Reported May 15, 2013 · Terminated

Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in…

Stryker Endoscopy

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: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400

Is this the product you have?

  • Stryker Irrigator Reusable Tips2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery
Lot codes and dates
  • Manufacturer Part Number250-070-473
Amount recalled
147,921 - all sizes

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

7 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.

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 Sep 24, 2013 · Data as of Sep 19, 6:17 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.