Quick Facts at a Glance
- Recall Date
- February 11, 2026
- Hazard Level
- HIGH
- Brand
- Burlington Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Burlington Medical
- Product type
- Thyroid Shield
- Model numbers
- R8COPEH, R8TSBBB, R8TSBBN, R8TSBBR, R8TSBBT, R8TSBHB, R8TSBHN, R8TSBHR +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 11, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for attenuation degradation over time, decreasing the lifespan.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The Burlington Medical Thyroid Shield is used to protect the thyroid during radiologic imaging. It is distributed globally to clinics and hospitals.
Why This Is Dangerous
Over time, attenuation degradation could reduce shielding effectiveness, potentially increasing radiation exposure during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
41,962 units recalled with no reported injuries. Immediate stop-use is advised pending recall instructions.
Practical Guidance
How to identify if yours is affected
- Review model numbers: R8COPEH, R8TSBBB, R8TSBBN, R8TSBBR, R8TSBBT, R8TSBHB, R8TSBHN, R8TSBHR, R8TSBHT.
- Check Xenolite 800 attenuation material used in models.
- Look for date codes indicating manufacture between 2025-01-16 and 2026-01-21.
Where to find product info
Recall notice and detailed instructions are available via the FDA enforcement report and Burlington Medical communications.
What timeline to expect
Refund or replacement processing timelines are not specified in the notice.
If the manufacturer is unresponsive
- Document all contact attempts with Burlington Medical.
- Escalate to the CPSC if the company does not respond within a reasonable period.
How to prevent similar issues
- Verify device recall status before use.
- Ask clinics to confirm device model and manufacture date.
- Ensure vendors provide recall-compliant replacements or refunds.
Documentation advice
Keep the recall letter, all model numbers, and any correspondence with Burlington Medical for records.
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Product Details
Model numbers: R8COPEH; R8TSBBB; R8TSBBN; R8TSBBR; R8TSBBT; R8TSBHB; R8TSBHN; R8TSBHR; R8TSBHT. Sold worldwide, including US nationwide, and distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Manufactured 2025-01-16 to 2026-01-21. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 41,962 units recalled worldwide
- Attenuation degradation identified as the defect
- Worldwide distribution with US nationwide and international reach
- Model numbers include R8COPEH and nine other SKUs
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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