Sterile Procedural Trays — Class II medical device recall Z-1097-2023

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-1097-2023`
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	`10195327195656`, `10195327196363`, `10195327197377`, `10195327197421`, `10195327197926`, `10195327198763`, `10195327199524`, `10195327199852`, `10195327202316`, `10195327209315`, `10195327210045`, `10195327212179`, `10195327215576`, `10195327215873`, `10884389018422`, `10884389363966`, `10884389852736`, `10888277046412`, `10888277077744`, `10888277545397`, `10888277554696`, `10888277744141`, `10888277753648`, `10888277762909`, `10888277858459` and 75 more
Lot numbers	`22HBL505`, `22HBR114`, `22HBT060`, `22HBV066`, `22HBY104`, `22HMC138`, `22HMC946`, `22HMG756`, `22IBA906`, `22IBD173`, `22IBD245`, `22IBE887`, `22IBJ738`, `22IBK139`, `22IBL202`, `22IBN483`, `22IBN489`, `22IBN707`, `22IBO331`, `22IBO332`, `22IBS410`, `22IBT829`, `22IBU283`, `22IMC421`, `22IMD384`, `22IME064`, `22IME726`, `22IMF440`, `22IMG334`, `22IMH393`, `22JBA443`, `22JBA830`, `22JBB033`, `22JBD518`, `22JBD988`, `22JBE442`, `22JBF703`, `22JBF800`, `22JBG368`, `22JBG374` and 28 more
Model numbers	`CDS940869U`, `CDS985208B`, `DYNJ0111409L`, `DYNJ0376528J`, `DYNJ04446N`, `DYNJ0637509B`, `DYNJ0751097M`, `DYNJ0890114F`, `DYNJ09577J`, `DYNJ15916C`, `DYNJ16633C`, `DYNJ19751B`, `DYNJ24861D`, `DYNJ26870I`, `DYNJ30719C`, `DYNJ31889C`, `DYNJ33193A`, `DYNJ34330C`, `DYNJ34797I`, `DYNJ35435C`, `DYNJ35733F`, `DYNJ36624D`, `DYNJ37381C`, `DYNJ40334`, `DYNJ42208B` and 25 more

Product

Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY 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-1097-2023. 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.