Anspach Custom eMax 2 Plus Motor Recalled for Quality System Defects
The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.
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: The recall is classified as FDA Class II. The source text cites non-compliance with Quality System requirements but does not report any illnesses, injuries, or specific functional failures, aligning with the rubric for moderate severity.
Plain-English summary
The Anspach Effort, Inc. is recalling nine units of the Anspach Custom eMax 2 Plus Motor with microMax Disconnect Sleeve. The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The affected devices are identified by Part Number 98-0035 and Serial Numbers B51301262004, B51301262001, and 2000487. These devices are intended to be used with Anspach Systems and are marked as Rx Only.
The 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. The source text does not specify further instructions for consumers or healthcare providers.
The recalled product
- Product
- ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 9
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 (4)
- Part Number: 98-0035
- Serial Numbers: B51301262004
- B51301262001
- 2000487.
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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