Recall archive / FDA device enforcement
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 — FDA record Z-1833-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
- Reason
- Devices may contain elevated levels of bacterial endotoxin.
- Classification
- Class II
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 8 units OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1833-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 22, 2024
- Recall initiation date
- Apr 1, 2024
- Center classification date
- May 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.