Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
Medivators is recalling Endo SmartCap Tubing kits due to a manufacturing anomaly that may cause inadequate insufflation or water leaks during endoscopic procedures.
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 is classified as FDA Class II. The hazard involves a risk of harm (inadequate insufflation or leaks) during a medical procedure, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Medivators, Inc. is recalling the EndoGator REF 100650 kit, which contains Endo SmartCap Irrigation Tubing for Olympus GI Endoscopes. The recall involves 53,790 units distributed worldwide, including the United States, Australia, and England.
The recall is being issued due to a manufacturing anomaly. This defect may present during medical procedures as inadequate insufflation, the presence of air bubbles inside the tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
The affected product is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. Specific lot numbers and Case UDI numbers are listed in the official recall documentation.
The recalled product
- Product
- Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240…
- Manufacturer
- Medivators, Inc.
- Affected units
- 53,790
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 (12)
- Lot # / Case UDI#s: 429694 / 2067796406529722070110429694
- 429695 / 2067796406529722060110429695
- 430357 / 2067796406529722070110430357
- 430566 / 2067796406529722070110430566
- 432106 / 2067796406529722080110432106
- 431602 / 2067796406529722070110431602
- 431611 / 2067796400000722070110431611
- 431972 / 2067796406529722070110431972
- 432728 / 2067796406529722080110432728
- 431833 / 2067796406529722080110431833
- 432920 / 2067796406529722080110432920
- 432919 / 2067796406529722080110432919.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medivators, Inc. 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 7 products in this recall →Related recalls
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FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
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- HighMedivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
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