FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical leg wraps recalled for material degradation affecting durability
OTHERNationwide distribution
Check your Burlington Medical leg wraps
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
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
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-1761-2026More Burlington Medical, LLC recalls
- FDA-Device2026-04-08Burlington Medical wrap aprons recalled for degraded radiation shielding material
- FDA-Device2026-04-08Burlington Medical half aprons recalled for degraded radiation shielding material
- FDA-Device2026-04-08Burlington Medical protective vests recalled for material degradation
- FDA-Device2026-04-08Burlington Medical Demi Half Aprons recalled for material degradation reducing lifespan
- FDA-Device2026-04-08Burlington Medical Kilt Blockers recalled for attenuation material degradation
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