The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1191-2019·Announced 2019-04-24

Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device used during surgery that could lead to component separation, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Medrobotics Corporation is recalling 35 units of the Obturator (long cone), Part number 25162. This component is part of the Flex Rectoscope, which is an accessory to the Medrobotics Flex Robotic System intended for robot-assisted visualization and surgical site access to the anus, rectum, and distal colon in adults.

The recall is due to a potential defect where the weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. The affected lots are 18832-17, 19042-07, 19042-01, 19199-01, 19669-05, and 19684-05.

The products were distributed worldwide, including nationwide in the United States in the states of CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA, as well as to Australia and Italy. Users should stop using the affected obturators and contact Medrobotics Corporation for instructions on return or replacement.

The recalled product

Product
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…
Manufacturer
Medrobotics Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • lots 18832-17
  • 19042-07
  • 19042-01
  • 19199-01
  • 18832-17
  • 19669-05
  • 19684-05

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medrobotics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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