Reported Jul 29, 2015 · Terminated

Non Sterile Subassembly

Covidien LLC

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

Is this the product you have?

Non Sterile Subassembly

21 of 21 products

Products covered by this recall
Model / numberProduct as published
SA1008Non Sterile Subassembly: Catalog Number/Description
SA-7457-RSTERILE SUBASSEMBLY SA2008
SA2042SA2042
SA2049SUBASSEMBLY NS SA2049
SA2074SA2074
SA2075NON STERILE SUBASSEMBLY SA2075
SA2109NON STERILE SUBASSEMBLY SA2109
SA2119NON STERILE SUBASSY SA2119
SA2120NON STERILE SUBASSY SA2120
SA2122STERILE SUBASSY SA2122
SRM800SA2185
SA2199SA2199
SA3011SA3011
SA3013NON STERILE SUBASSY SA3013
SA3018NON STERILE SUBASSY SA3018
SA3040NON STERILE SUBASSY SA3040
SA3060SA3060
SA3068SUBASSEMBLY SA3068
SA3069NON STERILE SUBASSY SA3069
SA3071NON STERILE SUBASSY SA3071
Lot codes and dates
  • Lot number begins 508xxxx or lower
Amount recalled
385486

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Devon Light Gloves contain splits or holes compromising the sterility

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

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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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 28, 2017 · Data as of Sep 19, 5:22 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.