Anspach Effort Recalls Otologic Curved Micro Pneumatic Systems
The Anspach Effort, Inc. is recalling 119 Otologic Curved Micro pneumatic systems because the supplied directions for use did not contain a recommended service interval.
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 hazard is a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 119 units of the Otologic Curved Micro pneumatic system. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all serial numbers shipped to customers prior to September 27, 2016, identified by DFU 18-0100 and Part No. OCM.
Consumers and healthcare providers should contact The Anspach Effort, Inc. for instructions on how to proceed with the recall and to obtain updated documentation.
The recalled product
- Product
- Otologic Curved Micro Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Otolaryngology
- Hazard
- Affected units
- 119
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 18-0100
- Part No. OCM.
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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