Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 29, 2020
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 t
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medivators, Inc. recalled Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes fo… - a moderate-severity action.
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes fo… was recalled by Medivators, Inc. in April 29, 2020. Reason: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedure…. Check the official notice for the remedy. Verify recall #Z-1776-2020 with the FDA Devices before acting.
The recall
Medivators, Inc. issued this moderate-severity FDA Devices recall-Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedure….
- Moderate
- severity level
- 54K units
- affected scope
- Class II
- classification
- April 29, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1776-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1776-2020) was formally reported on April 29, 2020, with the manufacturer initiating the action on October 9, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Medivators, Inc. is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 53,790 units total.
The documented reason for this recall is: 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 r… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Australia, England.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
53,790 units total
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1776-2020 |
| Date reported | April 29, 2020 |
| Date initiated | October 9, 2019 |
| Recalling firm | Medivators, Inc. |
| Firm location | Plymouth, MN |
| Affected scope | 53,790 units total |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, England. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1776-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medivators, Inc.. Units affected: 53,790 units total.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1776-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, England..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1776-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 29, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.