- Recalling firm
- Burlington Medical, LLC
- Reason for recall
- Potential for attenuation degradation over time, decreasing the lifespan.
- Affected products (lot / model / serial)
- All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8PVEST; UDI-DI (Product Code): 00840331297652 (VESTC18-C8PVEST-2XM ), 00840331297652 (VESTC8-C8PVEST-LF ), 00840331297652 (VESTC8-C8PVEST-LM ), 00840331297652 (VESTC8-C8PVEST-MF ), 00840331297652 (VESTC8-C8PVEST-MM ), 00840331297652 (VESTC8-C8PVEST-SF ), 00840331297652 (VESTC8-C8PVEST-SM ), 00840331297652 (VESTC8-C8PVEST-XLM ), 00840331297652 (VESTT18-C8PVEST-LF ), 00840331297652 (VESTT18-C8PVEST-LM ), 00840331297652 (VESTT18-C8PVEST-MM ), 00840331297652 (VESTT18-C8PVEST-PLUS ), 00840331297652 (VESTT18-C8PVEST-SM ), 00840331297652 (VESTT28-C8PVEST-3XM ), 00840331297652 (VESTT28-C8PVEST-4XM ), 00840331297652 (VESTT28-C8PVEST-5XM ). 2. Model Number: C8VEST; UDI-DI (Product Code): 00840331297645 (VESTC18-C8VEST-2XM ), 00840331297645 (VESTC8-C8VEST-LF ), 00840331297645 (VESTC8-C8VEST-LM ), 00840331297645 (VESTC8-C8VEST-MF ), 00840331297645 (VESTC8-C8VEST-MM ), 00840331297645 (VESTC8-C8VEST-PLUS ), 00840331297645 (VESTC8-C8VEST-SF ), 00840331297645 (VESTC8-C8VEST-SM ), 00840331297645 (VESTC8-C8VEST-XLF ), 00840331297645 (VESTC8-C8VEST-XLM ), 00840331297645 (VESTC8-C8VEST-XSF ), 00840331297645 (VESTT18-C8VEST-LM ), 00840331297645 (VESTT18-C8VEST-MM ), 00840331297645 (VESTT18-C8VEST-SM ), 00840331297645 (VESTT18-C8VEST-XLM ), 00840331297645 (VESTT18-C8VEST-XSM ), 00840331297645 (VESTT28-C8VEST-2XM ), 00840331297645 (VESTT28-C8VEST-4XF ). 3. Model Number: R8FVEST; UDI-DI (Product Code): 00840331259520 (VESTC18-R8FVEST-2XF ), 00840331259537 (VESTC18-R8FVEST-2XM ), 00840331259551 (VESTC18-R8FVEST-3XM ), 00840331259568 (VESTC8-R8FVEST-LF ), 00840331259575 (VESTC8-R8FVEST-LM ), 00840331259582 (VESTC8-R8FVEST-MF ), 00840331259599 (VESTC8-R8FVEST-MM ), 00840331259605 (VESTC8-R8FVEST-PLUS ), 00840331259612 (VESTC8-R8FVEST-SF ), 00840331259629 (VESTC8-R8FVEST-SM ), 00840331259636 (VESTC8-R8FVEST-XLF ), 00840331259643 (VESTC8-R8FVEST-XLM ), 00840331259650 (VESTC8-R8FVEST-XSF ), 00840331269741 (VESTT18-R8FVEST-LF ), 00840331269758 (VESTT18-R8FVEST-LM ), 00840331269741 (VESTT18-R8FVEST-MF ), 00840331269758 (VESTT18-R8FVEST-MM ), 00840331269741 (VESTT18-R8FVEST-PLUS ), 00840331269741 (VESTT18-R8FVEST-SF ), 00840331269758 (VESTT18-R8FVEST-SM ), 00840331269741 (VESTT18-R8FVEST-XLF ), 00840331269758 (VESTT18-R8FVEST-XLM ), 00840331269758 (VESTT18-R8FVEST-XSM ), 00840331269741 (VESTT28-R8FVEST-2XF ), 00840331269758 (VESTT28-R8FVEST-2XM ), 00840331269741 (VESTT28-R8FVEST-3XF ), 00840331269758 (VESTT28-R8FVEST-3XM ), 00840331269741 (VESTT28-R8FVEST-4XF ), 00840331269758 (VESTT28-R8FVEST-4XM ), 00840331269741 (VESTT28-R8FVEST-5XF ), 00840331269758 (VESTT28-R8FVEST-5XM ), 00840331269741 (VESTT38-R8FVEST-6XF ), 00840331269758 (VESTT38-R8FVEST-6XM ), 00840331269741 (VESTT38-R8FVEST-8XF ), 00840331269758 (VESTT38-R8FVEST-8XM ), None (IVESTC8-R8FVEST-MFR ), None (IVESTC8-R8FVEST-MML ), None (IVESTC8-R8FVEST-LFL ), None (IVESTC8-R8FVEST-LFR ), None (IVESTC8-R8FVEST-LML ), None (IVESTC8-R8FVEST-MMR ), None (IVESTC8-R8FVEST-PLUSL ), None (IVESTC8-R8FVEST-SFR ), None (IVESTC8-R8FVEST-SFS ), None (IVESTC8-R8FVEST-SMR ), None (IVESTC8-R8FVEST-SMS ), None (IVESTC8-R8FVEST-XLML ), None (IVESTC8-R8FVEST-XSFS ), None (IVESTC8-R8FVEST-MMXL ), None (IVESTC8-R8FVEST-XLMXL ), None (IVESTC8-R8FVEST-LMR ), None (IVESTC8-R8FVEST-XSFR ), None (IVESTC8-R8FVEST-XSMR ). 4. Model Number: R8PVEST; UDI-DI (Product Code): None (IVESTC8-R8PVEST-LMR ), None (IVESTC8-R8PVEST-SMR ), 00840331259841 (VESTC18-R8PVEST-2XF ), 00840331259858 (VESTC18-R8PVEST-2XM ), 00840331259865 (VESTC18-R8PVEST-3XF ), 00840331259872 (VESTC18-R8PVEST-3XM ), 00840331259889 (VESTC8-R8PVEST-LF ), 00840331259896 (VESTC8-R8PVEST-LM ), 00840331259902 (VESTC8-R8PVEST-MF ), 00840331259919 (VESTC8-R8PVEST-MM ), 00840331259926 (VESTC8-R8PVEST-PLUS ), 00840331259933 (VESTC8-R8PVEST-SF ), 00840331259940 (VESTC8-R8PVEST-SM ), 00840331259957 (VESTC8-R8PVEST-XLF ), 008403
- Units affected
- 15,438 units
- Distribution pattern
- Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
- Firm location
- Newport News, VA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1754-2026
- Recall initiated
- February 11, 2026
- FDA classification date
- April 2, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98415
- Last updated on HTM Vibe
- July 24, 2026