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Open, Classified

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

FDA Recall Z-2625-2026 · Posted 2026-07-01

Recalling FirmHamilton Medical AG
Recall StatusOpen, Classified
Product CodeBSK
Date Initiated2026-05-22
Product Quantity962 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.

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K150893IntelliCuffHamilton Medical AG · 2016-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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