Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk
Medrobotics is recalling 24 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 where a component may separate, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medrobotics Corporation is recalling 24 units of the Obturator (shortcone), Part number 26114. This component is part of the Flex Rectoscope, which is an accessory to the Flex Robotic System used for robot-assisted visualization and surgical site access to the anus, rectum, and distal colon in adults.
The recall is being issued because the weld on the obturator may break. If this occurs, the rod may separate from the cone of the long and short cone Obturators.
The affected units were distributed worldwide, including nationwide in the United States in the states of Colorado, District of Columbia, Florida, Illinois, Maryland, Missouri, New York, Oklahoma, Pennsylvania, Texas, and Virginia, as well as in Australia and Italy. The specific lots involved are 19419-01, 19669-06, and 19684-06.
The recalled product
- 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…
- Manufacturer
- Medrobotics Corporation
- Affected units
- 24
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 (3)
- lots 19419-01
- 19669-06
- 19684-06
Distribution
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 →Related recalls
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See all →- HighMedrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk
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