Covidien VersaOne Reusable Cannula 11mm: Metal Shaving Risk
Covidien recalls VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) due to potential metal shavings from welding. Affected units have specific serial numbers. Consumers should check their product details.
Lower-risk 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.
Contact the company
What happened, in plain English
Covidien is recalling VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) because a manufacturing defect may cause metal shavings at the weld point. This could lead to tissue damage during medical procedures if the shavings enter the body. Read more at govinfonow.com/recall/58675-covidien-versaone-reusable-cannula-11mm-metal-shaving-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/58675-covidien-versaone-reusable-cannula-11mm-metal-shaving-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1464-2023
Cite this page
“Covidien VersaOne Reusable Cannula 11mm: Metal Shaving Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58675-covidien-versaone-reusable-cannula-11mm-metal-shaving-risk. Based on FDA recall #Z-1464-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1464-2023%22&limit=1).
Why it’s dangerous
The defect occurs at the weld where the cannula and body components join. Metal shavings (burrs) could potentially enter the body during medical procedures, causing tissue damage or injury.
Who’s affected
Medical professionals using the VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) are most at risk. Patients undergoing procedures with this cannula may be affected if metal shavings cause injury.
How to tell if you have this one
Check for the model number RC11STS on the product. Affected units have specific serial numbers listed in the recall notice, including C20RSL0083 through C21RSK0028.
- Brand
Covidien- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1463-2023 | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS; UDI-DI: 10884521784024; Serial Numbers: 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 C21RAG0014 C21RAG0015 C21RAG0016 C21RAG0017 C21RAG0018 C21RAG0019 C21RAG0020 C21RAH0016 C21RAK0021 C21RAK0022 C21RAK0023 C21RAK0027 C21RAK0028 C21RAB0023 C21RAB0024 C21RAB0025 C21RAE0001 C21RAE0002 C21RAE0003 C21RAE0004 C21RAE0005 C21RAE0006 C21RAE0007 C21RAE0008 C21RAE0009 C21RAK0029 C21RAK0030 C21RAK0031 C21RAK0042 C21RAK0043 C21RAK0044 C21RAK0045 C21RAL0001 C21RAL0002 C21RAL0003 C21RAL0004 C21RAL0005 C21RAL0006 C21RAL0007 C21RAL0008 C21RAL0009 C21RAM0001 C21RAM0002 C21RAM0005 C21RAM0006 C21RAM0042 C21RAM0048 C21RAM0052 C21RAM0053 C21RAM0091 C21RAM0092 C21RAM0093 C21RAM0094 C21RAM0095 C21RAM0096 C21RAM0097 C21RAM0098 C21RAM0099 C21RAM0057 C21RAM0058 C21RAM0060 C21RAM0061 C21RAM0062 C21RAM0063 C21RAM0064 C21RAM0065 C21RAM0066 C21RAM0067 C21RAM0068 C21RAM0069 C21RAK0032 C21RAK0033 C21RAK0034 C21RAK0035 C21RAK0036 C21RAK0037 C21RAK0038 C21RAK0040 C21RAK0041 C21RAM0079 C21RAM0080 C21RAM0081 C21RAM0082 C21RAM0083 C21RAM0084 | 145 units |
| Z-1464-2023 | VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS; UDI-DI: 10884521784048; Serial Numbers: C20RSL0083 C20RSL0085 C20RSL0086 C20RSL0087 C20RSL0088 C20RSL0062 C20RSL0063 C20RSL0071 C20RSL0072 C20RSL0073 C20RSL0074 C20RSL0075 C20RSL0076 C20RSL0070 C21RSJ0012 C20RSL0066 C20RSL0080 C20RSL0095 C20RSL0098 C20RSL0077 C20RSL0078 C20RSL0097 C20RSJ0002 C20RSJ0003 C20RSJ0004 C21RSJ0001 C21RSJ0002 C21RSJ0003 C21RSJ0004 C21RSJ0005 C21RSJ0006 C21RSJ0009 C21RSJ0010 C21RSJ0011 C21RSJ0018 C21RSJ0019 C21RSJ0020 C21RSJ0021 C21RSJ0022 C21RSK0026 C21RSK0027 C21RSK0028 C21RSJ0030 C21RSK0001 C21RSK0002 C21RSJ0013 C21RSJ0014 C21RSJ0015 C21RSJ0016 C21RSK0015 C21RSK0025 | 51 units |
| Z-1465-2023 | VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS; UDI-DI: 10884521784062; Serial Numbers: C21RXG0005 | 1 units |
What to do — step by step
Check Product Details
Review the model number and serial numbers listed in the recall notice to confirm if your VersaOne Reusable Positioning Cannula 11mm Standard is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1464-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1464-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.