Burlington Medical radiation protection vests may lose attenuation over time
Burlington Medical is recalling protective vests because of the potential for attenuation degradation over time, decreasing the lifespan of the garment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: degraded attenuation reduces the radiation protection the garment is worn to provide, and no injuries are stated.
Plain-English summary
Burlington Medical is recalling its protective vests. About 15,438 units were distributed nationwide in the United States and internationally to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay and Vietnam. The FDA has classified this recall as Class II.
There is potential for attenuation degradation over time, decreasing the lifespan of the product.
Affected product is identified in the FDA enforcement record.
Facilities can identify affected vests by the product details above, and may contact Burlington Medical for further information.
The recalled product
- Product
- Burlington Medical, Vest
- Manufacturer
- Burlington Medical, LLC
- Hazard
- attenuation-degradation
- radiation-exposure
- reduced-lifespan
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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 )
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22