Reported Jul 6, 2016 · Terminated
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower 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?
- Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs
- tissues and subsystemsLarge Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations
- Lot codes and dates
Model #'s EC-3430LEC-3430LKEC-3470LKEC-380LKPEC-3830LKEC-3930LZEC-3831LEC-3832LEC-3832LKEC-3870LKEC-3870LZKEC-3872LKFC-38LVEC-3830TLKEC-3832TLEC-3870TLKEC-3872TLKEC-3440LEC-3840KEC-2990LIEC-3490LIEC-3490LKEC-3490TLIEC34-I10LEC-3890LIEC-3890LKEC-3890TLK and EC38-I10L
- Amount recalled
- 12,412 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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