# FDA recall Z-2625-2026

> **Hamilton Medical AG** · Class II · device recall initiated 2026-05-22.

## Product

IntelliCuff, Portable automatic cuff pressure controller  REF: 951001

## 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.

## 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.

## Key facts

- **Recall number:** Z-2625-2026
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-22
- **Report date:** 2026-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Domat/Ems, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2026

## Citation

> MORVS. FDA recall Z-2625-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2625-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*