Reported Jul 6, 2016 · Terminated
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract.…
Pentax Medical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax Medical Company · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs
- tissues and subsystemsEsophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations
- Lot codes and dates
Model #'s FG-16VFG-24VFG-29VEG-1540EG-1580KEG1840EG-2540EG-2940EG-3840TEG-3831TEG-3870TKEG-1870KEG-2470KEG-2530EG-2730KEG-2731EG-2770KEG-290KPEG-2930KEG-2931EG-2931KEG-2970KEG-3430ZEG-3470KEG-3470ZKEG-1690KEG-2490KEG-2790IEG-2790KEG27-I10EG-2990IEG-2990KEG29-I10EG-3490K and EG-3890TK
- Amount recalled
- 9,669 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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