Data Foundry

Medical device recalls 2025

Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF — Class II medical device recall Z-1451-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L

Recall numberZ-1451-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-02-11
Classified2025-03-25
Reported by FDA2025-04-02
DistributedNationwide (US)
Countries outside the USCA
Quantity5,132 units
Reason classespackaging, device malfunction
UPC / GTIN / UDI-DI10080196818327, 10193489209976, 10193489404890, 10193489442588, 10193489556636, 10193489602173, 10193489635348, 10193489761962, 10193489791112, 10193489826722, 10193489954333, 10193489969863, 10193489987225, 10195327001605, 10195327002077, 10195327013967, 10195327062736, 10195327068370, 10195327118877, 10195327152383, 10195327162689, 10195327176365, 10195327221393, 10195327326524, 10195327357313 and 37 more
Lot numbers20EBE340A, 20JKA823A, 21AMA688A, 21FME768A, 21IMG706A, 21IMH127A, 21JMH611A, 21KBW890A, 21LMF629A, 22GBI949A, 22IMD667A, 22IME600A, 22IMF477A, 22IMG395A, 22IMG784A, 22IMG811A, 22IMH094A, 22JBO961A, 23CLA046A, 23EMD688A, 23FMF487A, 23GBE924A, 23GMC030A, 23HBT532A, 23HMC484A, 23HME435A, 23IMC700A, 23LMF146A, 23LMF289A, 23LMF853A, 24AMI654A

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1451-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.