Anspach Nose Cone Cover Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Nose Cone Covers 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 a manufacturing quality issue without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices, specifically the Nose Cone Cover (Part Number: 98-0024; Serial Number: 2000100). The recall involves 12 units that were distributed worldwide, including to the United States and several international locations.
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 events associated with the use of these devices.
Consumers who possess these devices should contact The Anspach Effort, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 12
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: 98-0024
- Serial Number: 2000100
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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