Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Identifiers to compare

  • Lot range
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
IntelliCuff, Portable automatic cuff pressure controller REF: 951001GTIN: 07630002800839/ Lot # range: 00001 -19732962 unitsZ-2625-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.