Anspach eMax Hand Control Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling three eMax Hand Control 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 does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing quality issue rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
The Anspach Effort, Inc. is recalling three units of the Anspach eMax Hand Control (Part Number 98-0001). The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices are intended to be used with Anspach Systems and are prescription-only. The specific serial numbers involved in this recall are 20028601 and 20028602.
Distribution of the affected units included the United States (specifically AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, and TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers should contact the recalling firm for further instructions.
The recalled product
- Product
- ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Hand Control
- 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 (3)
- Part Number: 98-0001
- Serial Numbers: 20028601
- 20028602
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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