Dual Articulating Headrest May Fail to Lock During Surgery
Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. 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 medical device recall involving a potential locking mechanism defect that could result in patient injury. However, the source documents no reported illnesses or injuries, and the hazard is described as potential rather than confirmed, meeting the rubric criterion for High severity.
Plain-English summary
Steris Corporation is recalling Dual Articulating Headrests (Part Number P141210813, Reference BF753). These medical devices are used to position and support patients during surgical and medical procedures.
The headrests may not stay in place or may fail to lock into position during patient procedures, potentially resulting in patient injury or procedural delay.
The affected devices were distributed worldwide, including throughout the United States (Arizona, California, Florida, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Nevada, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin, and Puerto Rico), as well as Australia, Canada, Mexico, and New Zealand. Devices were manufactured between August 14, 2023 and October 26, 2023 (UDI-DI 00724995195885).
Healthcare providers in possession of these devices should verify whether they received affected units and consult the FDA recall notice for manufacturer guidance on corrective action.
The recalled product
- Product
- Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
- Manufacturer
- Steris Corporation
- Hazard
- locking-failure
- patient-injury
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: 00724995195885
- date of manufacture 2023-08-14 thru 2023-10-26.
Distribution
Distributed nationwide across the United States.
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