Recall of Burlington Medical Blockers Due to Attenuation Degradation
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Burlington Medical, LLC is recalling 51 units of their Blockers because of potential attenuation degradation over time, affecting devices manufactured between January 16, 2025, and January 21, 2026.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 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.
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Recall of Burlington Medical Blockers
What Happened
Burlington Medical, LLC has initiated a voluntary recall due to the potential for attenuation degradation over time, which could decrease the lifespan of the devices.
Which Products Are Affected
The affected products are Burlington Medical Blockers, with a total of 51 units manufactured with Xenolite 800 attenuation material from January 16, 2025, to January 21, 2026. The specific models include: 1. Model Number: R8BLOCKER1; UDI-DI: 00840331272895. 2. Model Number: R8BLOCKER2; UDI-DI: 00840331272901. 3. Model Number: R8BLOCKER3; UDI-DI: 00840331272918. 4. Model Number: R8BLOCKER4; UDI-DI: 00840331272932. 5. Model Number: R8BLOCKER5; UDI-DI: 00840331272949. 6. Model Number: R8BLOCKER6; UDI-DI: 00840331272956. 7. Model Number: S8BLOCKER1; UDI-DI: 00840331272963. 8. Model Number: S8BLOCKER2; UDI-DI: 00840331272970. 9. Model Number: S8BLOCKER3; UDI-DI: 00840331272987. 10. Model Number: U8BLOCKER1; UDI-DI: 00840331273038. All serial numbers for these models are affected. The recall number is Z-1764-2026, and distribution was nationwide in the US and internationally to countries including Canada, Australia, and others.
What You Should Do
Consumers with these affected products should contact Burlington Medical, LLC, located at 3 Elmhurst St, Suite 112, Newport News, VA 23603-1137, as the recall was initiated via letter for further instructions on returns or refunds.
Why This Matters
This recall involves 51 units of medical devices that could have reduced effectiveness over time, potentially impacting user safety in various settings across the United States and internationally.
Source
FDA Recall Number: Z-1764-2026
Original source: FDA Official Notice ↗
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