CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report
VersaOne Reusable Positioning Cannula Standard recalled by Covidien
Covidien is recalling VersaOne Reusable Positioning Cannula Standard, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1465-2023
- FDA event ID
- 92004
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 26 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 26 Apr 2023 | Classified by FDA | +35 days |
| 3 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Where it was distributed
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Questions about this recall
Is VersaOne Reusable Positioning Cannula Standard recalled?
Yes. Covidien recalled VersaOne Reusable Positioning Cannula Standard on 22 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1465-2023.
Why was it 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.
Which lots are affected?
UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
Where was it sold?
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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