Medivators Endo Smartcap Tubing Recall: Risk of Inadequate Insufflation During Procedures
Medivators recalls Endo Smartcap Endoscope Tubing (REF100145CO2EXTU) due to potential inadequate insufflation, air bubbles, or water leakage during endoscopic procedures. Affected units include specific lot numbers and packaging sizes.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Medivators is recalling Endo Smartcap Endoscope Tubing that may cause inadequate insufflation, air bubbles, or water leakage during endoscopic procedures. This could lead to improper procedure outcomes or complications if the tubing is used without addressing the issue. Read more at govinfonow.com/recall/66854-medivators-endo-smartcap-tubing-recall-risk-of-inadequate-insufflation-during.
Source Summary by GovInfoNow · govinfonow.com/recall/66854-medivators-endo-smartcap-tubing-recall-risk-of-inadequate-insufflation-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1774-2020
Cite this page
“Medivators Endo Smartcap Tubing Recall: Risk of Inadequate Insufflation During Procedures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66854-medivators-endo-smartcap-tubing-recall-risk-of-inadequate-insufflation-during. Based on FDA recall #Z-1774-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2020%22&limit=1).
Why it’s dangerous
The tubing may not provide sufficient air or water during procedures, leading to air bubbles in the tubing, insufficient water to rinse the lens, or water leaking from the air/water valve. This could cause inadequate insufflation, affecting the procedure's effectiveness or safety.
Who’s affected
Endoscopists and medical professionals using Medivators Endo Smartcap Tubing for Olympus endoscopes are affected. Those using the specific lot numbers listed in the recall are at risk.
How to tell if you have this one
Check the packaging for REF100145CO2EXTU, with contents of 1, 10, or 50 units. The tubing is for Olympus 140/240, 160/260, 180/280, or 190/290 Series Endoscopes with Extended CO2 Input. Look for lot numbers 426407, 427516, 428107, or 427865.
- Brand
Medivators- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
| Recall number | Product, codes & lots |
|---|---|
| Z-1772-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - 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.; Lot # / UDI #s: 427416 / 00677964059492208051427416, 427098 / 00677964059492208031427098, 427819 / 00677964059492208071427819, 427154 / 00677964059492208031427154. |
| Z-1773-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - 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.; Lot # / UDI #s: 426399 / 006779640594692207241426399, 426401 / 006779640594692207241426401. |
| Z-1774-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - 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.; Lot # / UDI #s: 426407 / 006779640590942207241426407, 427516 / 006779640590942208051427516, 428107 / 006779640590942208081428107, 427865 / 006779640590942208071427865. |
| Z-1775-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - 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.; Lot # / UDI #s: 427118 / 006779640590872208031427118, 427117 / 006779640590872208031427117, 427116 / 006779640590872208031427116, 428819 / 006779640590872208131428819, 430069 /006779640590872208241430069, 426432 / 006779640590872207251426432, 426431 / 006779640590872207251426431, 426433 / 006779640590872207251426433, 427129 / 006779640590872208031427129, 427505 / 006779640590872208051427505, 427132 / 006779640590872208031427132, 428284 / 006779640590872208111428284, 428110 / 006779640590872208081428110, 427130 / 006779640590872208031427130, 427131 / 006779640590872208031427131, 428821 / 006779640590872208131428821, 428823 / 006779640590872208131428823, 428282 / 006779640590872208111428282, 428576 / 006779640590872208121428576, 427119 / 006779640590872208031427119. |
| Z-1776-2020 | 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 to an endoscope during endoscopic procedures.; 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. |
| Z-1777-2020 | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 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.; 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. |
| Z-1778-2020 | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - 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.; Lot # 1000028736 GTIN: 00677964086045 Use-by date: 210120 |
What to do — step by step
Check Product Lot Numbers
Compare your tubing's lot number to the listed numbers: 426407, 427516, 428107, or 427865.
Contact Manufacturer for Guidance
Reach out to Medivators, Inc. for specific instructions on handling the recalled tubing if you have it.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, England.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1774-2020 (October 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1774-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.