Facility

RICHARD WOLF GMBH

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

Key facts

7recalls · worst Class II

2inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002808001
Establishment type	Manufacture Medical Device
Location	PFORZHEIMER STR. 32 KNITTLINGEN Baden-Wurttemberg, DE 75438
Registration status	Active · expires 2026
Parent company	RICHARD WOLF GMBH (owner-operator 8010049)

Activity by year

Recalls (7)
Inspections (2)

Devices registered here (1)

Headlamp, Operating, Battery-Operated
Product code HPP (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.4335

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.

FDA inspections (2)

OAI2022-10-20
Official Action Indicated · Compliance: Devices
VAI2019-09-10
Voluntary Action Indicated · Radiation Control and Health Safety Act

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.

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. “RICHARD WOLF GMBH (FEI 3002808001) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808001-richard-wolf-gmbh/

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