RegWardenFDA facility compliance records
Company

RICHARD WOLF GMBH

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2018: 2 recalls; 2020: 1 recalls; 2021: 1 recalls; 2023: 1 recalls; 2025: 1 recalls1201722018201912020120212022120232024120252026
  • Recalls (7)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-04-09
    The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capaci…
  • Class IIOngoing2023-03-24
    Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
  • Class IITerminated2021-06-25
    Product labeled as Cutting Electrode may contain BIVAP electrode.
  • Class IITerminated2020-06-05
    Tube material of a smaller diameter was used.
  • Class IIOngoing2018-10-17
    There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
  • Class IITerminated2018-03-11
    Tube ends may be mixed up.
  • Class IIOngoing2017-07-24
    Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “RICHARD WOLF GMBH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010049-richard-wolf-gmbh/

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