Quick Facts at a Glance
- Recall Date
- May 22, 2026
- Hazard Level
- HIGH
- Brand
- Hamilton Medical AG
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Hamilton Medical AG
- Model numbers
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 22, 2026
Reported by FDA DEVICE
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hamilton Medical AG or your healthcare provider for instructions. Notification method: Letter
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Full Description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001. 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.. Classification: Class II. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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