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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The product is a protective vest used to shield patients and healthcare workers from radiation exposure during imaging procedures. It relies on attenuation material to reduce exposure.
Attenuation degradation over time can reduce the vest's shielding effectiveness and lifespan, potentially increasing radiation exposure risk during use.
This recall is not part of a broader industry pattern.
15,438 units distributed worldwide may have reduced protective value. Consumers should stop using affected vests to avoid diminished shielding during imaging.
Recall notices and identifying information are on the FDA enforcement page for Z-1754-2026 and Burlington Medical communications.
The recall notice does not specify a refund or replacement timeline.
Keep recall notices, model numbers, and correspondence as records.
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.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Burlington Medical recalled 15,216 Kilt devices distributed worldwide. The recall follows a potential degradation in attenuation over time that could shorten the device lifespan. Stop using the device immediately and follow the manufacturer’s recall instructions, per the company and FDA notice dated 2026-02-11.
Burlington Medical recalled 51 Blocker devices sold worldwide after a recall notice. The devices may degrade attenuation over time, shortening their lifespan. Stop using the devices immediately and follow the manufacturer’s recall instructions. Contact Burlington Medical, LLC or your healthcare provider for guidance. Distribution is worldwide.
Burlington Medical recalled 14,323 Frontal Aprons sold worldwide after regulators flagged attenuation degradation over time. The aprons use Xenolite 800 shielding material. Healthcare providers should stop using the devices immediately and await instructions from Burlington Medical.
Burlington Medical recalled 1,129 protective sleeves worldwide after determining attenuation degradation over time. The sleeves were manufactured with Xenolite 800 attenuation material between 2025-01-16 and 2026-01-21. The recall affects products distributed in the United States and internationally. Providers and patients should stop using the sleeve and follow recall instructions from the maker.
Burlington Medical recalled 402 Half Aprons sold worldwide after potential attenuation degradation. Attenuation material Xenolite 800 may degrade over time, reducing shielding lifespan. Patients and healthcare providers should stop using the aprons immediately and contact Burlington Medical for recall instructions.
Burlington Medical recalled 94 Kilt Blockers sold worldwide through distributors and healthcare providers. The devices may attenuate over time, shortening their lifespan. Stop using immediately and contact Burlington Medical or your healthcare provider for instructions.
Burlington Medical recalled 1,489 BAT Coverage units worldwide on 2026-02-11 after a design-related issue was identified. The recall targets attenuation material used in the device. The defect could affect the lifespan of the shielding. Healthcare providers and patients should stop using the device and follow manufacturer instructions. The recall is active as of 2026-04-08.
Burlington Medical, LLC recalled 103 leg wrap devices distributed worldwide through multiple retailers. The recall cites attenuation degradation over time that could shorten the devices' lifespan. Healthcare providers and patients should stop using them immediately and follow the manufacturer's recall instructions.