page for the event is Medline procedure kits labeled as: C Scope Disposable Kit recalled.

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025	CLASS II	Medline procedure kits labeled as: C Scope Disposable Kit recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: AV Fistula Pack-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Laceration Tray recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: CV Neonatal Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Bilateral Facet Tray, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: AV Fistula Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Clovis Robotic-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Delivery Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Arthroscopy Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Aop/Basic Eye Pack-lf recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: General Endoscopy Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: A & A Knee Pack-lf, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: CT Biopsy Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Angio Pack, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: L S GYN PACK, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: C Section, Pack Number recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide
2 Apr 2025	CLASS II	Medline procedure kits labeled as: Angio Drape Pack recalled	Medline Industries LP - Northfield	Foreign Material	Nationwide

More recalls from Medline Industries LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	Medline Industries LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	Medline Industries LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	Medline Industries LP - Northfield	Labeling Errors	FL, IL

Other Surgical Instruments recalls

All 3,891

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide