FDA DevicesClass II
Burlington Medical, Vest
Published: April 8, 2026Recall ID: Z-1754-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Product Description & Identification
Burlington Medical, Vest
Additional Source Details
| Field | Value |
|---|---|
| City | Newport News |
| State | VA |
| Event id | 98415 |
| Address 1 | 3 Elmhurst St |
| Address 2 | Suite 112 |
| Code info | 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 (VEST... [TRUNCATED] |
| Postal code | 23603-1137 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 15,438 units |
| Reason for recall | Potential for attenuation degradation over time, decreasing the lifespan. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260211 |
| Initial firm notification | Letter |
| Center classification date | 20260402 |
Overview
- Recalling FirmBurlington Medical, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.