FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Recall number
- Z-2625-2026
- Recalling firm
- Hamilton Medical AG
- Product
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Status
- Open, Classified
- Initiated
- 2026-05-22
- Posted
- 2026-07-01
- Terminated
- not on file
- 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 or subsidiary. This must be conducted as quickly as possible, but no later than 30 calendar days after receiving the Field Safety Notice.
- 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.
- Lot, serial or model codes
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- 510(k) numbers
- ["K150893"]
- PMA numbers
- not on file
- Product code
- BSK
- Firm FEI
- 3014766741
- Firm city
- Domat/Ems
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28