Olympus Toomey Evacuator 50cc with Adaptor sterilization recall
Olympus is recalling the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization parameters in the instructions may not reliably render the devices sterile.
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: This is an FDA Class II recall of a medical device where inadequate sterilization creates a risk of harm. No reported illnesses or injuries are stated in the source text, but the failure to adequately sterilize a reusable medical device presents a theoretical high-risk hazard that could lead to infection or contamination.
Plain-English summary
Olympus Corporation of the Americas is recalling the Toomey Evacuator 50cc with Adaptor, Model Number 188A. The recall affects 1,156 units distributed worldwide, including across the US, Canada, Japan, the EU, and Latin America.
Certain sterilization parameters included in the device instructions for use may not consistently render the devices adequately sterile and should no longer be used for sterilization. Users should not follow these parameters when preparing the device for use.
Healthcare facilities and users who have received this device should review the instructions for use and confirm that only appropriate sterilization parameters are being used. Contact Olympus Corporation of the Americas for updated sterilization guidance.
The recalled product
- Product
- Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,156
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 (1)
- Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas 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.
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