Burlington Medical Recalls Overlap Vests Due to Potential Inadequate Radiation Protection
Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where the protective material may be inadequate, posing a theoretical risk of long-term health conditions like cancer, but no injuries or illnesses have been reported.
Plain-English summary
Burlington Medical, LLC is recalling seven units of the Overlap Vest, Single Item, Product Number FVest. The affected part numbers include REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, and SEFVEST*M. The specific serial numbers for the recalled units are 385688, 387953, 385694, 385696, 387781, 384424, and 382874.
The recall was initiated because the protective material used in the manufacture of these vests could potentially provide inadequate protection for the user. Using the products could expose the user to scatter radiation of varying degrees, depending on variables such as distance, shielding, position, time, and kV. Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
The products were distributed nationwide in the United States and to foreign countries including Korea and Thailand. Users should stop using the affected vests and contact Burlington Medical, LLC for further instructions.
The recalled product
- Product
- Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 7
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 (1)
- Serial Numbers: 385688 387953 385694 385696 387781 384424 382874
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Burlington Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · Burlington Medical, LLC
See all →- HighBurlington Medical kilts may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical kilt blockers may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical BAT coverage may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical leg wraps may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical half aprons may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighBurlington Medical radiation protection vests may lose attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical kilt blockers may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical protective sleeves may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighBurlington Medical leg wraps may lose radiation attenuation over time
FDA (Devices) · 2026-04-08
- HighMWT Materials Recalls Accusorb MRI Leg Wraps Due to Overheating Risk
FDA (Devices) · 2016-01-27
- HighBurlington Medical blockers may lose radiation attenuation over time
FDA (Devices) · 2026-04-08