Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled
Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately 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: FDA Class II medical device recall involving a risk-of-harm (inadequate sterilization of medical devices) with no reported illnesses or injuries stated in the source. This meets the High severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Toomey Evacuator 30cc with Adaptor, Model Number 188, distributed worldwide including the US, Canada, Japan, EU, and Latin America. All lot numbers are affected (UDI-DI: 00821925001053).
Some sterilization parameters included in the instructions for use (IFU) may not consistently render the devices adequately sterile. These parameters should no longer be used to sterilize the devices.
Healthcare facilities and users in possession of affected units should review the sterilization parameters in the product instructions and discontinue use of any parameters that may not provide adequate sterilization. Contact Olympus Corporation of the Americas for guidance on proper sterilization methods and device replacement or return.
The recalled product
- Product
- Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 190
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: 188. UDI-DI: 00821925001053. 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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