FDAClass IIFebruary 14, 2024

Dual Articulating Headrest recall

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

Why was Dual Articulating Headrest 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Recalling firm
Steris Corporation
Quantity
80
Distribution
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.
Recall date
February 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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