Moderate riskFDA DeviceClass II

Burlington Medical protective sleeves recalled for material degradation affecting lifespan

Burlington Medical protective sleeves made with Xenolite 800 material may degrade over time, reducing how long they last. This affects sleeves manufactured between January 16, 2025 and January 21, 2026. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your Burlington Medical protective sleeves match one of the affected model numbers (R8SL, R8SL3, S8SL, S8SL3, U8SL, or U8SL3)
  2. Look at the product code on your sleeve packaging to confirm it's affected
  3. Contact Burlington Medical for replacement or refund instructions

Is yours affected?

Compare your label or packaging with the recalled product.

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

This recall covers 13 products — see all of them.

Details

Units affected
1,129 units
Illnesses reported
None reported
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Classification
Class II
Recall number
Z-1759-2026

In the FDA's words

Description
Burlington Medical, Protective Sleeves. 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: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS). 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: 1,129 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.

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