Burlington Medical Recalls Radiation Protection Caps Due to Inadequate Shielding
Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from 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 is classified as FDA Class II and involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Burlington Medical, LLC is recalling 49 units of radiation protection caps (Part Numbers CAP1 and CAP2). These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
The recall was initiated because the protective material used in the manufacture of the 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 Korea and Thailand. The recall is classified as Class II by the FDA. Healthcare facilities and users should stop using the affected units and contact Burlington Medical for instructions on return or replacement.
The recalled product
- Product
- Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Manufacturer
- Burlington Medical, LLC
- Hazard
- Affected units
- 49
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.
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