Reported Jul 6, 2016 · Terminated
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access…
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?
- Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs
- tissues and subsystemsEsophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
- Lot codes and dates
Model #'s EG-3630UEG-3630UREG-3670URKEG-3830UTEG-3870UTKFG-34UXFG-36UX and FG-38UX
- Amount recalled
- 819 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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