Medical DeviceAug 12, 2026
WASPLab recall — FDA Z-2854-2026
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Class IIFDA: OngoingCopan WASP
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMay 28, 2025
Copan WASP PhenoMATRIX recall — FDA Z-1812-2025
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the…
Class IIFDA: OngoingCopan WASP
Understanding this recall history
This page summarizes recall records in which the official source identifies Copan WASP as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.