Steris Recalls AMSCO 3000 Series Washer/Disinfector Units Due to Software Defect
Steris Corporation is recalling 11 AMSCO 3000 Series Washer/Disinfector units because a software defect may prevent intended processing cycles, risking inadequate cleaning or damage to medical instruments.
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 involves a risk-of-harm product (medical device) where inadequate disinfection could lead to patient harm, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Steris Corporation is recalling 11 units of the AMSCO 3000 Series Washer/Disinfector Model # 3052. The recall is due to a software defect that may cause the systems to fail to process the originally intended cycle.
This malfunction could result in damage to the various medical devices and instruments processed in the washer/disinfector, or it could lead to inadequate cleaning or disinfection. The affected units were distributed to 28 U.S. states and seven foreign countries, including Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
Healthcare facilities and users should stop using the affected units and contact Steris Corporation for further instructions. The specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- AMSCO 3000 Series Washer/Disinfector Model # 3052
- Manufacturer
- Steris Corporation
- Affected units
- 11
Distribution
Part of a larger recall action
This product is one of 2 recalled by Steris Corporation 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.
See all 2 products in this recall →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 disinfection
See all →- HighSwabCap disinfecting caps may have an incomplete seal allowing alcohol evaporation
FDA (Devices) · 2025-07-23
- HighOlympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
FDA (Devices) · 2024-12-11
- HighSmiths Medical Tracheal Tube Introducer Recall Due to Inadequate Disinfection
FDA (Devices) · 2024-12-04
- HighTracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk
FDA (Devices) · 2024-12-04
- HighSmiths Medical Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk
FDA (Devices) · 2024-12-04