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.
What this means for you
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
- Hazard
- locking-failure
- patient-injury-risk
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
Distributed nationwide across the United States.
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