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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

Ossur H / F: Miami J Select Cervical Collars Recalled for Adhesive Failure

Agency Publication Date: October 1, 2024
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Summary

Ossur H / F has recalled approximately 21,020 Miami J Select Collars and Collar Sets because the adhesive hooks on the sides of the device can peel off. These hooks are responsible for keeping the collar secured, and if they fail during repeated use, the collar may not properly immobilize the neck. This recall affects products sold between May 19, 2022, and June 5, 2023. If you have one of these collars, contact your healthcare provider or Ossur H / F for instructions on receiving a replacement or repair kit.

Risk

The adhesive hooks can gradually peel off the collar panel, leading to reduced immobilization of the cervical spine. If the neck is not properly stabilized following an injury or surgery, it could lead to further spinal injury or delayed healing.

What You Should Do

  1. Check your device for the following catalog numbers: Miami J Select Collar (MJS-101) or Miami J Select Collar Set (MJSR-101).
  2. Verify the Lot Number and GTIN on your packaging. Affected Lot Numbers fall in the range of MX220516 to MX230104. The GTIN for the MJS-101 is 05690967817008 and for the MJSR-101 is 05690967817145.
  3. Inspect the adhesive hooks on the sides of the collar panel to see if they are peeling or showing signs of poor adhesion.
  4. Contact your healthcare provider or the manufacturer, Ossur H / F, for further instructions regarding the device and to see if a replacement or corrective part is required.
  5. If you have additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and correction

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

Affected Products

Product: Miami J Select Collar
Model / REF:
MJS-101
UPC Codes:
05690967817008
Lot Numbers:
MX220516 to MX230104
Date Ranges: Sold between 2022-05-19 and 2023-06-05
Product: Miami J Select Collar Set
Model / REF:
MJSR-101
UPC Codes:
05690967817145
Lot Numbers:
MX220516 to MX230104
Date Ranges: Sold between 2022-05-19 and 2023-06-05

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95278
Status: Active
Manufacturer: Ossur H / F
Sold By: Authorized distributors; Medical facilities
Manufactured In: Iceland
Units Affected: 21,020
Distributed To: New Hampshire, Massachusetts, New York, New Jersey, Pennsylvania, Georgia, Maryland, North Carolina, Indiana, Florida, Arkansas, Tennessee, Kentucky, Ohio, Michigan, Illinois, Texas, Missouri, Colorado, Utah, Arizona, Washington, Oregon, California, New Mexico, Virginia, Iowa, Minnesota, Nebraska, South Carolina, Montana, Louisiana, Idaho, South Dakota, Alabama, Connecticut, Oklahoma, Alaska, 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.