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FDA
Food and Drug Administration · Recall Z-2625-2026 · May 22, 2026

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Hamilton Medical AG

The hazard

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. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model GTIN: 07630002800839/ Lot # range: 00001 -19732UPC 07630002800839

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.