EchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving elevated levels of bacterial endotoxin in a medical device designed for tissue access. No illnesses, injuries, or hospitalizations have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Cook Medical Incorporated has recalled the EchoTip Ultra HD Endoscopic Ultrasound Access Needle (Model ECHO-HD-19-A, GPN G52012) because the devices may contain elevated levels of bacterial endotoxin. The affected lot numbers are C2145003 and C2144407.
The recalled devices were distributed internationally to healthcare facilities in Germany, Netherlands, Switzerland, and the United Kingdom. Healthcare providers in these countries should check whether they have products from the affected lots.
Facilities with devices from the recalled lots should contact Cook Medical for guidance on appropriate next steps.
The recalled product
- Product
- EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Manufacturer
- Cook Medical Incorporated
- Hazard
- bacterial-endotoxin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalogue Number: ECHO-HD-19-A
- GPN: G52012
- UDI/DI: 00827002520127
- Lot Numbers: C2145003 and C2144407.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27