Cook Incorporated medical device recall: Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96848
- Recall initiated
- May 15, 2025
- Classified by FDA
- Jun 16, 2025
- Posted in Enforcement Report
- Jun 25, 2025
- Recalling firm
- Cook Incorporated
- Firm location
- Bloomington, IN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 15, 2025. FDA classified it 32 days later, on Jun 16, 2025. Distribution reported by FDA: Worldwide distribution. Cook Incorporated has 78 recalls in our records.
Recalled products (1)
Z-1902-2025 Class I Ongoing
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).
Codes / lots: 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087962(17)260202(30)5(10)15881668 (box), Lot Number 15881668; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260219(10)15903001 (product), (01)10827002087962(17)260219(30)5(10)15903001 (box), Lot Number 15903001; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260306(10)NS15932463 (product), (01)10827002087962(17)260306(30)5(10)NS15932463 (box), Lot Number NS15932463; 2) HNBR5.0-35-100-P-NS-DAV (RPN) G08699 (GPN), UDI: (01)00827002086999(17)260411(10)16003554 (product), (01)10827002086996(17)260411(30)5(10)16003554 (box), Lot Number 16003554; 3) HNBR5.0-35-100-P-NS-H1 (RPN) G08421 (GPN), UDI: (01)00827002084216(17)260314(10)15948423 (product), (01)10827002084213(17)260314(30)5(10)15948423 (box), Lot Number 15948423; 4)…
Quantity: 26986 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96848
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.