Use cautionMedical device recall · FDA · Published May 22, 2026
Hamilton Medical IntelliCuff Recall: Cuff System Leakage Error Risk
Hamilton Medical recalls IntelliCuff portable blood pressure cuffs with REF 951001 due to potential "Cuff System Leakage" error causing continuous motor operation and pressure failure.
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.
Take action
Contact the company
📍Recalling firmHamilton Medical AGParc Industrial Vial 10 · Domat/Ems, Switzerland
“Hamilton Medical IntelliCuff Recall: Cuff System Leakage Error Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49079-hamilton-medical-intellicuff-recall-cuff-system-leakage-error-risk. Based on FDA recall #Z-2625-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2625-2026%22&limit=1).
Hamilton Medical AG voluntarily recalled the IntelliCuff, Portable automatic cuff pressure controller REF: 951001 on May 22, 2026, according to the FDA. The device may alarm with a "Cuff System Leakage" error and fail to maintain set pressure. Owners should contact the company for a remedy.
The cuff device may alarm with a "Cuff System Leakage" error due to reported complaints. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Context
GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Other recent recalls of similar products include Boston Scientific Rapid Refill System (June 30, 2026), Masimo Radius VSM Cuff Recall (Feb. 20, 2026), and Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026).
How to tell if you have this one
Check for IntelliCuff portable blood pressure cuffs with REF 951001. The product was sold with GTIN 07630002800839 and lot numbers from 00001 to 19732.
Look for a "Cuff System Leakage" error message on the device display.
Verify Product Details
Confirm the product has REF 951001 and was sold with GTIN 07630002800839 or lot numbers 00001-19732.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, Nebraska, New York, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Dakota, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2625-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2625-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.