FDANovember 27, 2024device
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
trokamed
UPCs
04251303810926
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.2024-11-27
- FDASheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.2024-11-27
- FDASheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.2024-11-27
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →