Trokamed GmbH medical device recall: Sheath
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 95770
- Recall initiated
- Nov 27, 2024
- Classified by FDA
- Jan 10, 2025
- Posted in Enforcement Report
- Jan 22, 2025
- Recalling firm
- Trokamed GmbH
- Firm location
- Geisingen, Germany
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Nov 27, 2024. FDA classified it 44 days later, on Jan 10, 2025. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Recalled products (4)
Z-0713-2025 Class I Ongoing
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Codes / lots: REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125
Quantity: 34 units
Z-0714-2025 Class I Ongoing
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Codes / lots: REF: WA2PS20L; UDI-DI: 04251303810919; Lot Numbers: 154236
Quantity: 42 units
Z-0715-2025 Class I Ongoing
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Codes / lots: REF: WA2PS18S; UDI-DI: 04251303810865; Lot Numbers: 159825
Quantity: 53 units
Z-0716-2025 Class I Ongoing
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Codes / lots: REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
Quantity: 102 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95770
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.