RegWardenFDA facility compliance records
Facility

LEONHARD LANG GMBH

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2019: 1 inspections1’14’15’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Automated External Defibrillators (Non-Wearable)
    Product code MKJ (opens in a new tab) · Class III · Cardiovascular · 21 CFR 870.5310

Recalls & enforcement

  • Class ITerminated2014-12-03
    The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy o…

FDA inspections (1)

  • VAI2019-07-24
    Voluntary Action Indicated · Project Evaluation: 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. “LEONHARD LANG GMBH (FEI 6736) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/6736-leonhard-lang-gmbh/

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