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.
What this means for you
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
- Hazard
- sterilization-failure
- inadequate-sterilization
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.
Related recalls
Same category
- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereABIOMED Insertion Kit heart pump accessories introducer sheath leakage
FDA (Devices) · 2026-07-22