Burlington Medical recalled 5,198 wrap aprons worldwide after attenuation degradation was identified in Xenolite 800 material. The recall covers units manufactured between 01/16/2025 and 01/21/2026. Stop using the aprons immediately and follow the manufacturer’s 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: 5,198 units. Distribution: Worldwide, including the United States and international markets. Manufacture window: 01/16/2025 to 01/21/2026 for units with Xenolite 800 attenuation material. Affected model numbers and UDI codes include C8EURO, C8F111, R8EURO and WRAPC8-C8EURO-LF, WRAPC8-C8EURO-LM, WRAPC8-C8EURO-MF, WRAPC8-C8EURO-MM, WRAPC8-C8EURO-SF, WRAPC8-C8EURO-SM, WRAPC8-C8EURO-XLM, WRAPT18-C8EURO-LF, WRAPT18-C8EURO-LM, WRAPT18-C8EURO-MM, WRAPT18-C8EURO-PLUS, WRAPT18-C8EURO-SM, WRAPC18-R8EURO-2XF, WRAPC18-R8EURO-2XM, WRAPC18-R8EURO-3XF, WRAPC18-R8EURO-3XM, WRAPC8-R8EURO-LF,
The danger is attenuation degradation over time. This can shorten the device lifespan and may lead to unexpected device failure during use in clinical settings.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow recall instructions provided by the manufacturer. 3. Contact Burlington Medical, LLC or your healthcare provider for instructions. 4. Notification method: Letter.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1757-2026
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