FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical radiation protection caps recalled for material degradation
What this means
Burlington Medical issued a recall for certain radiation protection caps (models R8CAP, S8CAP, and U8CAP) manufactured between January 16, 2025 and January 21, 2026. The caps contain attenuation material that may degrade over time, which could reduce their ability to protect against radiation exposure.
- Check if your Burlington Medical cap matches one of the affected model numbers: R8CAP, S8CAP, or U8CAP
- Verify the manufacture date falls between 01/16/2025 and 01/21/2026
- Stop using the cap if it matches the recall criteria
- Contact Burlington Medical or your healthcare provider for replacement or guidance
The agency's original wording
Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Intended for
All ages
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
961 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Caps.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2026Want us to check the next one for you?
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