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.
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 span a range of FKIL and TT variants with C8K303 primary model. Affected units were manufactured with Xenolite 800 attenuation material between 01/16/2025 and 01/21/2026. 15,216 units distributed worldwide. UDI codes and product codes include: 00840331297638 (FKILTC18-C8K303-2XM), FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT
The device carries a risk of attenuation degradation over time, which could reduce its effectiveness and lifespan. This is not a reported injury but represents a potential reduced safety margin for users.
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. Monitor for manufacturer updates and recall notices. 5. Refund or replacement details are to be provided by the recall process.
Phone: Unknown. Website: Unknown. Hours: Unknown. Consumers should contact Burlington Medical, LLC or their healthcare providers for instructions and to obtain recall remedies.
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