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Medline Industries, Inc.

MEDLINE INDUSTRIES, INC. · Model DYKM1686 · UDI-DI 10193489536478

LRO Prescription
10
510(k) clearances
21,411
Adverse events (2 deaths)
1,077
Recalls
159
Facilities

Description

OR APPAREL KIT

Recalls

DateFirmReason
2026-08-18Cardinal Health 200, LLCThe kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10Medline Industries, LPKits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10Medline Industries, LPThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r

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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.