openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
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.
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
These labels are deterministic app interpretations, not FDA categories.
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
Code information
Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
