- Recalling firm
- Hamilton Medical AG
- 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.
- Affected products (lot / model / serial)
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- Units affected
- 962 units
- Distribution pattern
- 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.
- Firm location
- Domat/Ems, N/A, Switzerland
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2625-2026
- Recall initiated
- May 22, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99035
- Last updated on HTM Vibe
- July 23, 2026