Reported Sep 22, 2021 · Ongoing
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel…
Pentax of America Inc
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 of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument
- Channel and a Water Jet Channel ModelsEC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument
- Channels and a Water Jet Channel ModelEC-3890TLK
- Lot codes and dates
- All devices distributed by Pentax in the US between April 2014 and May 2021
- Amount recalled
- 28849 units Total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
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 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.