Knittlingen, N/A, Germany
Richard Wolf GmbH recalls
7 recalls recorded since 2018, most recently on 9 April 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)4
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 April 2025
- Reason
- 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 capacitor failure occurs.
- Distribution
- US State: GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1753-2025
- PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Ongoing Class II Medical devices
- Recall started
- 24 March 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates (AE), Argentina (AR), Austria (AT), Belgium (BE), BO, Brazil (BR), Canada (CA), Chile (CL), Czech Republic (CZ), Germany (DE), Denmark (DK), Ecuador (EC), Spain (ES), Finland (FI), France (FR), Greece (GR), Hong Kong (H
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1423-2023, Z-1422-2023, Z-1425-2023, Z-1424-2023
- FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
- FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
- FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
- FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Terminated Class II Medical devices
- Recall started
- 25 June 2021
- Terminated
- 5 January 2024
- Reason
- Product labeled as Cutting Electrode may contain BIVAP electrode.
- Distribution
- US Nationwide Distribution in the states of CA, CO, IN, MA, NH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2246-2021
- CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Terminated Class II Medical devices
- Recall started
- 5 June 2020
- Terminated
- 28 June 2024
- Reason
- Tube material of a smaller diameter was used.
- Distribution
- International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2706-2020
- Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the low
Ongoing Class II Medical devices
- Recall started
- 17 October 2018
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide in the states of PA, MD, NY, and countries of Bangladesh, Canada, China, France, Germany, India, Italy, Jordan, Netherlands, Poland, Russia, Spain, Thailand, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0804-2019
- Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and
Terminated Class II Medical devices
- Recall started
- 11 March 2018
- Terminated
- 9 March 2022
- Reason
- Tube ends may be mixed up.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1868-2018
- RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Ongoing Class II Medical devices
- Recall started
- 24 July 2017
- Reason
- Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
- Distribution
- Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2897-2018
- Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard pu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.