The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1774-2020·Announced 2020-04-29

Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the manufacturing anomaly could affect procedure safety, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medivators, Inc. is recalling Endo Smartcap Endoscope Tubing (REF100145CO2EXTU) due to a manufacturing anomaly. The tubing 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. The affected tubing is packaged as Contents 1, 10, or 50 and is compatible with Olympus 140/240, 160/260, 180/280, and 190/290 Series Endoscopes With Extended CO2 Input.

The manufacturing anomaly may present during procedures as inadequate insufflation, the presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. The recall involves 53,790 units distributed worldwide, including the United States, Australia, and England. Specific lot numbers and UDI numbers are listed in the official recall record.

Healthcare facilities and consumers should stop using the affected tubing and contact Medivators, Inc. for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
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…
Manufacturer
Medivators, Inc.
Category
Medical Device — Endoscope Tubing
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 (4)

  • Lot # / UDI #s: 426407 / 006779640590942207241426407
  • 427516 / 006779640590942208051427516
  • 428107 / 006779640590942208081428107
  • 427865 / 006779640590942208071427865.

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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