FDA DevicesClass II
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Published: July 8, 2026Recall ID: Z-2625-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Affected Products
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Additional Source Details
| Field | Value |
|---|---|
| City | Domat/Ems |
| State | N/A |
| Event id | 99035 |
| Address 1 | Parc Industrial Vial 10 |
| Address 2 | N/A |
| Code info | GTIN: 07630002800839/ Lot # range: 00001 -19732 |
| Postal code | N/A |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 962 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmHamilton Medical AG
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.