Device recall: Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is…
Class II FDA enforcement event 82403. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Medrobotics Corporation started this device recall on 25 Jan 2019. The firm address in the FDA record is in Raynham, MA. FDA put the recall in Class II. FDA event 82403 has 2 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 11 Dec 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Medrobotics Corporation, Raynham, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1191-2019 | Obturator (long cone), Part number 25162 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… | 35 | Class II | Terminated | 24 Apr 2019 |
| Z-1192-2019 | 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… | 24 | Class II | Terminated | 24 Apr 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1191-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82403. https://recallregister.com/fda/ii/82403/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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.
- What quantity of product is in FDA event 82403?
- The event has 2 product records. The first record gives this quantity:
35
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.