Z-0984-2024Class II

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

Name: Z-0984-2024 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Creator: Steris Corporation
Published: 2023-12-12
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2023-12-12 / Open, Classified / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 on 2023-12-12. FDA classified it as Class II and gives the reason as "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". 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-0984-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-12
Posted: 2024-02-05
Recalling firm: STERIS Corporation
Product: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Product code: HBM Headrest, Neurosurgical
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Medical Device Recall notice dated December 5, 2023 was issued to distributors and customers via FedEx explaining the removal of specific affected product . The notice explains the labeled date of manufacture must fall between August 14, 2023 and October 26, 2023 the recall notice must have been received directly from STERIS. The 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. STERIS Service Technician will work with your facility to schedule a time to hand-deliver replacement head rest(s) and pick up your affected head rest(s). It is recommended all head rests impacted by this recall be immediately removed from service until it can be replaced. If you have further distributed this product, please identify all locations, notify them of this recall, and coordinate the collection of all affected head rest(s).
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0983-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-05
Z-0984-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-05

Product code HBM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)