Medline Industries, LP — Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
⚠️ 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) ADMIT KIT, Model Number: DYKA1343A
- Lot code
- 21CBV232
Additional details
1) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25HBG194; 18) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1090 units.
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