Burlington Medical, LLC: Burlington Medical, Vest

Recall number

Z-1754-2026

Recalling firm

Burlington Medical, LLC

Product

Burlington Medical, Vest

Status

Open, Classified

Initiated

2026-02-11

Posted

2026-04-02

Terminated

not on file

Reason

Potential for attenuation degradation over time, decreasing the lifespan.

Root cause

Process change control

Action

Burlington Medical notified consignees on about 02/11/2026 via "URGENT - FIELD SAFETY NOTICE (FSN)" letter. Consignees were instructed to ensure all users of the specific Burlington Medical radiation protection garments made aware of this Recall Notice, review inventory for affected units, arrange for the return of those affected units for proper disposal, and complete and return the Recall Response Form. Consignees were also instructed to notify appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold.

Quantity

15,438 units

Distribution

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.

Lot, serial or model codes

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 ), 00840331259964 (VESTC8-R8PVEST-XLM ), 00840331259971 (VESTC8-R8PVEST-XSF ), 00840331259988 (VESTC8-R8PVEST-XSM ), 00840331269680 (VESTT18-R8PVEST-LF ), 00840331269697 (VESTT18-R8PVEST-LM ), 00840331269680 (VESTT18-R8PVEST-MF ), 00840331269697 (VESTT18-R8PVEST-MM ), 00840331269680 (VESTT18-R8PVEST-PLUS ), 00840331269680 (VESTT18-R8PVEST-SF ), 00840331269697 (VESTT18-R8PVEST-SM ), 00840331269680 (VESTT18-R8PVEST-XLF ), 00840331269697 (VESTT18-R8PVEST-XLM ), 00840331269697 (VESTT18-R8PVEST-XSM ), 00840331269680 (VESTT28-R8PVEST-2XF ), 00840331269697 (VESTT28-R8PVEST-2XM ), 00840331269680 (VESTT28-R8PVEST-3XF ), 00840331269697 (VESTT28-R8PVEST-3XM ), 00840331269680 (VESTT28-R8PVEST-4XF ), 00840331269697 (VESTT28-R8PVEST-4XM ), 00840331269680 (VESTT28-R8PVEST-5XF ), 00840331269697 (VESTT28-R8PVEST-5XM ), 00840331269680 (VESTT38-R8PVEST-6XF ), 00840331269697 (VESTT38-R8PVEST-6XM ), 00840331269680 (VESTT38-R8PVEST-7XF ), 00840331269697 (VESTT38-R8PVEST-7XM ), 00840331269680 (VESTT38-R8PVEST-8XF ), 00840331269697 (VESTT38-R8PVEST-8XM ), None (IVESTC8-R8PVEST-LFR ), None (IVESTC8-R8PVEST-MFL ), None (IVESTC8-R8PVEST-MFR ), None (IVESTC8-R8PVEST-MML ), None (IVESTC8-R8PVEST-MMR ), None (IVESTC8-R8PVEST-SFR ), None (IVESTC8-R8PVEST-XSFR ), None (IVESTC8-R8PVEST-2XFR ), None (IVESTC8-R8PVEST-LML ), None (IVESTC8-R8PVEST-LMXL ), None (IVESTC8-R8PVEST-MFS ), None (IVESTC8-R8PVEST-SFL ), None (IVESTC8-R8PVEST-SFS ), None (IVESTC8-R8PVEST-XLFL ), None (IVESTC8-R8PVEST-XLMR ). 