Reported Dec 28, 2016 · Terminated

Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and…

Medtronic

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: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Covidien
  • Clearify Visualization System Item Code21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Lot codes and dates
  • Lots beginning with
    • P4J
    • P4K
    • P4L
    • P4M
    • P5A
    • P5B
    • P5C
    • P5D
    • P5E
    • P5F
    • P5G
    • P5H
    • P5J
    • P5K
    • P5L
    • P5M
    • P6A
    • P6B
    • P6C
    • P6D and lots P6E0016GX
    • P6E0049GX
    • P6E0050GX
    • P6E0051GX
    • P6E0052GX
    • P6E0163GX
    • P6E0164GX
    • P6E0212GX
Amount recalled
1,293,169 systems

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

Product sterility is compromised due to breach of the sterile barrier

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 8, 2018 · Data as of Sep 19, 6:02 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.