Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices 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 explicitly states the issue is non-compliance with Quality System requirements without reporting any illnesses, injuries, or deaths. Per the rubric, when no harm is reported and the hazard is not explicitly high-risk (like a structural defect or pathogen), the score is capped at 3. Given the lack of reported harm and the nature of the quality system issue, it fits the 'Moderate' category for a voluntary precautionary or minor compliance recall.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The specific product identified is the ANSPACH REF SP-5001-00 20 degree Angle Driver (MA-D20) - Custom, which is intended to be used with Anspach Systems. The device is classified as Rx Only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
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. The specific unit identified has Part Number SP-5001-00 and Serial Number 200252. Consumers should contact the manufacturer for further instructions.
The recalled product
- Product
- ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***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: SP-5001-00
- Serial Number: 200252
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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