Steris V-PRO 60 Sterilizer Software Recall to Prevent Expired Sterilant Use
Steris Corporation is recalling 406 V-PRO 60 Low Temperature Sterilization Systems to update software that prevents the use of expired sterilant.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Steris Corporation is recalling 406 units of the V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000). The recall is being conducted to update the sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
The affected units were distributed in 44 U.S. states, Puerto Rico, and numerous international countries. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and users should contact Steris Corporation for instructions on how to obtain the software update. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
- Manufacturer
- Steris Corporation
- Affected units
- 406
Distribution
Related recalls
Same manufacturer · Steris Corporation
See all →- ModerateHarmonyAIR A-Series surgical light heads may show paint delamination
FDA (Devices) · 2026-06-24
- ModerateHarmonyAIR A-Series surgical light intensity control buttons may detach
FDA (Devices) · 2026-06-24
- ModerateALYON surgical light head intensity control buttons may detach
FDA (Devices) · 2026-06-24
- ModerateDisplay adapters recalled after the wrong configuration file was used
FDA (Devices) · 2026-02-18
- CriticalFrozen whole surti papdi recalled after testing positive for Salmonella
FDA (Devices) · 2025-12-17
Same hazard · software defect
See all →- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25