5. Model Number: R8QVEST; UDI-DI (Product Code): 00840331260076 (QVESTC18-R8QVEST-LF ), 00840331260083 (QVESTC18-R8QVEST-MF ), None (QVESTC18-R8QVEST-PLUS ), 00840331260106 (QVESTC18-R8QVEST-SF ), 00840331260113 (QVESTC18-R8QVEST-XLF ), 00840331260007 (QVESTC28-R8QVEST-2XF ), 00840331269802 (QVESTT18-R8QVEST-LF ), 00840331269802 (QVESTT18-R8QVEST-MF ), 00840331269802 (QVESTT18-R8QVEST-PLUS ), 00840331269802 (QVESTT18-R8QVEST-SF ), 00840331269802 (QVESTT18-R8QVEST-XLF ), 00840331269802 (QVESTT28-R8QVEST-2XF ), 00840331269802 (QVESTT28-R8QVEST-3XF ), 00840331269802 (QVESTT28-R8QVEST-4XF ), 00840331269802 (QVESTT28-R8QVEST-5XF ), 00840331269802 (QVESTT38-R8QVEST-8XF ), None (IQVESTC8-R8QVEST-SFR ), 00840331260120 (QVESTC18-R8QVEST-XSF ), None (IQVESTC8-R8QVEST-MFR). 6. Model Number: R8VEST; UDI-DI (Product Code): 00840331261752 (VESTC18-R8VEST-2XF ), 00840331261769 (VESTC18-R8VEST-2XM ), 00840331261776 (VESTC18-R8VEST-3XF ), 00840331261783 (VESTC18-R8VEST-3XM ), 00840331261790 (VESTC8-R8VEST-LF ), 00840331261806 (VESTC8-R8VEST-LM ), 00840331261813 (VESTC8-R8VEST-MF ), 00840331261820 (VESTC8-R8VEST-MM ), 00840331261837 (VESTC8-R8VEST-PLUS ), 00840331261844 (VESTC8-R8VEST-SF ), 00840331261851 (VESTC8-R8VEST-SM ), 00840331261868 (VESTC8-R8VEST-XLF ), 00840331261875 (VESTC8-R8VEST-XLM ), 00840331261882 (VESTC8-R8VEST-XSF ), 00840331261899 (VESTC8-R8VEST-XSM ), 00840331261790 (VESTS8-R8VEST-LF ), 00840331261806 (VESTS8-R8VEST-LM ), 00840331261813 (VESTS8-R8VEST-MF ), 00840331261820 (VESTS8-R8VEST-MM ), 00840331261837 (VESTS8-R8VEST-PLUS ), 00840331261844 (VESTS8-R8VEST-SF ), 00840331261851 (VESTS8-R8VEST-SM ), 00840331261868 (VESTS8-R8VEST-XLF ), 00840331261875 (VESTS8-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-LF ), 00840331269635 (VESTT18-R8VEST-LM ), 00840331269628 (VESTT18-R8VEST-MF ), 00840331269635 (VESTT18-R8VEST-MM ), 00840331269628 (VESTT18-R8VEST-PLUS ), 00840331269628 (VESTT18-R8VEST-SF ), 00840331269635 (VESTT18-R8VEST-SM ), 00840331269628 (VESTT18-R8VEST-XLF ), 00840331269635 (VESTT18-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-XSF ), 00840331269635 (VESTT18-R8VEST-XSM ), 00840331269628 (VESTT28-R8VEST-2XF ), 00840331269635 (VESTT28-R8VEST-2XM ), 00840331269628 (VESTT28-R8VEST-3XF ), 00840331269635 (VESTT28-R8VEST-3XM ), 00840331269628 (VESTT28-R8VEST-4XF ), 00840331269635 (VESTT28-R8VEST-4XM ), 00840331269628 (VESTT28-R8VEST-5XF ), 00840331269635 (VESTT28-R8VEST-5XM ), 00840331269628 (VESTT38-R8VEST-6XF ), 00840331269635 (VESTT38-R8VEST-6XM ), 00840331269628 (VESTT38-R8VEST-7XF ), 00840331269635 (VESTT38-R8VEST-7XM ), 00840331269628 (VESTT38-R8VEST-8XF ), 00840331269635 (VESTT38-R8VEST-8XM ), None (IVESTC8-R8VEST-LFR ), None (IVESTC8-R8VEST-LMR ), None (IVESTC8-R8VEST-MMR ), None (IVESTC8-R8VEST-SMS ), None (IVESTC8-R8VEST-MFR ), None (IVESTC8-R8VEST-SFR), None (IVESTC8-R8VEST-LML ), None (IVESTC8-R8VEST-SMR ). 