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.
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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Model numbers include C8F17 and the R8601 family, with multiple UDI-DI codes listed. Distributed worldwide, including US nationwide and international markets (Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, Vietnam). Manufactured with Xenolite 800 attenuation material from 2025-01-16 to 2026-01-21. Quantity: 14,323 units. Sold through worldwide distribution to healthcare facilities.
Attenuation degradation over time may reduce shielding effectiveness. The risk is inadequate protection during radiologic procedures, potentially increasing patient or staff radiation exposure.
No injuries or incidents have been reported.
1. Stop using the product. 2. Do not use during radiologic procedures until cleared. 3. Review whether your aprons are affected by checking model numbers and date of manufacture. 4. Contact Burlington Medical, LLC or your healthcare provider for instructions on remedies. 5. Follow the manufacturer’s recall instructions and await further guidance on replacement or repair.
Phone: Unknown Website: Unknown Hours: Unknown Reference: FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1756-2026
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