Recall Z-2625-2026— Hamilton Medical AG
Class II · Ongoing
Class II FDA medical device recall by Hamilton Medical AG, initiated 2026-05-22. It names one FDA 510(k) clearance: K150893. Product: IntelliCuff, Portable automatic cuff pressure controller REF: 951001. Reason: 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..
- Recalling firm
- Hamilton Medical AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-22
- Firm location
- Domat/Ems, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.