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U.S. Department of Health and Human Services

Class 2 Device Recall Hamilton Medical IntelliCuff, Portable automatic cuff pressure controller

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 Class 2 Device Recall Hamilton Medical IntelliCuff, Portable automatic cuff pressure controllersee related information
Date Initiated by FirmMay 22, 2026
Date PostedJuly 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2625-2026
Recall Event ID 99035
510(K)NumberK150893 
Product Classification Cuff, tracheal tube, inflatable - Product Code BSK
ProductIntelliCuff, Portable automatic cuff pressure controller REF: 951001
Code Information GTIN: 07630002800839/ Lot # range: 00001 -19732
FEI Number 3014766741
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Parc Industrial Vial 10
Domat/Ems Switzerland
For Additional Information ContactBret Everett
USA-800-4266331 Ext. 7796
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionOn 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 in Commerce962 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSK
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