Anspach Effort 45 Degree Contra Angle Attachment Recall for Missing Service Interval
The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments 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, but the hazard is a documentation error (missing service interval) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity involving labeling or documentation issues.
Plain-English summary
The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments used in pneumatic systems. The recall involves 5 units distributed worldwide, including the United States (specifically HI and DC), Puerto Rico, Guam, and Japan.
The reason for the recall is that the supplied Directions for Use (DFU) did not contain a recommended service interval. This omission could potentially affect the maintenance schedule for the device.
Affected units are identified by serial numbers shipped to customers prior to 09/27/2016, DFU 18-0030, and Part No. ORANGE-45. Users should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 45 degree Contra Angle Attachment Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 5
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 18-0030
- Part No. ORANGE-45.
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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