FDA Medical Device Recalls (openFDA)
Steris Corporation: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
- Recall number
- Z-0984-2024
- Recalling firm
- Steris Corporation
- Product
- Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
- Status
- Open, Classified
- Initiated
- 2023-12-12
- Posted
- 2024-02-05
- Terminated
- not on file
- 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.
- 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
- 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.
- Lot, serial or model codes
- UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBM
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28