Anspach eMax2 Foot Pedal Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals 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 cites a manufacturing quality system defect without reporting any specific injuries, illnesses, or immediate safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 21 units of the Anspach eMax2 Lower Profile Foot Pedal. 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 recall covers specific part numbers (98-0002, 98-0004, 98-0007, 98-0030, 98-0036) and serial numbers listed in the agency documentation.
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. Users should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 21
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 (20)
- Part Numbers: 98-0002
- 98-0004
- 98-0007
- 98-0030
- 98-0036
- Serial Numbers: 200245
- 20032601
- 20032602 20032603
- 20032604
- 20032504
- 20032508
- 20032502
- 20032503
- 20032506
- 20032702
- 20032701
- 20032507
- 20032501
- 20032505
- 200027203
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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