BURLINGTON MEDICAL, LLC
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Shield, Protective, PersonnelProduct code KPY (opens in a new tab) · Class I · Radiology · 21 CFR 892.6500
Recalls & enforcement
- Class IIOngoing2026-02-11Potential for attenuation degradation over time, decreasing the lifespan.
- Class IITerminated2019-06-07The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding…
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “BURLINGTON MEDICAL, LLC (FEI 1000120804) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000120804-burlington-medical-llc/
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