Copan Italia FDA Recalls

4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible witClass IIOct 29, 2025Treatment reagent functionality in respiratory specimens liq	Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.	Class IIDevices	Oct 29, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulkClass IIOct 29, 2025Treatment reagent functionality in respiratory specimens flu	Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.	Class IIDevices	Oct 29, 2025
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx OnlyClass IIMay 2, 2025Swabs for specimen collection may be prone to breakage durin	Swabs for specimen collection may be prone to breakage during product usage.	Class IIDevices	May 2, 2025
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Class IIJul 9, 2021A sterility assurance level of 10-6 cannot be guaranteed due	A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at	Class IIDevices	Jul 9, 2021