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Blood Pressure Cuff
FDA product code DXQ · Class 2 · Cardiovascular
11,704
Registered devices
492
Adverse events
27
Recalls
199
510(k) clearances
Devices with this code
MABIS — D-M-S HOLDINGS, INC.Aneroids (82 etc.) — RASHMAN CORPORATIONBAUM — W. A. BAUM CO., INC.BAUM — W. A. BAUM CO., INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Diagnostix™ — AMERICAN DIAGNOSTIC CORPUnimed — Unimed Medical Supplies, Inc.Durable BP Cuff — SUNTECH MEDICAL, INC.Unimed — Unimed Medical Supplies, Inc.Durable BP Cuff — SUNTECH MEDICAL, INC.Unimed — Unimed Medical Supplies, Inc.Orantech — Orantech Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.All Purpose Cuff — SUNTECH MEDICAL, INC.Diagnostix™ — AMERICAN DIAGNOSTIC CORPUnimed — Unimed Medical Supplies, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCDeRoyal — DEROYAL INDUSTRIES, INC.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Baxter Healthcare Corporation | Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in th |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 | Baxter Healthcare Corporation | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2024-04-09 | GE Medical Systems Information Technologies Inc | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
| 2022-05-16 | Volcano Corp | Due to a potential failed sterilization process. |
| 2019-07-12 | ICU Medical, Inc. | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring |
| 2019-06-03 | Suntech Medical, Inc. | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package. |
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