Burlington Medical recalled 15,438 attenuation vests distributed worldwide after potential attenuation degradation over time. The vests use Xenolite 800 attenuation material and were produced between January 16, 2025 and January 21, 2026. Healthcare providers and patients should stop using the vest immediately and follow recall instructions.
Potential for attenuation degradation over time, decreasing the lifespan.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
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Quantity recalled: 15,438 units. Worldwide distribution with US nationwide and international distribution to Canada, Australia, Bangladesh, and other countries. Manufactured with Xenolite 800 attenuation material between 01/16/2025 and 01/21/2026. Model numbers include C8PVEST and C8VEST with multiple variants (see UDI codes). UDI-DI numbers include 00840331297652 and 00840331297645 for select variants.
The vest may experience attenuation degradation over time, reducing its protective lifespan. This could compromise shielding during diagnostic procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Do not dispose of the vest until instructed. 3. Follow recall instructions provided by Burlington Medical or your healthcare provider. 4. Check model numbers and manufacture dates to confirm if affected. 5. For refunds or replacements, follow the recall notice instruction.
Manufacturer: Burlington Medical, LLC. Recall notifications issued by letter. For instructions and updates, refer to the FDA recall notice and Burlington Medical communications.
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