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 does not report any illnesses, injuries, or hospitalizations, and the hazard is related to manufacturing consistency rather than a specific acute safety defect like fire or shock.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected products are Anspach Custom Devices, specifically the ANSPACH***MA Attachment, Straight version Custom, which are intended to be used with Anspach Systems. The recall involves 6 units with Part Numbers 98-0005 and 98-0011, and Serial Numbers 200390, 200379, 20030001, 20030002, 20035201, and 20035202.
These devices 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. Consumers should contact The Anspach Effort, Inc. for further instructions regarding the recall.
The recalled product
- Product
- ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 6
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 (8)
- Part Numbers: 98-0005
- 98-0011
- Serial Numbers: 200390
- 200379
- 20030001
- 20030002
- 20035201
- 20035202.
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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