CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report
of DTT in liquid phase, in PET tube with capture cap, in bulk recalled
Copan Italia is recalling of DTT in liquid phase, in PET tube with capture cap, in bulk, distributed in 14 states. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0943-2026
- FDA event ID
- 97961
- Recalling firm
- Copan Italia, Brescia
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Oct 2025
- FDA classified
- 18 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Oct 2025 | Recall initiated by company | |
| 18 Dec 2025 | Classified by FDA | +50 days |
| 24 Dec 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Product as listed by the FDA
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Where it was distributed
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
CaliforniaColoradoFloridaGeorgiaMinnesotaMississippiNew HampshireNew JerseyNew YorkOhioPennsylvaniaTennesseeTexasUtah
Questions about this recall
Why was it recalled?
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Which lots are affected?
UDI:0U020N.A - (01)18053326005043
Where was it sold?
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97961This product is part of a recall event; the main page for the event is of DTT in liquid phase, in PET tube with capture cap recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | of DTT in liquid phase, in PET tube with capture cap recalled | Copan Italia | Other | 14 states |
More recalls from Copan Italia
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | of DTT in liquid phase, in PET tube with capture cap recalled | Copan Italia | Other | 14 states |
| Device | CLASS II | BD BBL CultureSwab EZ Collection and Transport System recalled | Copan Italia | Device Malfunction | Nationwide |
| Device | CLASS II | Copan FLOQSwabs, Sterile.EO, for drawing clinical samples recalled | Copan Italia | Sterility | Nationwide |
| Device | CLASS III | WASP (Walk Away Specimen Process) recalled by Copan Italia | Copan Italia | Device Malfunction | CA, OR |
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