Cook Medical Incorporated EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Brand
Cook Medical Incorporated
Lot Codes / Batch Numbers
Catalogue Number: ECHO-19, GPN: G31520, UDI/DI: 00827002315204, Lot Numbers: C2145003 and C2144407.
Products Sold
Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Cook Medical Incorporated is recalling EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 due to Devices may contain elevated levels of bacterial endotoxin.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices may contain elevated levels of bacterial endotoxin.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026