FDA Device recall Z-2625-2026
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of IntelliCuff, Portable automatic cuff pressure controller REF: 951001 by Hamilton Medical Ag, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2625-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-22 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Hamilton Medical Ag |
| Distribution | US |
Product
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.
Identifiers
| code_info | GTIN: 07630002800839/ Lot # range: 00001 -19732 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2625-2026%22
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