AMSCO 7052HP washer disinfectors recalled over a wire that may shift
Steris is recalling 10 AMSCO 7052HP Washer/Disinfectors because a wire connected to the electrical box may shift out of position, which may result in electrical arcing inside the unit.
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: 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 7052HP 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 10 units, carrying UDIs 00724995176587, 00724995176594 and 00724995176570, 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
- AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps…
- Manufacturer
- Steris Corporation
- Affected units
- 10
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 (12)
- Lot Code: UDI:00724995176587
- 00724995176594
- 00724995176570 Serial number of distributed units: 3619625011
- 3621625009
- 3621625012
- 3621925006
- 3621925009
- 3622425006
- 3622725007
- 3623425005
- 3623825002
- 3624525002
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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