Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

FDA Recall #Z-1410-2026 — Class II — January 7, 2026

Recall #Z-1410-2026 Date: January 7, 2026 Classification: Class II Status: Ongoing

Product Description

Reason for Recall

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.

Recalling Firm

Medline Industries, LP — Northfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1070 units

Distribution

Worldwide distribution - US Nationwide.

Code Information

1) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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