BD BBL CultureSwab EZ Collection and Transport System, REF… recallZ-1937-2025 · Copan Italia · initiated May 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Copan Italia or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Swabs for specimen collection may be prone to breakage during product usage.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1937-2025
- Status
- Open, Classified
- Initiated by the company
- May 2, 2025
- Posted by the FDA
- Jun 9, 2025
- Recalling firm
- Copan Italia
- Quantity
- 81,600 units
- Product code
- JTW
- FDA submissions
- K993161
- Distribution
- US Nationwide distribution in the state of MD.
Product description
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Code information (models, lots, serial numbers)
Lot: 2415377/UDI: 38053326002145
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BBL™ CultureSwab™ EZ 220144Copan Italia SPA · System, Transport, Aerobic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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