Anspach Compact Speed Reducer Recalled for Missing Service Interval Information
The Anspach Effort, Inc. is recalling 128 Compact Speed Reducer units because the supplied directions for use did not contain a recommended service interval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 corresponds to a moderate severity level. The hazard is a documentation issue (missing service interval) rather than a direct physical defect causing immediate injury.
Plain-English summary
The Anspach Effort, Inc. is recalling 128 units of the Compact Speed Reducer, 60:1 Black Max. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units were distributed worldwide, including US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan. The recall covers all serial numbers shipped to customers prior to 09/27/2016, identified by DFU 18-0097 and Part No. CSR60BM.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Compact Speed Reducer, 60:1 Black Max
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Speed Reducer
- Hazard
- Affected units
- 128
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 (3)
- All serial numbers shipped to customers prior to 09/27/2016
- DFU 18-0097
- Part No. CSR60BM.
Distribution
Part of a larger recall action
This product is one of 103 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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