Anspach Custom Medium Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling four Custom Medium Attachments 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 score.
Plain-English summary
The Anspach Effort, Inc. is recalling four units of the Anspach Custom Medium Attachment, Reference 98-0031, with a 5 mm Extended Tapered Tip. The recall is due to the units not being manufactured consistently with Quality System requirements.
The affected devices are prescription-only and intended for use with Anspach Systems. The four units were distributed worldwide, including to specific states in the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden. The specific serial numbers involved are 200056702, 200030002, 200056701, and 200030001.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the use of these units.
The recalled product
- Product
- ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 4
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 (5)
- Part Number: 98-0031
- Serial Numbers: 200056702
- 200030002
- 200056701
- 200030001.
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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