Burlington Medical Recalls 310 Full Wrap Vests and Kilts for Radiation Protection Defects
Burlington Medical is recalling 310 two-piece full wrap vests and kilts because the protective material may provide inadequate shielding 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 (radiation shielding) where the hazard is theoretical (potential inadequate protection) and no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Burlington Medical, LLC is recalling 310 units of the 2 pc Full Wrap Vest & Kilt, Product Number VK. The affected products include various part numbers such as ECREVKA, ECREVKB, and REVK*F. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.
The recall was initiated because the protective material used in the manufacture of these products could potentially provide inadequate protection for the user. Use of 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. Healthcare workers and facilities should stop using these products and contact Burlington Medical for instructions on return or replacement.
The recalled product
- Product
- 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 310
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 kilts 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
- Moderate2k Innovations Recalls Volt Resistance Heated Therapy Shoulder Wrap
FDA (Devices) · 2017-04-19
- HighBurlington Medical leg wraps may lose radiation attenuation over time
FDA (Devices) · 2026-04-08