PlainRecalls
FDA Devices Moderate Class II Ongoing

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Reported: May 22, 2024 Initiated: April 1, 2024 #Z-1832-2024

Product Description

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Reason for Recall

Devices may contain elevated levels of bacterial endotoxin.

Details

Recalling Firm
Cook Medical Incorporated
Units Affected
1 Unit OUS
Distribution
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012. Recalled by Cook Medical Incorporated. Units affected: 1 Unit OUS.
Why was this product recalled?
Devices may contain elevated levels of bacterial endotoxin.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1832-2024.