Steris Dual Articulating Headrest May Fail to Lock During Procedures
A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall for a functional failure with potential to cause patient injury during intended use. No injuries or illnesses are reported in the source material, placing this in the High severity category per the rubric for risk-of-harm products without reported injuries.
Plain-English summary
Steris Corporation has issued a recall for Dual Articulating Headrests (model BF754, part number P141210805). The headrest may not stay in place or fail to lock into position during patient procedures, creating a potential safety risk.
If the headrest fails to lock, it could result in patient injury or cause delays in ongoing procedures.
The affected units were manufactured between August 14, 2023 and October 26, 2023. They were distributed nationwide across multiple U.S. states (Arizona, California, Florida, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Nevada, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin) and Puerto Rico, as well as internationally to Australia, Canada, Mexico, and New Zealand.
Facilities using this product should have their units inspected to verify proper locking function. Contact Steris Corporation for guidance on inspection, repair, or replacement of affected equipment.
The recalled product
- Product
- Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
- Manufacturer
- Steris Corporation
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00724995197643
- date of manufacture 2023-08-14 thru 2023-10-26.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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