Anspach eMax 2 Modified Hand Control Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling six eMax 2 Modified 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 injuries, illnesses, or specific hazards, fitting the criteria for a voluntary precautionary recall or minor non-compliance.
Plain-English summary
The Anspach Effort, Inc. is recalling six units of the Anspach eMax 2 Modified Hand Control (Part Number 98-0016). The recall involves specific serial numbers: 200008201, 200008202, 200008203, 200008204, 200008205, and 200008206. These devices are intended to be used with Anspach Systems and are prescription-only products.
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 units.
The affected units were distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers and healthcare providers with these specific serial numbers should contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- ANSPACH***REF 98-0016***eMax 2 Modified 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
- 6
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 (7)
- Part Number: 98-0016
- Serial Numbers: 200008201
- 200008202
- 200008203
- 200008204
- 200008205
- 200008206.
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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