Home › Device types › KCY
Tourniquet, Pneumatic
FDA product code KCY · Class 1 · General, Plastic Surgery
1,449
Registered devices
1,989
Adverse events
47
Recalls
34
510(k) clearances
Devices with this code
Orantech — Orantech Inc.ASP MEDICAL — Asp Global, LLCn.a. — VBM Medizintechnik GmbHOrantech — Orantech Inc.SmartPump — STRYKER CORPORATIONZimmer — ProvisionMEDLINE — MEDLINE INDUSTRIES, INC.n.a. — VBM Medizintechnik GmbHOrantech — Orantech Inc.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.Cuff Cover — VBM Medizintechnik GmbHTourniquet Cuff — DAESUNG MAREF CO.,LTD.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.A.T.S.® Personalized Pressure® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.Color Cuff — STRYKER CORPORATIONTourniquet Cuff — DAESUNG MAREF CO.,LTD.A.T.S.® Personalized Pressure® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.Sterile Disposable Contour Cuff — Delfi Medical Innovations IncZimmer — ProvisionASP MEDICAL — Asp Global, LLCMEDLINE RENEWAL — MEDLINE INDUSTRIES, INC.Hammarplast Medical — Provision
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-09 | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result i |
| 2026-06-09 | Zimmer Surgical Inc | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result i |
| 2026-03-12 | Stryker Sustainability Solutions | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. |
| 2025-12-24 | Zimmer Surgical Inc | Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or exte |
| 2025-12-24 | Zimmer Surgical Inc | Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or exte |
| 2025-07-02 | Stryker Corporation | Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss great |
| 2024-05-31 | Stryker Sustainability Solutions | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. |
| 2023-03-01 | Stryker Corporation | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu |
| 2023-03-01 | Stryker Corporation | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu |
| 2023-03-01 | Stryker Corporation | Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu |
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