Copan Italia recalls
Copan Italia appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2013-09-11 to 2025-12-24 |
| By agency | FDA Device (5) |
| By classification | Class II (4), Class III (1) |
| By status | ongoing (3), terminated (2) |
| Distribution named in notices | CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, OR, PA, TN, TX, US, UT |
Recalls
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-A…
FDA Device · Class II · 2025-12-24 · Copan Italia
Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. - 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
FDA Device · Class II · 2025-12-24 · Copan Italia
Reason: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. - BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA Device · Class II · 2025-06-18 · Copan Italia
Reason: Swabs for specimen collection may be prone to breakage during product usage. - COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples
FDA Device · Class II · 2021-09-15 · Copan Italia
Reason: A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. - WASP (Walk Away Specimen Process)
FDA Device · Class III · 2013-09-11 · Copan Italia
Reason: The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary f…