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Apparatus, Exhaust, Surgical

FDA product code FYD · Class 2 · General, Plastic Surgery

568
Registered devices
720
Adverse events
23
Recalls
75
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-03-16SurgiSmoke SolutionsCertain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
2026-03-16SurgiSmoke SolutionsCertain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
2026-03-16SurgiSmoke SolutionsCertain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
2015-07-20Stryker Instruments Div. of Stryker CorporationThe Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal an
2015-03-10Microtek Medical IncThis recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;
2015-03-10Microtek Medical IncThis recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;
2015-03-10Microtek Medical IncThis recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;
2015-03-10Microtek Medical IncThis recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;
2015-03-10Microtek Medical IncThis recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;

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