CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 recalled
Medivators is recalling Medivators EndoGator, distributed nationwide in the US. The recall was initiated on 9 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1776-2020
- FDA event ID
- 84109
- Recalling firm
- Medivators, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2019
- FDA classified
- 23 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 9 Oct 2019 | Recall initiated by company | |
| 23 Apr 2020 | Classified by FDA | +197 days |
| 29 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: 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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Stores named: Walmart
Questions about this recall
Is Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 recalled?
Yes. Medivators recalled Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 on 9 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-1776-2020.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medivators
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dialysate Concentrate for Hemodialysis-Liquid/Powd recalled | Medivators | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Endo Smartcap Endoscope Tubing recalled by Medivators | Medivators | Sterility | Nationwide |
| Device | CLASS II | Endo Smartcap Endoscope Tubing recalled by Medivators | Medivators | Sterility | Nationwide |
| Device | CLASS II | Endo Smartcap Endoscope Tubing recalled by Medivators | Medivators | Sterility | Nationwide |
| Device | CLASS II | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 recalled | Medivators | Sterility | Nationwide |
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