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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069

Z-2127-2026

January 07, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98642
Status
Ongoing
Classification
Class II
Quantity
175 units
Official record key
device-enforcement:Z-2127-2026

Official wording

Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Code information: 1) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 21JBJ732; 2) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22ABJ831; 3) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22BBD031; 4) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22FBP788; 5) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBE795; 6) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBF936; 7) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBJ847; 8) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBL738; 9) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21ABK153; 10) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21CBZ902; 11) DYNJ32715F, UDI-DI: 10889942530038(each), 40889942530039(case), Lot Number: 21ADB529; 12) DYNJ50834C, UDI-DI: 10889942568178(each), 40889942568179(case), Lot Number: 21BDA710; 13) DYNJ51069, UDI-DI: 10889942118410(each), 40889942118411(case), Lot Number: 21BDB116

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.