Copan Italia recalls BD BBL CultureSwab EZ Collection and Transport System

Swabs for specimen collection may be prone to breakage during product usage.

On May 2, 2025, Copan Italia Spa issued a Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Copan asked consignees to take the following steps: 1. Trace and dispose of all affected products 2. Disposal must be carried out according to local regulations. Evidence or declaration of Product disposal must be returned in writing 3. This notice should be passed on to all those who need to be aware within your organization. if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter and submit the acknowledgment form.

• FDA enforcement recordOfficial FDA database entry for Z-1937-2025
• FDA 510(k) clearance · K993161The device's official FDA premarket clearance record
• FDA device classification · JTWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Copan ItaliaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.