RegWardenFDA facility compliance records
Facility

HealthTronics, LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2022: 1 inspections1’12’13’14’15’16’17’18’19’20’211’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Lithotriptor, Extracorporeal Shock-Wave, Urological
    Product code LNS (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5990

Recalls & enforcement

  • Class IITerminated2012-12-20
    The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

FDA inspections (1)

  • NAI2022-05-13
    No 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. “HealthTronics, LLC (FEI 3005655081) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005655081-healthtronics-llc/

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