EchoTip recallZ-1833-2024 · Cook Medical Incorporated · initiated Apr 1, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Medical Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices may contain elevated levels of bacterial endotoxin.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On April 01, 2024, Cook Ireland Ltd.(CIRL) initiated a field action for the EchoTip Ultra High Definition Ultrasound Access Needle (ECHO-HD-19-A) and EchoTip Ultra Endoscopic Ultrasound Needle (ECHO-19). Cook Ireland Ltd has identified 9 devices located outside of the United States (US) that are associated with the issue and has initiated a voluntary recall due to the potential of elevated levels of bacterial endotoxins on the devices. No US customers were impacted by this Field Safety Corrective Action (FSCA). No monitoring will be required as US consignees are not impacted by this recall. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.
Recall details
- Recall number
- Z-1833-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 1, 2024
- Posted by the FDA
- May 16, 2024
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 8 units OUS
- Product code
- FCG
- FDA submissions
- K210476
- Distribution
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Product description
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Code information (models, lots, serial numbers)
Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94395).
- Z-1832-2024 · Open, ClassifiedEchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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