FDA Device Intelligence
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Apparatus, Suction, Operating-Room, Wall Vacuum Powered

FDA product code GCX · Class 2 · General Hospital

2,826
Registered devices
1,734
Adverse events
38
Recalls
87
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-08Stryker CorporationThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08Stryker CorporationThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08Stryker CorporationThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2025-12-26Cardinal Health 200, LLCThe firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. W
2025-06-18Stryker CorporationDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
2024-11-19Med Michigan Holding LlcIncomplete or partial pouch seals, which may result in a breach in the sterility.
2023-12-21Cardinal Health 200, LLCThe above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du
2023-12-21Cardinal Health 200, LLCThe above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du
2023-12-21Cardinal Health 200, LLCThe above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, du
2021-04-23Synaptive Medical IncDue to visible burrs/metal filings affixed along the suction tube inner perimeter.

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