Anspach eMax2 Plus Hand Control Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling eMax2 Plus Hand Controls 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, and the source text cites a manufacturing quality system failure without reporting specific injuries, illnesses, or immediate safety hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Devices, specifically the eMax2 Plus Hand Control (Part Number 98-0062, Serial Number E15200088401). The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices are prescription-only (Rx Only) and are intended to be used with Anspach Systems. The distribution pattern includes 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 and healthcare providers should contact The Anspach Effort, Inc. for further instructions regarding the recall and potential replacement or repair of the affected units.
The recalled product
- Product
- ANSPACH***REF-98-0062***Custom Device eMax2 Plus 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
- 1
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: 98-0062
- Serial Number: E15200088401.
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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