CLASS I ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology recalled
Trokamed is recalling Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology, distributed in Pennsylvania. The recall was initiated on 27 Nov 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0713-2025
- FDA event ID
- 95770
- Recalling firm
- Trokamed, Geisingen
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Nov 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 27 Nov 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +44 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Where it was distributed
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF: WA2PS20S; UDI-DI: 04251303810926; Lot Numbers: 154125
Where was it sold?
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95770This product is part of a recall event; the main page for the event is Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology recalled | Trokamed | Other | PA | |
| CLASS I | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology recalled | Trokamed | Other | PA | |
| CLASS I | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology recalled | Trokamed | Other | PA |
More recalls from Trokamed
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology recalled | Trokamed | Other | PA |
| Device | CLASS I | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology recalled | Trokamed | Other | PA |
| Device | CLASS I | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology recalled | Trokamed | Other | PA |
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| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
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