Burlington Medical Thyroid Shield Recall
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Burlington Medical, LLC is recalling 41,962 units of its Thyroid Shields due to potential attenuation degradation over time, which could decrease their lifespan.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 16, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
Burlington Medical Thyroid Shield Recall
What Happened
The recall is due to the potential for attenuation degradation over time, decreasing the lifespan of the Thyroid Shields.
Which Products Are Affected
The affected products are Burlington Medical Thyroid Shields manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026. A total of 41,962 units are involved, distributed nationwide in the US and internationally to countries including Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Specific models include: R8COPEH with UDI-DI 00840331299052, R8TSBBB with UDI-DI 00840331260311, R8TSBBN with UDI-DI 00840331260328, and many others as detailed in the recall notice, such as R8TSBBR, R8TSBBT, up to U8TSVMR.
What You Should Do
Consumers should contact Burlington Medical, LLC as per the initial firm notification via letter for instructions on the recall.
Why This Matters
This recall involves medical devices used for radiation protection, which could impact user safety if the shields fail to provide adequate attenuation.
Source
FDA Recall Number: Z-1753-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,258 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.