Richard Wolf GmbH
FDA Regulatory Profile
Richard Wolf GmbH has 10 FDA recalls, 4 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-1753-2025 · Class II · Apr 9, 2025
- Latest inspection
- Oct 20, 2022 · OAI
- Latest 510(k)
- Oct 11, 1996
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 10 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 4 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1753-2025 | Class II | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy… | Apr 9, 2025 |
| Z-1424-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 | Mar 24, 2023 |
| Z-1422-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 | Mar 24, 2023 |
| Z-1425-2023 | Class II | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 | Mar 24, 2023 |
| Z-1423-2023 | Class II | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 | Mar 24, 2023 |
| Z-2246-2021 | Class II | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | Jun 25, 2021 |
| Z-2706-2020 | Class II | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the… | Jun 5, 2020 |
| Z-0804-2019 | Class II | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to… | Oct 17, 2018 |
| Z-1868-2018 | Class II | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery. | Mar 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… | Jul 24, 2017 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3002808001 | Knittlingen, Germany | 4 | Oct 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K962799 | MINIATURE LAPAROSCOPE SET (MINI LAP) | Oct 11, 1996 |