FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical leg wraps recalled for material degradation affecting durability
What this means
Burlington Medical leg wraps manufactured between January 2025 and January 2026 may experience material degradation over time, which could reduce how long the wraps last and their effectiveness. The issue affects specific models that used Xenolite 800 attenuation material. No injuries have been reported.
- Check if your leg wrap model matches one of the affected models (R8LGW1–3, S8LGW1–4, or U8LGW1–2, U8LGW4)
- Look at the product code on your packaging to confirm it's affected
- Contact Burlington Medical for instructions on replacement or return
- Stop using the wraps if you notice reduced support or visible degradation
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
103 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Leg Wraps.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1761-2026Want us to check the next one for you?
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