FDA-Device2026-04-08Class IIPROCESSING DEFECT

Burlington Medical protective sleeves recalled for material degradation affecting lifespan

OTHERNationwide distribution

Check Burlington Medical protective sleeves

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.

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

Potential for attenuation degradation over time, decreasing the lifespan.

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
1,129 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Protective Sleeves.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2026

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