Anspach Custom 5 cm Extension Bearing Sleeve Recalled for Quality Issues
The Anspach Effort, Inc. is recalling two custom extension bearing sleeves 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving quality system deviations.
Plain-English summary
The Anspach Effort, Inc. is recalling two units of the Anspach Custom 5 cm Extension Bearing Sleeve (Part Number: 98-0023; Serial Number: 2000288). The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The affected devices are intended to be used with Anspach Systems and are available by prescription only. The recall covers two units that 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 specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***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 (2)
- Part Number: 98-0023
- Serial Number: 2000288
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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