Sterile Procedural Trays — Class II medical device recall Z-1095-2023

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-15, distributed nationwide. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the st

Recall number	`Z-1095-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2022-11-17
Classified	2023-02-06
Reported by FDA	2023-02-15
Distributed	Nationwide (US)
Countries outside the US	AE, CA, JP, MX, PA
Reason classes	sterility
UPC / GTIN / UDI-DI	`10080196931101`, `10193489346626`, `10193489352382`, `10193489352399`, `10193489448825`, `10193489587876`, `10193489760743`, `10193489916065`, `10193489942545`, `10193489997354`, `10195327037789`, `10195327177669`, `10195327198794`, `10888277971592`, `10889942227563`, `10889942292066`, `40080196931102`, `40193489346627`, `40193489352383`, `40193489352390`, `40193489448826`, `40193489587877`, `40193489760744`, `40193489916066`, `40193489942546` and 7 more
Lot numbers	`22HBG403`, `22HBJ348`, `22HBN241`, `22HBY420`, `22HDC265`, `22IBF606`, `22IBN397`, `22IBS350`, `22IBT956`, `22IDB984`, `22JBC143`, `22JBE699`, `22JBG389`, `22JBL816`, `22JBS972`, `22JBW843`, `22JBY531`, `22JBY558`, `22JDA005`, `22JDA822`, `22JME546`, `22JME931`, `22KBA929`
Model numbers	`DYNJ0842521C`, `DYNJ0843936F`, `DYNJ14064`, `DYNJ31639B`, `DYNJ35056A`, `DYNJ46539J`, `DYNJ47859C`, `DYNJ49413A`, `DYNJ54487A`, `DYNJ62174A`, `DYNJ63785`, `DYNJ66365`, `DYNJ67875`, `DYNJ69446`, `DYNJ82588`, `DYNJ908778`

Product

Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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-1095-2023. 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.