Washer disinfectors recalled because a wire may shift causing internal arcing
Steris is recalling 22 AMSCO 7053HP Washer/Disinfectors because a wire connected to the electrical box may shift out of position, which may result in electrical arcing inside the unit.
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: Scored 2 because the record states the arcing remains internal to the unit with no risk of shock to users and reports no harm.
Plain-English summary
The AMSCO 7053HP Washer/Disinfector from Steris Corporation is being recalled. The device is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments.
A wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. The firm states that the electrical arcing remains internal within the unit, with no risk of shock to users.
The record lists 22 units, carrying UDIs 00724995176662, 00724995176679 and 00724995176655, with serial numbers of distributed units listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Arizona, Colorado, Florida, Georgia, Illinois and Kentucky among other states. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Steris's instructions.
The recalled product
- Product
- Deep-brand Premium Select Surti Papdi Whole Net Wt. 12 oz. (340g) KEEP FROZEN
- Manufacturer
- CHETAK NEW YORK LLC
- Hazard
- electrical-arcing
- loose-wire
- reprocessing
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 (3)
- Lot: 24363
- 25011
- 25046
Distribution
Distribution scope not specified by the agency.
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