FDAHealthJanuary 7, 2026
Medline Industries, LP — Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 7, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
- Lot code
- 25ABV005
Additional details
1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 72 units.
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