Anspach Custom Autolube Food Guard Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Autolube Food Guard 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. The hazard is related to manufacturing quality system non-compliance 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 Custom Autolube Food Guard (Part Number: 98-0033; Serial Number: 200055701). The recall is due to the units not being manufactured consistently with Quality System requirements.
The affected 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. The source text does not specify the number of units affected or report any illnesses or injuries associated with the recall.
Consumers and healthcare providers should contact The Anspach Effort, Inc. for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- ANSPACH***REF 98-0033***Custom Autolube Food Guard***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: 98-0033
- Serial Number: 200055701
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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