Recall Z-1451-2025
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) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT PACK, Pack Number DYNJ0417156G; 7) CATARACT PACK, Pack Number DYNJ60411A; 8) CATARACT PACK, Pack Number DYNJ52649F; 9) CATARACT PACK - 30843, Pack Number DYNJVB1076B; 10) CATARACT PACK-LF, Pack Number DYNJ0317858M; 11) CATARACT-LF, Pack Number DYNJ40081F; 12) ENT PACK, Pack Number DYNJ38916B; 13) EYE CATARACT PK, Pack Number DYNJ46557K; 14) EYE CATARACT PK, Pack Number DYNJ46557L; 15) EYE PACK, Pack Number DYNJ48800C; 16) EYE PACK, Pack Number DYNJ38494G; 17) EYE PACK, Pack Number DYNJ21134A; 18) EYE PACK 1, Pack Number DYNJHTEY01; 19) EYE PACK II-LF, Pack Number DYNJ50237A; 20) EYE PBM-LF, Pack Number DYNJ0190619G; 21) MZ GENERAL EYE PACK, Pack Number DYNJ66623A; 22) OCULAR PLASTICS, Pack Number DYNJ82032; 23) OPHTHALMOLOGY PACK, Pack Number DYNJ52885D; 24) OPHTHALMOLOGY PACK, Pack Number DYNJ52885F; 25) PK, OPHTH-RETINA, Pack Number DYNJ45046A; 26) PLASTIC PACK, Pack Number DYNJ82060A; 27) RETINAL DSC, Pack Number DYNJ68940A; 28) SMSC- EYE PACK HOSP&CLINIC-LF, Pack Number DYNJ0780084F; 29) STRABISMUS PACK-LF, Pack Number DYNJ0789014K; 30) RETINAL PACK, Pack Number LYN030REFCA; 31) EYE PACK WHITEWATER SC, Pack Number VAL038EPWSB
Codes / lots: 1) Pack Number DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case), Lot Number 23LMF853A; 2) Pack Number DYNJ39921B: UDI/DI 10195327176365 (each) 40195327176366 (case), Lot Number 24AMI654A; 3) Pack Number DYNJ45662C: UDI/DI 10193489556636 (each) 40193489556637 (case), Lot Number 20EBE340A; 4) Pack Number DYNJ56056B: UDI/DI 10193489635348 (each) 40193489635349 (case), Lot Number 20JKA823A; 5) Pack Number DYNJ56553B: UDI/DI 10193489761962 (each) 40193489761963 (case), Lot Number 21IMG706A; 6) Pack Number DYNJ0417156G: UDI/DI 10889942067428 (each) 40889942067429 (case), Lot Number 22IMG784A; 7) Pack Number DYNJ60411A: UDI/DI 10195327221393 (each) 40195327221394 (case), Lot Number 22IMG811A; 8) Pack Number DYNJ52649F: UDI/DI 10195327357313 (each) 40195327357314 (case), Lot Number 23HME435A; 9) Pack Number DYNJVB1076B: UDI/DI 10195327062736 (each) 40195327062737 (case), Lot Number 23CLA046A; 10) Pack Number DYNJ0317858M: UDI/DI 10889942399789 (each) 40889942399780 (case), Lot Number 22IMD667A; 11) Pack Number DYNJ40081F: UDI/DI 10195327068370 (each) 40195327068371 (case), Lot Number 23IMC700A; 12) Pack Number DYNJ38916B: UDI/DI 10193489969863 (each) 40193489969864…
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-1451-2025
- Initiated
- February 11, 2025
- Posted by FDA
- March 25, 2025
- Product code
- OJK – Eye Tray
- Quantity
- 5,132 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-1441-2025 Class II | Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH…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-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 |