IntelliCuff, Portable automatic cuff pressure controller REF: 951001
FDA device recall Z-2625-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Hamilton Medical AG
- Reason for recall
- Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
- Action taken
- On May 22, 2026, Hamilton Medical issued a Urgent Medical Device Recall to affected consignees. Hamilton Medical ask consignees to take the following actions: 1. Identify affected devices (consider devices in use, in stock, spare devices etc.) and make them available for exchange of cuff connectors. 2. Continue to use IntelliCuff devices according to their labelling. Mitigate potential risks by following the actions described in point B. Type of Action to mitigate the risk . 3. Please fill in and sign Customer Reply Form (page 5) and send it to your Hamilton Medical distribution partner or subsidiary. This must be conducted as quickly as possible, but no later than 30 calendar days after receiving the Field Safety Notice.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- BSK
- Quantity affected
- 962 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.
- Date initiated
- 2026-05-22
- Date posted
- 2026-07-01
- Location
- Domat/Ems, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IntelliCuff (K150893) | Hamilton Medical AG | 2016-01-29 |