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ZVEST

BURLINGTON MEDICAL, LLC · Model R8ZVEST-5XM · UDI-DI 00840331261981

IWO

510(k) clearances

Adverse events

Recalls

Facilities

Description

R8ZVEST-5XM, MALE (Custom ZVEST: Vest with Zipper Closure .5MM XENOLITE 800, 5XM)

Recalls

Date	Firm	Reason
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.
2026-02-11	Burlington Medical, LLC	Potential for attenuation degradation over time, decreasing the lifespan.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.