Reported Jun 8, 2016 · Terminated

Video Duodenoscope

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?

  • Video Duodenoscope
Lot codes and dates
  • 423 of 423 codes

    • A110021
    • A110022
    • A110023
    • A110024
    • A110025
    • A110026
    • A110027
    • A110028
    • A110029
    • A110030
    • A110031
    • A110032
    • A110033
    • A110034
    • A110035
    • A110036
    • A110037
    • A110038
    • A110039
    • A110043
    • A110046
    • A110051
    • A110055
    • A110056
    • A110057
    • A110058
    • A110059
    • A110060
    • A110061
    • A110062
    • A110063
    • A110064
    • A110065
    • A110067
    • A110068
    • A110070
    • A110071
    • A110072
    • A110073
    • A110074
    • A110075
    • A110076
    • A110077
    • A110078
    • A110079
    • A110080
    • A110081
    • A110082
    • A110083
    • A110086
    • A110087
    • A110088
    • A110089
    • A110090
    • A110091
    • A110092
    • A110095
    • A110098
    • A110099
    • A110100
Amount recalled
423 units

Where it was sold

  • Nationwide

Why it was recalled

Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

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.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 6, 2017 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.