Burlington Medical caps may lose radiation attenuation over time
Burlington Medical is recalling protective caps made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: degraded attenuation reduces the radiation protection the product is worn to provide, and no injuries are stated.
Plain-English summary
Burlington Medical is recalling its protective caps, models R8CAP, S8CAP and U8CAP. About 961 units were distributed nationwide in the United States and internationally to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay and Vietnam. The FDA has classified this recall as Class II.
There is potential for attenuation degradation over time, decreasing the lifespan of the product.
All serial numbers manufactured with Xenolite 800 attenuation material between 16 January 2025 and 21 January 2026 are affected, across UDI-DIs including 00840331272185, 00840331272208 and 00840331272222.
Facilities can identify affected caps by the model number and UDI above, and may contact Burlington Medical for further information.
The recalled product
- Product
- Burlington Medical, Caps.
- Manufacturer
- Burlington Medical, LLC
- Hazard
- attenuation-degradation
- radiation-exposure
- reduced-lifespan
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL)
- 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP
- UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL)
- 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP
- UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL)
- 00840331272215 (CAP8-U8CAP-SM_MD).
Distribution
Distributed nationwide across the United States.
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