Hood, Surgical
General, Plastic Surgery · 21 CFR 878.4040
Recent MDR events
51 adverse event reports on file
- FLYTE SURGICOOL HOODJul 29, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-99183
- T7 HOOD W ANTI-REFLECTIVE LENSJul 29, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-99232
- HOOD, T7, HB, STDApr 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00910
- T7 HOOD W ANTI-REFLECTIVE LENSApr 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00909
- T7PLUS HOOD W PEELAWAY SHIELDApr 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00923
- T7PLUS HOOD W ANTI-REFLECTIVE LENSJan 31, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00375
- T7 HOOD W ANTI-REFLECTIVE LENSJan 22, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00326
- FLYTE SURGICOOL HOODJan 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00164
- FLYTE SURGICOOL HOOD, PEELAWAYJan 21, 2025MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2025-00165
- T7 HOOD W PEELAWAY SHIELDOct 22, 2024MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2024-02191
Event type breakdown
Recalls
3 recall events for this product code
- O&M HALYARD, INC.Open, ClassifiedApr 2, 2024
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
Z-1461-2024 · View FDA record ↗ - VIASYS Med SystemsTerminatedOct 4, 2005
Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bu
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Z-0001-06 · View FDA record ↗ - VIASYS Med SystemsTerminatedOct 4, 2005
Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bu
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
Z-0002-06 · View FDA record ↗
Registered firms
56 firms currently registered for this product code
Maya Medical Top Trade Ltd.
Tsofit Central, IL
Sterigenics Costa Rica S.r.l.
El Coyol Alajuela, CR
Stryker Instruments
Portage, MI, US
Sterigenics S. De R.l. De C.v.
Cuautitlan Izcalli Mexico, MX
Stryker Us Supply Chain Operations
Plainfield, IN, US
Isomedix Operations, Inc
ONTARIO, CA, US
Thi Total Healthcare Innovation Gmbh
Feistritz im Rosental Karnten, AT
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Medi.plan Gmbh & Co. Kg
Dortmund North Rhine-Westphalia, DE
Stryker Tijuana Operations
Tijuana Baja California, MX
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Steris Spa
CALCINATE Bergamo, IT
Zimmer Surgical, Inc.
Dover, OH, US
Ad Supply Group Limited
London London, City of, GB
Cbr Enterprise Limited
Hong Kong, HK
Thi Medikal Sanayi Ticaret A.s
Menderes Izmir, TR
510(k) clearances
13 clearances for this product code
- Thi Total Healthcare Innovation GmbHOct 17, 2023
K222214 · ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- Stryker CorporationMar 21, 2020
K200493 · Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- Stryker CorporationJun 26, 2014
K140588 · FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- Chicago Assoc. For Retarded CitizensDec 12, 1990
K904969 · HOOD, OPERATING, SURGICAL
- Anago, Inc.Nov 21, 1990
K904276 · DISPOSABLE BEARD COVER
- Biomedical Devices, Inc.Oct 19, 1990
K903533 · STERI-SHIELD
- Biomedical Devices, Inc.Aug 17, 1990
K902677 · STERI-SHIELD
- James River Corp.Feb 24, 1988
K880431 · CARETEX SURGEON'S HOODS