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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

Emergency Products & Research: O.T.D. Optimum Traction Device Recalled for Pole Insert Adhesive Failure

Agency Publication Date: March 28, 2024
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Summary

Emergency Products & Research is recalling approximately 190,000 O.T.D - Optimum Traction Device (Street Orange) single-use traction splints due to a defect where the adhesive fails to secure the pole insert. This recall affects Model EP-800 devices from six specific lots manufactured in the United States. If the adhesive fails, the splint may not provide the necessary mechanical traction required to stabilize a patient's limb during emergency transport.

Risk

The failure of the adhesive can cause the pole insert to become loose or detached, rendering the traction splint ineffective. This could lead to a loss of limb stabilization for patients with fractures, potentially causing further injury, increased pain, or complications during emergency medical care.

What You Should Do

  1. Identify your device by checking the packaging or product label for 'O.T.D - Optimum Traction Device - Street Orange' and Model number EP-800.
  2. Check the lot numbers on your devices against the following affected codes: 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, or 122023-1.
  3. Immediately inspect any affected devices for signs of adhesive failure or loose pole inserts and do not use a device that appears compromised.
  4. Contact your healthcare provider or the manufacturer, Emergency Products & Research, located at 890 W Main St, Kent, Ohio, for further instructions on device replacement or potential refunds.
  5. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

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: O.T.D - Optimum Traction Device - Street Orange (Single use traction splint)
Model / REF:
EP-800
Lot Numbers:
20230523-04
09082023-11
09082023-12
122023-3
122023-2
122023-1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94207
Status: Active
Manufacturer: Emergency Products & Research
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 190,000 units
Distributed To: California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington

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.