Burlington Medical Thyroid Shield Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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 →Frequently Asked Questions
Common questions about this FDA recall.