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Medline procedure kits labeled as recallZ-1441-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

Recall details

Recall number
Z-1441-2025
Status
Open, Classified
Initiated by the company
Feb 11, 2025
Posted by the FDA
Mar 25, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
11,774 units
Product code
FDE
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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

Devices named in this recall

65 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96374).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page