The Recall Desk
HighFDA (Devices)·Z-2119-2019·Announced 2019-08-07

Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

Burlington Medical is recalling 210 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.

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: The recall involves a risk-of-harm product where the hazard is theoretical (potential for long-term health conditions) and no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Burlington Medical, LLC is recalling 210 units of Thyroid Collar, Magnetic Closure, Product Number TS5. The affected part numbers are RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, and SLTS5-R. These products were distributed nationwide in the United States and to Korea and Thailand.

The recall is being issued 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.

Healthcare workers who use these products to protect against scatter radiation during fluoroscopic and radiographic procedures should stop using the affected units. Users should check their serial numbers against the list provided by the FDA and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedure
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
210

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

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Same hazard · radiation exposure

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