CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
BD BBL CultureSwab EZ Collection and Transport System recalled
Copan Italia is recalling BD BBL CultureSwab EZ Collection and Transport System, distributed nationwide in the US. The recall was initiated on 2 May 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-1937-2025
- FDA event ID
- 96807
- Recalling firm
- Copan Italia, Brescia
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2025
- FDA classified
- 9 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 2 May 2025 | Recall initiated by company | |
| 9 Jun 2025 | Classified by FDA | +38 days |
| 18 Jun 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Swabs for specimen collection may be prone to breakage during product usage.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Where it was distributed
US Nationwide distribution in the state of MD.
Questions about this recall
Why was it recalled?
Swabs for specimen collection may be prone to breakage during product usage.
Which lots are affected?
Lot: 2415377/UDI: 38053326002145
Where was it sold?
US Nationwide distribution in the state of MD.
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.
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, in bulk recalled | Copan Italia | Other | 14 states |
| Device | CLASS II | of DTT in liquid phase, in PET tube with capture cap recalled | Copan Italia | Other | 14 states |
| 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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