- 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: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).
- Units affected
- 1,489 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-1758-2026
- 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