Z-1192-2019Class II

Obturator (shortcone), Part number 26114

Name: Z-1192-2019 Obturator (shortcone), Part number 26114
Creator: Medrobotics Corporation
Published: 2019-01-25
License: https://open.fda.gov/license/

Medrobotics Corporation / initiated 2019-01-25 / Terminated / root cause: manufacturing process

FDA source

Medrobotics Corporation began a recall of Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System... on 2019-01-25. FDA classified it as Class II and gives the reason as "The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1192-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-25
Posted: 2019-04-17
Terminated: 2020-12-11
Recalling firm: Medrobotics Corporation
Product: Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 25, 2019, the firm issued an Urgent Voluntary Medical Device Recall notification letter to its customers. The letter informed customers of the potential for the handle of the obturator to detach with the cone remaining in the patient's rectum. Patients were asked to take the following actions: 1. Immediately check your inventory and quarantine all Obturators that you have on hand to prevent their further use. Note: An Obturator may be located in the same sterilization tray as the Flex Rectoscope. 2. Please immediately complete the attached Acknowledgement form -- even if you have no Obturators -and return the form it to Medrobotics by fax: +1-508-823-1703 or by email [email protected]. 3. Ensure relevant staff members -- including clinicians, OR staff, engineers, and product returns staff -- are informed of this recall. 4. If you have supplied any Obturators to any other organization, please advise that organization of this recall and notify Med robotics of that organization's name, address, and contact person so that we may contact them immediately. Please contact Med robotics Customer Service at 1 +508-692-6104 or at [email protected] if you have any questions or need additional information.
Quantity in commerce: 24
Distribution: Worldwide Distribution - US Nationwide in the states of CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.
Product codes and lots: lots 19419-01, 19669-06, 19684-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1192-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1191-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17
Z-1192-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-17

Product code FDF

K162330Class IIFlex Robotic System and Flex Colorectal DriveMedrobotics Corporation / cleared 2017-05-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)