Anspach Custom MDA Tube Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Custom MDA Tubes 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 hospitalizations, injuries, or illnesses. The hazard is related to manufacturing consistency rather than a specific acute safety defect like fire or shock, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom MDA Tubes, specifically those with Part Number 98-0025 and Serial Number 2000220. These devices are intended for use with Anspach Systems and the MA-D20 Attachment.
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 adverse health consequences associated with this recall.
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. Users should contact the manufacturer for further instructions on how to proceed with the recall.
The recalled product
- Product
- ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- 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: 98-0025
- Serial Number: 2000220
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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