FDAClass II · Medical device · Recalled May 13, 2026

Medline Convenience Kits recall — Medline Industries, LP

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2122-2026
Brand: Medline Industries
Classification: Class II
Units affected: 72 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Affected products

Medline Convenience Kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: 1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Distribution: Worldwide - US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98642
Recall initiated: January 7, 2026
FDA classified: May 7, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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