Class II FDA device recall · Z-1451-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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 (case), Lot Number 23HMC484A;  13) Pack Number DYNJ46557K:  UDI/DI 10193489987225 (each) 40193489987226 (case), Lot Number 23FMF487A;  14) Pack Number DYNJ46557L:  UDI/DI 10195327466879 (each) 40195327466870 (case), Lot Number 23LMF146A;  15) Pack Number DYNJ48800C:  UDI/DI 10193489602173 (each) 40193489602174 (case), Lot Number 22IME600A;  16) Pack Number DYNJ38494G:  UDI/DI 10193489404890 (each) 40193489404891 (case), Lot Number 22IMF477A;  17) Pack Number DYNJ21134A:  UDI/DI 10080196818327 (each) 40080196818328 (case), Lot Number 23GMC030A;  18) Pack Number DYNJHTEY01:  UDI/DI 10888277078758 (each) 40888277078759 (case), Lot Number 23HBT532A;  19) Pack Number DYNJ50237A:  UDI/DI 10195327013967 (each) 40195327013968 (case), Lot Number 21KBW890A;  20) Pack Number DYNJ0190619G:  UDI/DI 10193489442588 (each) 40193489442589 (case), Lot Number 21IMH127A;  21) Pack Number DYNJ66623A:  UDI/DI 10195327001605 (each) 40195327001606 (case), Lot Number 22IMG395A;  22) Pack Number DYNJ82032:  UDI/DI 10195327162689 (each) 40195327162680 (case), Lot Number 22JBO961A;  23) Pack Number DYNJ52885D:  UDI/DI 10195327002077 (each) 40195327002078 (case), Lot Number 21JMH611A;  24) Pack Number DYNJ52885F:  UDI/DI 10195327118877 (each) 40195327118878 (case), Lot Number 22IMH094A;  25) Pack Number DYNJ45046A:  UDI/DI 10193489791112 (each) 40193489791113 (case), Lot Number 21FME768A;  26) Pack Number DYNJ82060A:  UDI/DI 10195327370145 (each) 40195327370146 (case), Lot Number 23LMF289A;  27) Pack Number DYNJ68940A:  UDI/DI 10195327326524 (each) 40195327326525 (case), Lot Number 23EMD688A;  28) Pack Number DYNJ0780084F:  UDI/DI 10889942089598 (each) 40889942089599 (case), Lot Number 21AMA688A;  29) Pack Number DYNJ0789014K:  UDI/DI 10193489954333 (each) 40193489954334 (case), Lot Number 21LMF629A;  30) Pack Number LYN030REFCA:  UDI/DI 10195327152383 (each) 40195327152384 (case), Lot Number 22GBI949A;  31) Pack Number VAL038EPWSB:  UDI/DI 10193489209976 (each) 40193489209977 (case), Lot Number 23GBE924A

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1451-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2025-02-11

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1451-2025 · Source: openFDA enforcement.