The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2122-2019·Announced 2019-08-07

Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

Burlington Medical is recalling 807 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing long-term health risks.

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 specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Burlington Medical, LLC is recalling 807 units of Thyroid Collar, Buckle Closure, Product Number TS4. The affected products include various part numbers such as RBTS4-R, RBTS4-T2T, and RETS4-R. These devices 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. Using these products may expose users 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 affected units are listed in the official recall record. Healthcare workers and facilities should stop using the affected thyroid collars and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
807

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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