Recall Weekly
Moderate riskFDA DeviceClass II

Burlington Medical radiation protection caps recalled for material degradation

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.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your Burlington Medical cap matches one of the affected model numbers: R8CAP, S8CAP, or U8CAP
  2. Verify the manufacture date falls between 01/16/2025 and 01/21/2026
  3. Stop using the cap if it matches the recall criteria
  4. Contact Burlington Medical or your healthcare provider for replacement or guidance
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Burlington Medical, Caps.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 13 products — see all of them.

Details

Units affected
961 units
Illnesses reported
None reported
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Classification
Class II
Recall number
Z-1760-2026

In the FDA's words

Description
Burlington Medical, Caps. Potential for attenuation degradation over time, decreasing the lifespan. All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; 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: 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 quantity: 961 units
Hazard
Potential for attenuation degradation over time, decreasing the lifespan.

13 products in this recall

Burlington Medical radiation protective apparel recalled for weakening shielding

Burlington Medical is recalling 13 radiation protective products, including thyroid shields, vests, kilts, and aprons. The shielding may weaken over time, which shortens how long the garments provide protection. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

OtherMedical devicesSold nationwideMore from FDA Device