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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Wrap aprons are used in healthcare settings to protect staff and patients during procedures. Burlington Medical produced a line of wraps using Xenolite 800 attenuation material.
Attenuation degradation over time can shorten the apron’s lifespan, potentially compromising protective performance during use.
This recall is not described as part of a broader industry pattern in the provided information.
The recall affects 5,198 units distributed worldwide. There are no reported injuries or incidents to date, but device degradation could impact safety in clinical environments.
Refer to the FDA recall page and Burlington Medical's official communications for model and date code details.
No specific refund or replacement timeline is provided. Consumers should await manufacturer instructions, with updates posted by FDA.
Keep the recall notice, purchase records, model numbers, date codes, and all correspondence with Burlington Medical for your records.
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,
No injuries or incidents have been reported.
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