7. Model Number: R8ZVEST; UDI-DI (Product Code): 00840331262063 (ZVESTC18-R8ZVEST-LM), 00840331262087 (ZVESTC18-R8ZVEST-MM), 00840331262087 (ZVESTC18-R8ZVEST-SF), 00840331262148 (ZVESTC18-R8ZVEST-XSF), 00840331269840 (ZVESTT18-R8ZVEST-LM), 00840331269833 (ZVESTT18-R8ZVEST-PLUS), 00840331269840 (ZVESTT28-R8ZVEST-2XM), 00840331269833 (ZVESTT28-R8ZVEST-3XF), None (IZVESTC8-R8ZVEST-LFR). 8. Model Number: S8FVEST; UDI-DI (Product Code): 00840331263275 (VESTC18-S8FVEST-2XF ), 00840331263305 (VESTC18-S8FVEST-3XM ), 00840331263312 (VESTC8-S8FVEST-LF ), 00840331263329 (VESTC8-S8FVEST-LM ), 00840331263336 (VESTC8-S8FVEST-MF ), 00840331263343 (VESTC8-S8FVEST-MM ), 00840331263350 (VESTC8-S8FVEST-PLUS ), 00840331263367 (VESTC8-S8FVEST-SF ), 00840331263374 (VESTC8-S8FVEST-SM ), 00840331263381 (VESTC8-S8FVEST-XLF ), 00840331263398 (VESTC8-S8FVEST-XLM ), 00840331269765 (VESTT18-S8FVEST-LF ), 00840331269772 (VESTT18-S8FVEST-LM ), 00840331269765 (VESTT18-S8FVEST-MF ), 00840331269772 (VESTT18-S8FVEST-MM ), 00840331269765 (VESTT18-S8FVEST-PLUS ), 00840331269765 (VESTT18-S8FVEST-SF ), 00840331269772 (VESTT18-S8FVEST-SM ), 00840331269765 (VESTT18-S8FVEST-XLF ), 00840331269772 (VESTT18-S8FVEST-XLM ), 00840331269772 (VESTT28-S8FVEST-2XM ), 00840331269765 (VESTT28-S8FVEST-3XF ), 00840331269772 (VESTT28-S8FVEST-3XM ), 00840331269765 (VESTT28-S8FVEST-4XF ), 00840331269772 (VESTT28-S8FVEST-4XM ), 00840331269765 (VESTT28-S8FVEST-5XF ), 00840331269772 (VESTT28-S8FVEST-5XM ), 00840331269765 (VESTT38-S8FVEST-6XF ), 00840331269772 (VESTT38-S8FVEST-6XM ), 00840331269765 (VESTT38-S8FVEST-7XF ), 00840331269765 (VESTT38-S8FVEST-8XF ). 9. Model Number: S8PVEST; UDI-DI (Product Code): 00840331263596 (VESTC18-S8PVEST-2XF ), 00840331263602 (VESTC18-S8PVEST-2XM ), 00840331263633 (VESTC8-S8PVEST-LF ), 00840331263640 (VESTC8-S8PVEST-LM ), 00840331263657 (VESTC8-S8PVEST-MF ), 00840331263664 (VESTC8-S8PVEST-MM ), 00840331263671 (VESTC8-S8PVEST-PLUS ), 00840331263688 (VESTC8-S8PVEST-SF ), 00840331263695 (VESTC8-S8PVEST-SM ), 00840331263701 (VESTC8-S8PVEST-XLF ), 00840331263718 (VESTC8-S8PVEST-XLM ), 00840331269703 (VESTT18-S8PVEST-LF ), 00840331269710 (VESTT18-S8PVEST-LM ), 00840331269703 (VESTT18-S8PVEST-MF ), 00840331269710 (VESTT18-S8PVEST-MM ), 00840331269703 (VESTT18-S8PVEST-PLUS ), 00840331269703 (VESTT18-S8PVEST-SF ), 00840331269710 (VESTT18-S8PVEST-SM ), 00840331269703 (VESTT18-S8PVEST-XLF ), 00840331269710 (VESTT18-S8PVEST-XLM ), 00840331269710 (VESTT18-S8PVEST-XSM ), 