Anspach Custom Pneumatic Motor Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text cites Quality System non-compliance without reporting specific injuries or illnesses, aligning with a Moderate severity rating for a voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 45 units of the Anspach Custom XMax Motor, Pneumatic. This medical device is intended to be used with Anspach Systems and is available by prescription only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The affected products include specific part numbers and serial numbers listed in the agency's recall record.
The recalled devices were distributed worldwide, including to the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer or their healthcare provider for instructions on replacement or repair.
The recalled product
- Product
- ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 45
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 (20)
- Part Number: 98-0039
- 98-0040
- 98-0050
- 98-0057
- Serial Numbers: C06301529106
- 200058302
- 200058301
- 200057701
- 200057702
- 200058402
- 200058401
- 200057802
- 200057801
- C05301514406
- C06301529102
- C8301529004
- C08301529002
- C08301529007
- C08301529006
- 200058301. 200069302
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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