Recall Z-2625-2026 ยท BSK Cuff, Tracheal Tube, Inflatable
Hamilton Medical AG
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
| Date | Jul 1, 2026 (initiated May 22, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| 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 |
| Quantity | 962 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150893 | IntelliCuff Hamilton Medical AG, Jan 29, 2016 |