Steris Recalls AMSCO 5000 Series Washer/Disinfector Units Due to Software Defect
Steris Corporation is recalling 68 AMSCO 5000 Series Washer/Disinfector units because a software defect may prevent the intended cleaning cycle from processing, potentially leading to inadequate disinfection.
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 inadequate disinfection of medical devices, which poses a potential for harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Steris Corporation is recalling 68 units of the AMSCO 5000 Series Washer/Disinfector Model # 5052. The recall was initiated due to a software defect that may cause the system to fail to process the originally intended cycle.
This malfunction could result in damage to the medical devices and instruments processed in the washer/disinfector or create a potential for inadequate cleaning or disinfection. The affected units were distributed to 28 US states and seven foreign countries, including Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
Healthcare facilities and other users of these devices should stop using the affected units and contact Steris Corporation for further instructions on the recall. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- AMSCO 5000 Series Washer/Disinfector Model # 5052
- Manufacturer
- Steris Corporation
- Affected units
- 68
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.
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