Recall Z-1937-2025— Copan Italia

Name: FDA recall Z-1937-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-02

Class II · Ongoing

Class II FDA medical device recall by Copan Italia, initiated 2025-05-02. It names one FDA 510(k) clearance: K993161. Product: BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only. Reason: Swabs for specimen collection may be prone to breakage during product usage..

Recalling firm: Copan Italia
Classification: Class II
Status: Ongoing
Initiated: 2025-05-02
Firm location: Brescia, Italy

510(k) clearances named in this recall

1 on FDA's record

K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.·cleared 1999-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.