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Medline Industries, Inc.

MEDLINE INDUSTRIES, INC. · Model DYNJ61086C · UDI-DI 10198459228490

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510(k) clearances

Adverse events

Recalls

Facilities

Description

CRMC BURN PACK-LF

Recalls

Date	Firm	Reason
2026-01-07	Medline Industries, LP	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 packag
2026-01-07	Medline Industries, LP	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 packag
2024-10-09	MEDLINE INDUSTRIES, LP - Northfield	Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-09-11	ROi CPS LLC	Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using th
2022-11-17	MEDLINE INDUSTRIES, LP - Northfield	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
2017-06-26	Certified Safety Mfg Inc	Burn Sheet has possibility of being shredded.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.