FDA Medical devices recall ·
BD BBL CultureSwab EZ Collection and Transport System recall
- Recall number
- Z-1937-2025
- Date
- (initiated May 2, 2025)
- Company / brand
- Copan Italia
Via Francesco Perotti 10, 18, Brescia, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 81,600 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Why was it recalled?
Swabs for specimen collection may be prone to breakage during product usage.
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
Lot: 2415377/UDI: 38053326002145
Distribution
US Nationwide distribution in the state of MD.
States: Maryland
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-1937-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.