FDA Device recall Z-1451-2025
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V by Medline Industries Northfield, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1451-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | 1) Pack Number DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case), Lot Number 23LMF853A; 2) Pack Number…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) 40889942 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1451-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.