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Accessory, Surgical Apparel

FDA product code LYU · Class 1 · General, Plastic Surgery

2,020
Registered devices
127
Adverse events
9
Recalls
56
510(k) clearances

Devices with this code

Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue — Dynarex CorporationCritical Cover — Alpha Pro Tech, Inc.Critical Cover — Alpha Pro Tech, Inc.ASP MEDICAL — Asp Global, LLCCARDINAL HEALTH — Cardinal Health 200, LLCBatrik Save Face Half Face Shield/Drape — Batrik Medical Manufacturing IncCARDINAL HEALTH — Cardinal Health 200, LLCVR — POLYCONVERSIONS, INC.Flyte — STRYKER CORPORATIONTronex International, Inc. — TRONEX INTERNATIONAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMDU7023S — UNIVET SRLVIVIT Supply — Vivit Supply LLCA Plus — A PLUS INTERNATIONAL INC.MAXI-GARD — HENRY SCHEIN, INC.Critical Cover — Alpha Pro Tech, Inc.Critical Cover — Alpha Pro Tech, Inc.Cranberry — ASCEND EAGLE INCORPORATEDVR — POLYCONVERSIONS, INC.Resilient Medical Solutions — Resilient Medical Solutions, LLCVR — POLYCONVERSIONS, INC.Curaplex — BOUND TREE MEDICAL, LLCCritical Cover — Alpha Pro Tech, Inc.MAXI-GARD — HENRY SCHEIN, INC.

Recent recalls

DateFirmReason
2023-05-18MEDLINE INDUSTRIES, LP - NorthfieldProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15MEDLINE INDUSTRIES, LP - NorthfieldPotential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2021-01-07Cardinal Health 200, LLCGowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
2017-09-11Zimmer Biomet, Inc.Cut resistant surgical glove liners lack sterility assurance.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.