The Recall Desk
HighFDA (Devices)·Z-2121-2019·Announced 2019-08-07

Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

Burlington Medical is recalling 2,190 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 (radiation protection) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Burlington Medical, LLC is recalling 2,190 units of Thyroid Collar, Velcro Closure, Product Number TS2. The recall covers various part numbers including RBTS2-R, RETS2-R, and RLTS2PED. 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 the products could potentially provide inadequate protection for the user. Use of 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 Korea and Thailand. No specific illnesses or injuries have been reported in the source text. Healthcare workers using these collars should stop using them and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP Product Usage: Products are designed to protect healthcare workers against scatter (se
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
2,190

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 →

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