IntelliCuff recall
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Why was IntelliCuff 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 07630002800839/ Lot # range: 00001 -19732
- Product
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Recalling firm
- Hamilton Medical AG
- 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.
- Recall date
- July 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)