FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical protective sleeves recalled for material degradation affecting lifespan
What this means
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
The agency's original wording
Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Intended for
Adults
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
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-1759-2026Want us to check the next one for you?
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