IntelliCuff, Portable automatic cuff pressure controller recallZ-2625-2026 · Hamilton Medical AG · initiated May 22, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2625-2026
- Status
- Open, Classified
- Initiated by the company
- May 22, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Hamilton Medical AG
- Quantity
- 962 units
- Product code
- BSK
- FDA submissions
- K150893
- 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.
Product description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Code information (models, lots, serial numbers)
GTIN: 07630002800839/ Lot # range: 00001 -19732
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntelliCuff 951001Hamilton Medical AG · Cuff, Tracheal Tube, Inflatable1 recall202 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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