FDA-Device2026-04-08Class IIPROCESSING DEFECT
Burlington Medical Kilt Blockers recalled for attenuation material degradation
What this means
Burlington Medical Kilt Blockers with Xenolite 800 attenuation material made between January 2025 and January 2026 may degrade over time, reducing how long they work effectively. This affects 94 units across multiple model sizes distributed worldwide.
- Check if your Kilt Blocker model number starts with R8, S8, or U8 and was made between 01/16/2025–01/21/2026
- Contact Burlington Medical for instructions on replacement or repair
- Do not discard the product until you receive guidance 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
94 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Kilt Blockers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1765-2026Want us to check the next one for you?
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