Official recall notice
FDA DeviceClass IINotable
FDA Recall: IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Recall date
- 2026-07-08
- Brand
- Hamilton Medical AG
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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
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.
Affected products
GTIN: 07630002800839/ Lot # range: 00001 -19732