Recall Z-0984-2024— Steris Corporation

Name: FDA recall Z-0984-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-12

Class II · Ongoing

Class II FDA medical device recall by Steris Corporation, initiated 2023-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753. Reason: 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..

Recalling firm: Steris Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-12-12
Firm location: Mentor, OH, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.