Z-1832-2024Class II

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

Name: Z-1832-2024 EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Creator: Cook Medical Incorporated
Published: 2024-04-01
License: https://open.fda.gov/license/

Cook Medical LLC / initiated 2024-04-01 / Open, Classified / root cause: manufacturing process

FDA source

Cook Medical Incorporated began a recall of EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 on 2024-04-01. FDA classified it as Class II and gives the reason as "Devices may contain elevated levels of bacterial endotoxin". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1832-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-01
Posted: 2024-05-16
Recalling firm: Cook Medical LLC
Product: EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Product code: FCG Biopsy Needle
Reason for recall: Devices may contain elevated levels of bacterial endotoxin.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1 Unit OUS
Distribution: International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Product codes and lots: Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-16
Z-1833-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-16

Product code FCG

K092359Class IIEcho Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-Hd-19ACook Ireland, Ltd. / cleared 2009-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)