Medivators EndoGator recall
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus…
Why was Medivators EndoGator recalled?
Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # / Case UDI#s: 430358 / 2067796406530322060110430358, 429884 / 2067796406530322060110429884, 428806 / 2067796406530322070110428806, 430568 / 2067796406530322060110430568, 431254 / 2067796406530322070110431254, 431455 / 2067796406530322070110431455, 431603 / 2067796406530322070110431603, 431834 / 2067796406530322070110431834, 431985 / 2067796406530322070110431985, 431973 / 2067796406530322070110431973, 432922 / 2067796406530322070110432922, 432108 / 2067796406530322070110432108, 432921 / 2067796406530322070110432921, 433116 / 2067796406530322070110433116, 433115 / 2067796406530322080110433115.
- Product
- Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus…
- Recalling firm
- Medivators, Inc.
- Quantity
- 53,790 units total
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)