Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 23 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing health risks for users.
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 protection) where the hazard is theoretical (potential inadequate protection) and no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Burlington Medical, LLC is recalling 23 units of the Thyroid Collar Oversize, Product Number TS3. The affected part numbers are RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, and RLTS3-T2T. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.
The recall is being issued because the protective material used in the manufacture of these products could potentially provide inadequate protection for the user. Using these 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. Specific serial numbers for the recalled units are listed in the official recall notice. Healthcare workers and facilities should stop using these specific units and contact Burlington Medical for instructions on return or replacement.
The recalled product
- Product
- Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 23
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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