Hamilton Medical Ag: Cuff, Tracheal Tube, Inflatable
Recall Summary Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller (model 951001) distributed nationwide and in Canada. The device may display a "Cuff System Leakage" error and malfunction by continuously pumping the motor while failing to maintain the pressure setting selected by the user. This is a Class II recall affecting medical facilities and users of this tracheal tube cuff control device.
- Recalling firm
- Hamilton Medical AG
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a0cf2df7-3720-46f4-9b3a-4c334c47f558