Beacon Tip 5 — Class I medical device recall Z-1902-2025
Ongoing recall by Cook Incorporated, reported 2025-06-25. Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
| Recall number | Z-1902-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2025-05-15 |
| Classified | 2025-06-16 |
| Reported by FDA | 2025-06-25 |
| Quantity | 26,986 units |
| UPC / GTIN / UDI-DI | 00827002084193, 00827002084209, 00827002084216, 00827002084223, 00827002084414, 00827002084421, 00827002084438, 00827002084445, 00827002084476, 00827002084698, 00827002084704, 00827002084711, 00827002085787, 00827002085817, 00827002085831, 00827002085848, 00827002085961, 00827002085978, 00827002086258, 00827002086777, 00827002086999, 00827002087965, 00827002088092, 00827002088498, 00827002093126 and 107 more |
| Lot numbers | 15879274, 15879283, 15879284, 15879285, 15881668, 15881670, 15882844, 15895235, 15895236, 15895237, 15901235, 15901238, 15901240, 15902079, 15903001, 15907353, 15907354, 15907355, 15907358, 15907359, 15908438, 15912384, 15912385, 15912387, 15919325, 15921475, 15921476, 15924172, 15928714, 15928715, 15930790, 15932470, 15932471, 15935929, 15936458, 15936460, 15936461, 15937655, 15937663, 15940018 and 154 more |
Product
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).
Reason for recall
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1902-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.