Z-1937-2025Class II

BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

Name: Z-1937-2025 BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Creator: Copan Italia
Published: 2025-05-02
License: https://open.fda.gov/license/

Copan Italia / initiated 2025-05-02 / Open, Classified / root cause: manufacturing process

FDA source

Copan Italia began a recall of BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only on 2025-05-02. FDA classified it as Class II and gives the reason as "Swabs for specimen collection may be prone to breakage during product usage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1937-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-02
Posted: 2025-06-09
Recalling firm: Copan Italia
Product: BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Product code: JTW System, Transport, Aerobic
Reason for recall: Swabs for specimen collection may be prone to breakage during product usage.
Root cause tag: manufacturing process
FDA 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 in commerce: 81,600 units
Distribution: US Nationwide distribution in the state of MD.
Product codes and lots: Lot: 2415377/UDI: 38053326002145

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1937-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09

Product code JTW

K993161Class ICopan Easy-Swab Collection and Transport SystemCopan Diagnostics, Inc. / cleared 1999-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)