IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Summary
The FDA issued a Class II for IntelliCuff, Portable automatic cuff pressure controller REF: 951001 by Hamilton Medical AG. 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 mai.
Details
Source
Device Recall
External ID
Z-2625-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Lot/Code Info: GTIN: 07630002800839/ Lot # range: 00001 -19732
Quantity Affected: 962 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-22
Company
Domat/Ems, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Hamilton Medical AG has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2625-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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