IntelliCuff — Class II medical device recall Z-2625-2026
Ongoing recall by Hamilton Medical AG, reported 2026-07-08, distributed nationwide. Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the mot
| Recall number | Z-2625-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Domat/Ems, N/A, Switzerland |
| Recall initiated | 2026-05-22 |
| Classified | 2026-07-01 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 962 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07630002800839 |
| Model numbers | 951001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2625-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.