Richard Wolf GmbH
FDA Regulatory Profile
Richard Wolf GmbH appears in FDA public data with 10 recalls, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1753-2025, Class II) was initiated on April 9, 2025. Its most recent 510(k) clearance was granted on October 11, 1996.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1753-2025 | Class II | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy d | April 9, 2025 |
| Z-1423-2023 | Class II | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 | March 24, 2023 |
| Z-1425-2023 | Class II | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 | March 24, 2023 |
| Z-1424-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 | March 24, 2023 |
| Z-1422-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 | March 24, 2023 |
| Z-2246-2021 | Class II | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | June 25, 2021 |
| Z-2706-2020 | Class II | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the | June 5, 2020 |
| Z-0804-2019 | Class II | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to | October 17, 2018 |
| Z-1868-2018 | Class II | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery. | March 11, 2018 |
| Z-2897-2018 | Class II | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other n | July 24, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K962799 | MINIATURE LAPAROSCOPE SET (MINI LAP) | October 11, 1996 |