Anspach eMax2 Console Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling eMax2 Console 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. The hazard is a manufacturing quality system non-compliance without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach eMax2 Console with Irrigation devices. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The recalled devices are identified by Part Number 98-0021 and Serial Numbers A46200000001 and 20042601. The source text indicates a quantity of 2 units were involved in this recall. Distribution was worldwide, including 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 specific actions for consumers or healthcare providers beyond the recall notice itself. No injuries or illnesses are reported in the provided text.
The recalled product
- Product
- ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 2
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: 98-0021
- Serial Numbers: A46200000001
- 20042601
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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