BELLUS MEDICAL, LLC
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
- Warning letters (1)
Devices registered here (1)
- Powered Microneedle DeviceProduct code QAI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4430
Recalls & enforcement
- Class IITerminated2019-01-18Cosmetic Kit was packaged with a mislabel medical product.
FDA inspections (2)
- NAI2018-07-25No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- OAI2016-03-23Official Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
FDA warning letters (1)
- Warning Letter2016-09-13Warning Letter (opens in a new tab) · Johnson City Tennessee
Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.
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. “BELLUS MEDICAL, LLC (FEI 3010392991) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010392991-bellus-medical-llc/
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