Anspach XMax Motor Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling three XMax Motor units because they were not manufactured consistently with Quality System requirements.
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: The recall is classified as FDA Class II, but the source text explicitly states the issue is a manufacturing inconsistency with Quality System requirements without reporting any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling three units of the Anspach XMax Motor with Custom Hose. The recall is limited to specific units identified by Part Number 98-0042 and Serial Numbers 20069801 and 20069802.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not report any specific injuries, illnesses, or malfunctions associated with these devices.
The affected units were distributed in the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers who possess these specific serial numbers should contact the manufacturer for further instructions.
The recalled product
- Product
- ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 3
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 (2)
- Part Number: 98-0042
- Serial Numbers: 20069801. 20069802.
Distribution
Part of a larger recall action
This product is one of 45 recalled by The Anspach Effort, Inc. 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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