Trokamed GmbH
Trokamed GmbH appears in FDA public data with 4 recalls — including 4 Class I (most serious) —, 4 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0716-2025, Class I) was initiated on November 27, 2024. Its most recent 510(k) clearance was granted on July 30, 2021.
Summary
- Total Recalls
- 4 (4 Class I)
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0716-2025 | Class I | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. | November 27, 2024 |
| Z-0715-2025 | Class I | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. | November 27, 2024 |
| Z-0713-2025 | Class I | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. | November 27, 2024 |
| Z-0714-2025 | Class I | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. | November 27, 2024 |