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.
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 2/5 (Moderate).
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 →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSteris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect
FDA (Devices) · 2018-09-12
- ModerateSteris Recalls AMSCO Steam Sterilizers Due to Software Defect
FDA (Devices) · 2015-05-06
- ModerateSteris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues
FDA (Devices) · 2014-01-08
- HighSteris Recalls AMSCO 5000 Series Washer/Disinfector Units Due to Software Defect
FDA (Devices) · 2019-03-20
- HighSteris Eagle 3000 Sterilizer Recall Due to Incorrect Safety Valve
FDA (Devices) · 2019-12-11
- HighSteris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect
FDA (Devices) · 2019-03-20