The Recall Desk
ModerateFDA (Devices)·Z-1777-2020·Announced 2020-04-29

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, air bubbles, or water leaks during endoscopic procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional defect (manufacturing anomaly) rather than a high-risk pathogen or structural failure, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls without reported harm.

Plain-English summary

Medivators, Inc. is recalling 53,790 units of Endo SmartCap Tubing kits (REF 100651) used with Olympus GI endoscopes. The recall is due to a manufacturing anomaly that may present during 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 products were distributed worldwide, including the United States, Australia, and England. The kits are 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.

Healthcare facilities should stop using the affected lots and contact Medivators for further instructions. Specific lot numbers and case UDI numbers are listed in the official recall notice.

The recalled product

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 AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Ol
Manufacturer
Medivators, Inc.
Category
Medical Device — Endoscopy Accessories
Hazard
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 (15)

  • 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.

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 →

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