NEW WAVE ENDO
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
Devices registered here (1)
- Instrument, Ligature Passing And Knot TyingProduct code HCF (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800
Recalls & enforcement
- Class IITerminated2020-07-08The plastic housing on the device may fracture
FDA inspections (2)
- VAI2025-10-28Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- VAI2023-02-17Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
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.
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. “NEW WAVE ENDO (FEI 3015209038) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015209038-new-wave-endo/
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