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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Steris Corporation: Dual-Articulating Headrests Recalled for Failure to Lock and Stability Issues

Agency Publication Date: February 5, 2024
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Summary

Approximately 82 Dual Articulating Headrests manufactured by Steris Corporation are being recalled because they may not stay in place or fail to lock into position during medical procedures. This failure can lead to patient injury or significant delays during surgery. The affected units include two different models (Pad Ret and Velcro) manufactured between August 14, 2023, and October 26, 2023.

Risk

If the headrest fails to lock or shifts unexpectedly during a procedure, the patient's head and neck may move without warning, potentially causing physical injury or forcing the medical team to pause or delay the surgery to secure the equipment.

What You Should Do

  1. Identify if you have the affected Dual Articulating Headrest by checking the Reference (REF) and Part Numbers (P/N): look for Pad Ret P/N P141210805 (REF BF754) or Velcro P/N P141210813 (REF BF753).
  2. Verify the UDI-DI and manufacturing dates on your equipment: affected units have UDI-DI 00724995197643 or 00724995195885 and were manufactured between 2023-08-14 and 2023-10-26.
  3. If you identify an affected headrest, immediately contact your healthcare provider or the manufacturer, Steris Corporation, at 1-800-548-4873 to determine if the unit can be safely used or requires repair/replacement.
  4. Follow any specific instructions provided in the notification letter sent by Steris Corporation on December 12, 2023.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Model / REF:
P141210805
BF754
Z-0983-2024
Lot Numbers:
UDI-DI: 00724995197643
Date Ranges: Manufactured 2023-08-14 thru 2023-10-26
Product: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Model / REF:
P141210813
BF753
Z-0984-2024
Lot Numbers:
UDI-DI: 00724995195885
Date Ranges: Manufactured 2023-08-14 thru 2023-10-26

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93733
Status: Active
Manufacturer: Steris Corporation
Sold By: Steris Corporation; Medical distributors
Manufactured In: United States
Units Affected: 2 products (2; 80)
Distributed To: Arizona, California, Florida, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Nevada, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.