Reported Aug 3, 2016 · Terminated
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper…
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 Product UsageIntended 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-29VEE-1540EE-1580KEG-1540EG-1580KEG-1840EG-2540EG-2940EG-3840TEG-3831TEG-3870TKEG-1870KEG-2470KEG-2530EG-2730KEG-2731EG-2770KEG-290KPEG-2930KEG-2931EG-2931KEG-2970KEG-3430ZEG-3470KEG-3470ZKVSB-3430KEG-1690KEG-2490KEG-2790IEG-2790KEG27-I10EG-2990IEG-2990KEG29-I10EG-3490K and EG-3890TK
- Amount recalled
- 10,074 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
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.
Free recall alerts
Get alerted about new Pentax Medical Company recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.