Z-1465-2023Class II

VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS

Name: Z-1465-2023 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Creator: Covidien LP
Published: 2023-03-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-03-22 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LP began a recall of VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS on 2023-03-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1465-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-22
Posted: 2023-04-26
Recalling firm: Medtronic, Inc.
Product: VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated March 2023 was sent to customers. Customer Actions: Our records show that your facility has received the impacted product. Medtronic requests that you take the following actions: " Identify and quarantine any used and unused impacted product. Please refer to Attachment A: Impacted Serial Number Lists for a list of affected products. For verifying the respective product and serial number on the device and packaging please refer to Attachment B. " Sterilize all used devices as per your standard decontamination protocol prior to returning used cannulas. Utilization of appropriate personal protective equipment is advisable during decontamination of the device. " Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) " Medtronic Technical Services at 1-800-962-9888, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
Quantity in commerce: 1 units
Distribution: Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Product codes and lots: UDI-DI: 10884521784062; Serial Numbers: C21RXG0005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1465-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-26
Z-1464-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-26
Z-1465-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-26

Product code GCJ

K201805Class IIVersaOne Reusable Positioning Trocar SystemCovidien / cleared 2020-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)