The Recall Desk

FDA (Devices) recall action 84109

Medivators, Inc. recalled 7 products on 2020-04-29

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2020-04-29
Critical
0
Units
376,530

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • HighFDA (Devices)··2020-04-29

    Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo SmartCap Tubing because a manufacturing anomaly may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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 or water leaks during endoscopic procedures.

    Product
    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, 160/2
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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 a
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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 endoscopic procedures.

    Product
    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 pu
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    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 a
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    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 alo
    Category
    Distribution
    0 states