00840331269703 (VESTT28-S8PVEST-2XF ), 00840331269710 (VESTT28-S8PVEST-2XM ), 00840331269703 (VESTT28-S8PVEST-3XF ), 00840331269710 (VESTT28-S8PVEST-3XM ), 00840331269703 (VESTT28-S8PVEST-4XF ), 00840331269710 (VESTT28-S8PVEST-4XM ), 00840331269703 (VESTT28-S8PVEST-5XF ), 00840331269710 (VESTT28-S8PVEST-5XM ), 00840331269703 (VESTT38-S8PVEST-6XF ), 00840331269710 (VESTT38-S8PVEST-6XM ), 00840331269703 (VESTT38-S8PVEST-7XF ), 00840331269710 (VESTT38-S8PVEST-7XM ), 00840331269703 (VESTT38-S8PVEST-8XF ), 00840331269710 (VESTT38-S8PVEST-8XM ). 10. Model Number: S8QVEST; UDI-DI (Product Code): 00840331263794 (QVESTC18-S8QVEST-LF ), 00840331263800 (QVESTC18-S8QVEST-MF ), 00840331263817 (QVESTC18-S8QVEST-PLUS ), 00840331263824 (QVESTC18-S8QVEST-SF ), 00840331263831 (QVESTC18-S8QVEST-XLF ), 00840331269819 (QVESTT18-S8QVEST-LF ), 00840331269819 (QVESTT18-S8QVEST-MF ), 00840331269819 (QVESTT18-S8QVEST-PLUS ), 00840331269819 (QVESTT18-S8QVEST-XLF ), 00840331269819 (QVESTT28-S8QVEST-2XF ), 00840331269819 (QVESTT28-S8QVEST-3XF ), 00840331269819 (QVESTT28-S8QVEST-4XF ), 00840331269819 (QVESTT28-S8QVEST-5XF ), 00840331269819 (QVESTT38-S8QVEST-6XF ), 00840331269819 (QVESTT38-S8QVEST-7XF ). 11. Model Number: S8VEST; UDI-DI (Product Code): 00840331265477 (VESTC18-S8VEST-2XF ), 00840331265484 (VESTC18-S8VEST-2XM ), 00840331265491 (VESTC18-S8VEST-3XF ), 00840331265514 (VESTC8-S8VEST-LF ), 00840331265521 (VESTC8-S8VEST-LM ), 00840331265538 (VESTC8-S8VEST-MF ), 00840331265545 (VESTC8-S8VEST-MM ), 00840331265552 (VESTC8-S8VEST-PLUS ), 00840331265569 (VESTC8-S8VEST-SF ), 00840331265576 (VESTC8-S8VEST-SM ), 00840331265583 (VESTC8-S8VEST-XLF ), 00840331265590 (VESTC8-S8VEST-XLM ), 00840331265606 (VESTC8-S8VEST-XSF ), 00840331265613 (VESTC8-S8VEST-XSM ), 00840331265514 (VESTS8-S8VEST-LF ), 00840331265521 (VESTS8-S8VEST-LM ), 00840331265538 (VESTS8-S8VEST-MF ), 00840331265545 (VESTS8-S8VEST-MM ), 00840331265569 (VESTS8-S8VEST-SF ), 00840331265576 (VESTS8-S8VEST-SM ), 00840331265583 (VESTS8-S8VEST-XLF ), 00840331265590 (VESTS8-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-LF ), 00840331269659 (VESTT18-S8VEST-LM ), 00840331269642 (VESTT18-S8VEST-MF ), 00840331269659 (VESTT18-S8VEST-MM ), 00840331269642 (VESTT18-S8VEST-PLUS ), 00840331269642 (VESTT18-S8VEST-SF ), 00840331269659 (VESTT18-S8VEST-SM ), 00840331269642 (VESTT18-S8VEST-XLF ), 00840331269659 (VESTT18-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-XSF ), 00840331269659 (VESTT18-S8VEST-XSM ), 00840331269642 (VESTT28-S8VEST-2XF ), 00840331269659 (VESTT28-S8VEST-2XM ), 00840331269642 (VESTT28-S8VEST-3XF ), 00840331269659 (VESTT28-S8VEST-3XM ), 00840331269642 (VESTT28-S8VEST-4XF ), 00840331269659 (VESTT28-S8VEST-4XM ), 00840331269642 (VESTT28-S8VEST-5XF ), 00840331269659 (VESTT28-S8VEST-5XM ), 00840331269642 (VESTT38-S8VEST-6XF ), 00840331269659 (VESTT38-S8VEST-6XM ), 00840331269642 (VESTT38-S8VEST-7XF ), 00840331269659 (VESTT38-S8VEST-7XM ), 00840331269642 (VESTT38-S8VEST-8XF ), 00840331269659 (VESTT38-S8VEST-8XM ), None (IVESTC8-S8VEST-SMS ), None (IVESTC8-S8VEST-LMR ), None (IVESTC8-S8VEST-MMR ). 12. Model Number: S8ZVEST; UDI-DI (Product Code): 00840331265781 (ZVESTC18-S8ZVEST-LM ), 00840331265804 (ZVESTC18-S8ZVEST-MM ), 00840331269864 (ZVESTT18-S8ZVEST-LF ), 00840331269864 (ZVESTT18-S8ZVEST-PLUS ). 13. Model Number: U8FVEST; UDI-DI (Product Code): 00840331267044 (VESTC8-U8FVEST-LF ), 00840331267051 (VESTC8-U8FVEST-LM ), 00840331267075 (VESTC8-U8FVEST-MM ), 00840331267099 (VESTC8-U8FVEST-SF ), 00840331267105 (VESTC8-U8FVEST-SM ), 00840331267112 (VESTC8-U8FVEST-XLF ), 00840331267136 (VESTC8-U8FVEST-XSF ), 00840331269796 (VESTT18-U8FVEST-LM ), 00840331269789 (VESTT18-U8FVEST-PLUS ), 00840331269789 (VESTT18-U8FVEST-XLF ), 00840331269796 (VESTT28-U8FVEST-2XM ), 00840331269789 (VESTT28-U8FVEST-3XF ), 00840331269796 (VESTT28-U8FVEST-3XM ), 00840331269789 (VESTT38-U8FVEST-6XF ), None (IVESTC8-U8FVEST-LML ), None (IVESTC8-U8FVEST-LMR ), None (IVESTC8-U8FVEST-MFR ), None (IVESTC8-U8FVEST-MMR ), None (IVESTC8-U8FVEST-SFR ), None (IVESTC8-U8FVEST-XLML ), None (IVESTC8-U8FVEST-XLMR ). 14. Model Number: U8PVEST; UDI-DI (Product Code): 00840331267013 (VESTC18-U8PVEST-2XM ), 00840331267365 (VESTC8-U8PVEST-LF ), 00840331267372 (VESTC8-U8PVEST-LM ), 00840331267389 (VESTC8-U8PVEST-MF ), 00840331267396 (VESTC8-U8PVEST-MM ), 00840331267402 (VESTC8-U8PVEST-PLUS ), 00840331267419 (VESTC8-U8PVEST-SF ), 00840331267433 (VESTC8-U8PVEST-XLF ), 00840331267440 (VESTC8-U8PVEST-XLM ), 00840331267464 (VESTC8-U8PVEST-XSM ), 00840331269727 (VESTT18-U8PVEST-LF ), 00840331269734 (VESTT18-U8PVEST-LM ), 00840331269727 (VESTT18-U8PVEST-MF ), 00840331269734 (VESTT18-U8PVEST-MM ), 00840331269727 (VESTT18-U8PVEST-PLUS ), 00840331269727 (VESTT18-U8PVEST-SF ), 00840331269734 (VESTT18-U8PVEST-SM ), 00840331269727 (VESTT18-U8PVEST-XLF ), 00840331269734 (VESTT18-U8PVEST-XLM ), 00840331269734 (VESTT18-U8PVEST-XSM ), 00840331269727 (VESTT28-U8PVEST-2XF ), 00840331269734 (VESTT28-U8PVEST-2XM ), 00840331269727 (VESTT28-U8PVEST-3XF ), 00840331269734 (VESTT28-U8PVEST-3XM ), 00840331269734 (VESTT28-U8PVEST-4XF ), 00840331269727 (VESTT28-U8PVEST-4XF ), 00840331269734 (VESTT28-U8PVEST-4XM ), 00840331269727 (VESTT28-U8PVEST-5XF ), 00840331269734 (VESTT28-U8PVEST-5XM ), 00840331269727 (VESTT38-U8PVEST-6XF ), None (IVESTC8-U8PVEST-2XMR ), None (IVESTC8-U8PVEST-LMR ), None (IVESTC8-U8PVEST-MFR ), None (IVESTC8-U8PVEST-MMR ), None (IVESTC8-U8PVEST-SFR ), None (IVESTC8-U8PVEST-SMR ). 