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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Covidien LP: 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.

Agency Publication Date: April 26, 2023
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Affected Products

Product: 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

Product: 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

Product: VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS

UDI-DI: 10884521784062; Serial Numbers: C21RXG0005

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92004
Status: Active
Manufacturer: Covidien LP
Manufactured In: United States
Units Affected: 3 products (145 units; 51 units; 1 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.