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
- Radiation Shielding Apron (Half Apron)
- Model numbers
- R8HALF1B, R8HALF1H, R8HALF2B, R8HALF2H, R8HALF3B, R8HALF3H, R8HALF4B, R8HALF4H +12 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
Radiation shielding half aprons are used during radiology procedures to protect patients from scatter radiation.
Why This Is Dangerous
Attenuation material degradation over time could reduce shielding effectiveness and lifespan, potentially increasing radiation exposure risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
With 402 units distributed worldwide, patients and healthcare providers face potential exposure risk if shielding degrades. Immediate cessation of use is advised until remedies are provided.
Practical Guidance
How to identify if yours is affected
- Identify Xenolite 800 material on units and verify manufacture dates 01/16/2025 to 01/21/2026.
- Check UDI-DI codes where available on the label.
Where to find product info
UDI-DI on product label, packaging, or documentation; recall notice provides model list.
What timeline to expect
4-8 weeks for refund or replacement processing once a remedy is issued by Burlington Medical.
If the manufacturer is unresponsive
- Document all communications with Burlington Medical.
- Escalate to the FDA CDRH or the local regulatory authority if the supplier remains unresponsive.
- Consider legal counsel for unresolved cases involving potential exposure risk.
How to prevent similar issues
- Inspect shielding materials for wear or fading; avoid using older shielding with known material degradation trends.
- Ask suppliers for clear material specifications and shielding integrity testing results.
- Follow storage guidelines to minimize wear and tear on shielding aprons.
Documentation advice
Keep recall letter, model numbers, UDI-DI codes, and all correspondence. Photograph the labels and packaging for records.
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Product Details
Model numbers affected include R8HALF1B, R8HALF1H, R8HALF2B, R8HALF2H, R8HALF3B, R8HALF3H, R8HALF4B, R8HALF4H, R8HALF5B, R8HALF5H, R8HALF6B, R8HALF6H, R8HALFSETB, R8HALFSETH, S8HALF1H, S8HALF2B, S8HALF2H, S8HALF3B, S8HALF3H, S8HALF4B. UDI-DI codes corresponding to each model are provided in the recall notice. Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. Quantity: 402 units. Distribution: Worldwide with US distribution and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand,Taiw
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Models affected span R8HALF1B through S8HALF4B
- Xenolite 800 attenuation material used
- Manufacture dates 01/16/2025 to 01/21/2026
- No reported injuries to date
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Safety Guide
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