15. Model Number: U8QVEST; UDI-DI (Product Code): 00840331267556 (QVESTC18-U8QVEST-LF ), 00840331267563 (QVESTC18-U8QVEST-MF ), 00840331267594 (QVESTC18-U8QVEST-XLF ), 00840331267525 (QVESTC28-U8QVEST-3XF ), 00840331269826 (QVESTT18-U8QVEST-LF ), 00840331269826 (QVESTT18-U8QVEST-PLUS ), 00840331269826 (QVESTT28-U8QVEST-3XF ), 00840331296136 (QVESTT38-U8QVEST-8XF ), None (IQVESTC8-U8QVEST-LFR ). 16. Model Number: U8VEST; UDI-DI (Product Code): 00840331269215 (VESTC18-U8VEST-2XF ), 00840331269222 (VESTC18-U8VEST-2XM ), 00840331269253 (VESTC8-U8VEST-LF ), 00840331269260 (VESTC8-U8VEST-LM ), 00840331269277 (VESTC8-U8VEST-MF ), 00840331269284 (VESTC8-U8VEST-MM ), 00840331269291 (VESTC8-U8VEST-PLUS ), 00840331269307 (VESTC8-U8VEST-SF ), 00840331269314 (VESTC8-U8VEST-SM ), 00840331269321 (VESTC8-U8VEST-XLF ), 00840331269338 (VESTC8-U8VEST-XLM ), 00840331269352 (VESTC8-U8VEST-XSM ), 00840331269260 (VESTS8-U8VEST-LM ), 00840331269277 (VESTS8-U8VEST-MF ), 00840331269666 (VESTT18-U8VEST-LF ), 00840331269673 (VESTT18-U8VEST-LM ), 00840331269666 (VESTT18-U8VEST-MF ), 00840331269673 (VESTT18-U8VEST-MM ), 00840331269666 (VESTT18-U8VEST-PLUS ), 00840331269666 (VESTT18-U8VEST-SF ), 00840331269673 (VESTT18-U8VEST-SM ), 00840331269666 (VESTT18-U8VEST-XLF ), 00840331269673 (VESTT18-U8VEST-XLM ), 00840331269673 (VESTT18-U8VEST-XSM ), 00840331269666 (VESTT28-U8VEST-2XF ), 00840331269673 (VESTT28-U8VEST-2XM ), 00840331269666 (VESTT28-U8VEST-3XF ), 00840331269673 (VESTT28-U8VEST-3XM ), 00840331269666 (VESTT28-U8VEST-4XF ), 00840331269673 (VESTT28-U8VEST-4XM ), 00840331269666 (VESTT28-U8VEST-5XF ), 00840331269673 (VESTT28-U8VEST-5XM ), 00840331269666 (VESTT38-U8VEST-6XF ), 00840331269673 (VESTT38-U8VEST-6XM ), 00840331269666 (VESTT38-U8VEST-7XF ), 00840331269666 (VESTT38-U8VEST-7XM ), 00840331269666 (VESTT38-U8VEST-8XF ), 00840331269673 (VESTT38-U8VEST-8XM ), None (IVESTC8-U8VEST-2XMR ), None (IVESTC8-U8VEST-LMR ), None (IVESTC8-U8VEST-MMR ), None (IVESTC8-U8VEST-SFR ), None (IVESTC8-U8VEST-SMR ), None (IVESTC8-U8VEST-XLMR ), None (IVESTC8-U8VEST-XSFR ). 17. Model Number: U8ZVEST; UDI-DI (Product Code): 00840331269536 (ZVESTC18-U8ZVEST-MF ), 00840331269543 (ZVESTC18-U8ZVEST-MM ), 00840331269901 (ZVESTT28-U8ZVEST-5XM ).

510(k) numbers

not on file

PMA numbers

not on file

Product code

IWO

Firm FEI

1000120804

Firm city

Newport News

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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