FDA Medical Device Recalls (openFDA)
Copan Italia: BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
- Recall number
- Z-1937-2025
- Recalling firm
- Copan Italia
- Product
- BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
- Status
- Open, Classified
- Initiated
- 2025-05-02
- Posted
- 2025-06-09
- Terminated
- not on file
- Reason
- Swabs for specimen collection may be prone to breakage during product usage.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 81,600 units
- Distribution
- US Nationwide distribution in the state of MD.
- Lot, serial or model codes
- Lot: 2415377/UDI: 38053326002145
- 510(k) numbers
- K993161
- PMA numbers
- not on file
- Product code
- JTW
- Firm FEI
- 3002444944
- Firm city
- Brescia
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28