Z-2625-2026Class II

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Name: Z-2625-2026 IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Creator: Hamilton Medical AG
Published: 2026-05-22
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2026-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Hamilton Medical AG began a recall of IntelliCuff, Portable automatic cuff pressure controller REF: 951001 on 2026-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2625-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-22
Posted: 2026-07-01
Recalling firm: Hamilton Medical AG
Product: IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Product code: BSK Cuff, Tracheal Tube, Inflatable
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On May 22, 2026, Hamilton Medical issued a Urgent Medical Device Recall to affected consignees. Hamilton Medical ask consignees to take the following actions: 1. Identify affected devices (consider devices in use, in stock, spare devices etc.) and make them available for exchange of cuff connectors. 2. Continue to use IntelliCuff devices according to their labelling. Mitigate potential risks by following the actions described in point B. Type of Action to mitigate the risk . 3. Please fill in and sign Customer Reply Form (page 5) and send it to your Hamilton Medical distribution partner or subsidiary. This must be conducted as quickly as possible, but no later than 30 calendar days after receiving the Field Safety Notice.
Quantity in commerce: 962 units
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.
Product codes and lots: GTIN: 07630002800839/ Lot # range: 00001 -19732

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2625-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2625-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code BSK

K150893Class IIIntelliCuffHamilton Medical AG / cleared 2016-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)