Recall Z-1441-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated February 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
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.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-1441-2025
- Initiated
- February 11, 2025
- Posted by FDA
- March 25, 2025
- Product code
- FDE – Laparoscopy Kit
- Quantity
- 11,774 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1435-2025 Class II | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1436-2025 Class II | Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1437-2025 Class II | Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1438-2025 Class II | Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1439-2025 Class II | Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1440-2025 Class II | Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1442-2025 Class II | Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673GMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1443-2025 Class II | Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1444-2025 Class II | Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1445-2025 Class II | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328BMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1446-2025 Class II | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1447-2025 Class II | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1448-2025 Class II | Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1449-2025 Class II | Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1450-2025 Class II | Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1451-2025 Class II | Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1452-2025 Class II | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |
| Z-1453-2025 Class II | Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 02/11/2025Open, Classified |