CLASS II ONGOING Device recall · Reported 24 Jan 2018 · FDA Enforcement Report

Intellicuff Standalone (PN 951001) Used to continuously recalled

Hamilton Medical is recalling Intellicuff Standalone (PN 951001) Used to continuously measure and automatically, distributed in Illinois, Texas. The recall was initiated on 20 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 1000 thru 2090; P/N 951001

Quantity recalled176 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0335-2018
FDA event ID: 77617
Recalling firm: Hamilton Medical, Reno, NV
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jun 2017
FDA classified: 12 Jan 2018
Reported: 24 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Jun 2017	Recall initiated by company
12 Jan 2018	Classified by FDA	+206 days
24 Jan 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Product as listed by the FDA

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.

Where it was distributed

US Distribution to IL and TX.

Illinois Texas

Questions about this recall

Why was it recalled?

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Which lots are affected?

Serial No. 1000 thru 2090; P/N 951001

Where was it sold?

US Distribution to IL and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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