Class II — Cook Medical Incorporated
| Recalling firm | COOK MEDICAL |
|---|---|
| Registered facility | COOK MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices may contain elevated levels of bacterial endotoxin. |
| Product | EchoTip® Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 |
| Quantity | 1 Unit OUS |
| Distribution | International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom. |
| Initiated | 2024-04-01 |
| Classified | 2024-05-16 |
| Recall number | Z-1832-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Medical Incorporated (Z-1832-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94395/
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