Drug recall
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA recall event 94395 · Class II · Cook Medical Incorporated
Key facts
| Event ID | 94395 |
|---|---|
| Recall numbers | Z-1832-2024, Z-1833-2024 |
| Recalling firm | Cook Medical Incorporated |
| Product type | Devices |
| Products | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520, EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Devices may contain elevated levels of bacterial endotoxin. |
| Initiation date | Apr 1, 2024 |
| Report date | May 22, 2024 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 3005580113 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: