CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report

Dual Articulating Headrest, Velcro recalled by Steris

Steris is recalling Dual Articulating Headrest, Velcro, distributed nationwide in the US. The recall was initiated on 12 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.

Quantity recalled80

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-0984-2024
FDA event ID: 93733
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2023
FDA classified: 5 Feb 2024
Reported: 14 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Dec 2023	Recall initiated by company
5 Feb 2024	Classified by FDA	+55 days
14 Feb 2024	Published in enforcement report	+9 days

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

Reason for recall

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.

Nationwide Arizona California Florida Iowa Illinois Indiana Kansas Louisiana Minnesota Mississippi New Jersey Nevada Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Utah

Questions about this recall

Why was it recalled?

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

Which lots are affected?

UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 93733

This product is part of a recall event; the main page for the event is Dual Articulating Headrest, Pad Ret recalled by Steris.

Reported	Class	Recall	Company	Reason	Where
14 Feb 2024	CLASS II	Dual Articulating Headrest, Pad Ret recalled by Steris	Steris	Device Malfunction	Nationwide

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