FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical frontal aprons recalled for degrading radiation shielding material
What this means
Burlington Medical is recalling certain frontal aprons (radiation protection garments) with Xenolite 800 shielding material made between January 2025 and January 2026. The material may degrade over time, reducing its ability to protect against radiation exposure. No injuries have been reported.
- Check if your apron matches one of the affected model numbers (C8F17, R8601, R8A10, R8F01, or R8F17) and was made between 01/16/2025–01/21/2026
- Contact Burlington Medical for replacement or repair instructions
- Do not discard the apron; keep it until you receive guidance from the manufacturer
The agency's original wording
Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
Affected count
14323
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Frontal Aprons
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1756-2026Want us to check the next one for you?
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