Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections
Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for physical harm (residual metal on skin) but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cochlear Americas Inc. is recalling 288 units of the Cochlear Baha Soft Tissue Gauge 6mm. This reusable instrument is used to ensure soft tissue thickness is equal to or less than 6 mm for use with the Baha Attract hearing system. The affected units were distributed nationwide.
The recall is being conducted due to a possible manufacturing imperfection in the smooth surface of the metal. This defect could potentially leave residual metal on the patient's skin. The affected units are identified by Outer Package Lots COH523440, COH485876, and COH484221, with Device Lot No. 131008.
Healthcare providers and consumers should stop using the affected gauges and contact Cochlear Americas Inc. for further instructions or a replacement.
The recalled product
- Product
- Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
- Manufacturer
- Cochlear Americas Inc.
- Affected units
- 288
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)
- Outer Package Lot COH523440
- COH485876
- and COH484221 with/Device Lot No. 131008
Distribution
Distributed nationwide across the United States.
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