Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSC...
FDA Device Recall #Z-1441-2025 — Class II — February 11, 2025
Recall Summary
| Recall Number | Z-1441-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 11, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 11,774 units |
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
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Information
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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.