United StatesOlympus Toomey Evacuator 30cc with adaptor (Model 188), Toomey Evacuator 50cc with adaptor (Model 188A), Olympus Ellik Evacuator with glass body, male connecting tubing & latex bulb (Model 194), and Olympus glass body for the 194 Ellik Evacuator (Model 190A) are affected; you can recognize them by those model numbers. They were recalled because some sterilization parameters in the instructions for use may not consistently render the devices adequately sterile, and the instructions should no longer be used to sterilize the devices.
What's being recalled
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers. Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers. Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
The hazard
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)