Brescia, Italy
Copan Italia recalls
3 recalls recorded since 2018, most recently on 29 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 October 2025
- Reason
- Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
- Distribution
- US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0942-2026, Z-0943-2026
- 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-Away Specimen Processor for Microbiology) System
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Ongoing Class II Medical devices
- Recall started
- 2 May 2025
- Reason
- Swabs for specimen collection may be prone to breakage during product usage.
- Distribution
- US Nationwide distribution in the state of MD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1937-2025
- BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Terminated Class II Medical devices
- Recall started
- 9 July 2021
- Terminated
- 25 January 2024
- 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.
- Distribution
- US nationwide distribution, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2440-2021
- COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Si
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.