FDA Medical devices recall ·
1ml of DTT in liquid phase, in PET tube with capture cap… recall
- Recall number
- Z-0942-2026
- Date
- (initiated October 29, 2025)
- Company / brand
- Copan Italia
Via Francesco Perotti 10, 18, Brescia, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 122,850 units US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI:0U020N.A - (01)18053326005036
Distribution
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
States: California Colorado Florida Georgia Minnesota Mississippi New Hampshire New Jersey New York Ohio Pennsylvania Tennessee Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0942-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.