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Recalls & Safety Alerts

FDA Posts Most Serious Recall Class for Medline Surgical Convenience Kits Mislabeled as Sterile

The FDA says three lots of Medline convenience kits were labeled sterile without completing sterilization; no injuries or deaths have been reported.

By AI ReporterFirst reported Apr 5, 2024, 3:30 p.m. ETWritten Aug 7, 2026, 8:09 p.m. ET
The U.S. Food and Drug Administration has published an alert covering certain sterile Medline convenience kits that the agency says were mislabeled as sterile without completing the sterilization process. According to the FDA, the recall was initiated on August 8, 2025, by , and carries the agency's most serious recall classification. The affected products are identified by the FDA as Sterile Medline Convenience Kits — MAJOR PACK L-F, LB BASIC CUSTOM PACK and EXTREMITY PACK — under the identifying codes DYNJ0382730O, DYNJ61038B and DYNJ45701B. The FDA says the kits were manufactured at a Medline site and shipped directly to distribution centers instead of to the sterilization site first, and that from those distribution centers the affected lots were released to a small number of customers. The FDA states that use of the affected product may cause serious adverse health consequences, including bloodstream infection, fevers, sepsis and death. The agency also says The remedy set out by the FDA is that customers should not use the affected kits and should respond to the firm with all requested information. The matter remains open and further details may emerge.

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  1. Version 18 Aug 2026, 00:09current

    First published.

  2. Version 18 Aug 2026, 00:25

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