FDAFDA · Food and drugs·Recall number Z-1761-2026
Burlington Medical, Leg Wraps.
Published April 8, 2026 · Recall initiated: February 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for attenuation degradation over time, decreasing the lifespan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Burlington Medical, LLC
- Distributor
- 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
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.