Anspach Custom Pneumatic Motor Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 16 custom pneumatic motor 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 a manufacturing quality system non-compliance without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling 16 units of their Anspach Custom Devices. The specific product is the Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal, which is intended to be used with Anspach Systems. These devices are prescription-only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The affected units 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 recall involves specific part and serial numbers. Part Number: 98-0034. Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304. Consumers should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Pneumatic Motor
- Affected units
- 16
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 (14)
- Part Number: 98-0034
- Serial Numbers: C25302189205
- C26302224202
- C25302189204
- C25302067902
- C26302224204
- C27302202503
- C28302328702
- C25302127005
- C25302141301
- C25302189201
- C28302328705
- C25302127003
- C25302141304.
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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