Richard Wolf GmbH

Complete recall history across all FDA and CPSC categories — 10 total recalls

Richard Wolf GmbH appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Richard Wolf GmbH

Date Product Reason Class
Apr 9, 2025 PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acousti... The high voltage capacitor may fail early in the product life cycle after del... Class II
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by a... Class II
Mar 24, 2023 FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by a... Class II
Mar 24, 2023 FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by a... Class II
Mar 24, 2023 FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by a... Class II
Jun 25, 2021 CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 Product labeled as Cutting Electrode may contain BIVAP electrode. Class II
Jun 5, 2020 Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) com... Tube material of a smaller diameter was used. Class II
Oct 17, 2018 Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ... There is a potential deficiency of the TEXAS Bronchoscope Tube product. The ... Class II
Mar 11, 2018 RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endosc... Tube ends may be mixed up. Class II
Jul 24, 2017 Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cart... Punch may have a burr in one section of the joint and when the punch is open,... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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