Hamilton Medical AG recalls IntelliCuff

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2625-2026
• FDA 510(k) clearance · K150893The device's official FDA premarket clearance record
• FDA device classification · BSKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hamilton Medical AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.