Reported May 3, 2023 · Ongoing

VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS

Covidien LP

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 LP · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Lot codes and dates
  • UDI-DI10884521784024
  • Serial Numbers

    145 of 145 codes

    • C21RAE0063
    • C21RAE0064
    • C21RAE0065
    • C21RAE0072
    • C21RAE0074
    • C21RAE0032
    • C21RAE0033
    • C21RAE0035
    • C21RAE0036
    • C21RAE0037
    • C21RAE0039
    • C21RAE0054
    • C21RAE0055
    • C21RAE0062
    • C21RAE0073
    • C21RAE0075
    • C21RAH0001
    • C21RAH0002
    • C21RAH0003
    • C21RAH0004
    • C21RAH0005
    • C21RAE0051
    • C21RAE0052
    • C21RAE0053
    • C21RAK0024
    • C21RAK0025
    • C21RAK0026
    • C21RAE0044
    • C21RAE0045
    • C21RAH0012
    • C21RAH0017
    • C21RAH0018
    • C21RAH0019
    • C21RAH0020
    • C21RAK0001
    • C21RAK0002
    • C21RAK0003
    • C21RAK0004
    • C21RAK0005
    • C21RAK0007
    • C21RAK0012
    • C21RAK0013
    • C21RAK0014
    • C21RAH0006
    • C21RAH0007
    • C21RAH0008
    • C21RAH0009
    • C21RAH0010
    • C21RAH0011
    • C21RAK0006
    • C21RAK0010
    • C21RAK0011
    • C21RAG0006
    • C21RAG0007
    • C21RAG0008
    • C21RAG0009
    • C21RAG0010
    • C21RAG0011
    • C21RAG0012
    • C21RAG0013
Amount recalled
145 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • NC

Why it was recalled

There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 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.