FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical Kilt recalled for attenuation material degradation over time
What this means
Burlington Medical is recalling certain Kilt models because the Xenolite 800 attenuation material used in them may break down over time, reducing how long the product lasts. The recall affects units made between January 16, 2025 and January 21, 2026.
- Check if your Kilt matches one of the recalled model numbers (C8K303, R8K303, R8KILT, or R8S302)
- Look at your product's serial number and manufacturing date
- Contact Burlington Medical for instructions on repair or replacement
- Do not discard the product until you hear from the manufacturer
The agency's original wording
Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Intended for
All ages
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
15,216 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Kilt
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2026Want us to check the next one for you?
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