Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect
Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inadequate sterilization) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Steris Corporation is recalling 2,889 units of the AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems. These devices are intended for the terminal sterilization of medical devices in healthcare facilities using VAPROX HC Sterilant.
The recall is due to a potential defect where a punctured cup of sterilant may expire while the system is powered down. Upon power-up, the unit may fail to detect the expired sterilant, allowing subsequent sterilization cycles to be run with expired material. This could result in inadequate sterilization of medical devices.
The affected units were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities should stop using the affected systems and contact Steris Corporation for instructions on how to proceed.
The recalled product
- Product
- AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed
- Manufacturer
- Steris Corporation
- Affected units
- 2,889
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 (6)
- UDI numbers 00724995151973
- 00724995151980
- 00724995151997
- and 00724995152000
- 00724995154677
- 00724995154684
Distribution
Distributed nationwide across the United States.
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 · inadequate sterilization
See all →- HighBD Medical Extension Sets Recalled for Potential Sterilization Defects
FDA (Devices) · 2026-08-19
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighKarl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighMedline procedure kits recalled for surgical masks failing sterilization tests
FDA (Devices) · 2025-02-05
- ModerateKarl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2024-10-02