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Accessory, Surgical Apparel

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

2,165
Registered devices
128
Adverse events
9
Recalls
56
510(k) clearances

Devices with this code

Critical Cover — Alpha Pro Tech, Inc.Unipack — UNIPACK MEDICAL CORPORATIONHalyard — O&M HALYARD, INC.Cranberry — ASCEND EAGLE INCORPORATEDLab Coats Knitted Cuffs & Collar with Pockets, Large, Blue — Dynarex CorporationMAXI-GARD — HENRY SCHEIN, INC.Curaplex — BOUND TREE MEDICAL, LLCCustoMed — KENPAX INTERNATIONAL LIMITEDEMSRUN — Wuxi Emsrun Technology Co., Ltd.Tronex International, Inc. — TRONEX INTERNATIONAL, INC.MediChoice — OWENS & MINOR DISTRIBUTION, INC.MEDLINE — MEDLINE INDUSTRIES, INC.40767 Face Protection Shield — XODUS MEDICAL, INC.Tronex International, Inc. — TRONEX INTERNATIONAL, INC.JMU — JMU DENTAL, INCPremium Plus — Premium Plus International LimitedUnipack — UNIPACK MEDICAL CORPORATIONTronex International, Inc. — TRONEX INTERNATIONAL, INC.ASP MEDICAL — Asp Global, LLCA Plus — A PLUS INTERNATIONAL INC.CARDINAL HEALTH — Cardinal Health 200, LLCDukal — Dukal LLCMAXAIR — Syntech, Int'l Inc.GLOVE LINER — George Glove Company, 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.