FDA DevicesClass II
Burlington Medical, Leg Wraps.
Published: April 8, 2026Recall ID: Z-1761-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for attenuation degradation over time, decreasing the lifespan.
Product Description & Identification
Burlington Medical, Leg Wraps.
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: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4). |
| Postal code | 23603-1137 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 103 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.