Cook Incorporated: Device Recall
Recall #Z-1902-2025 · 05/15/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1902-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Cook Incorporated
- Status
- Ongoing
- Date Initiated
- 05/15/2025
- Location
- Bloomington, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26986 units
Reason for Recall
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Product Description
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
Distribution Pattern
Worldwide distribution.
Other Recalls by Cook Incorporated
- Class II: Risk 11/26/2025
- Class II: Risk 11/26/2025
- Class II: Risk 11/26/2025
- Class II: Risk 04/17/2025
- Class II: Risk 04/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.