CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle recalled

Cook Medical is recalling EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, Echo-hd-19-A, G52012. The recall was initiated on 1 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

Quantity recalled1 Unit OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1832-2024
FDA event ID: 94395
Recalling firm: Cook Medical, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 1 Apr 2024
FDA classified: 16 May 2024
Reported: 22 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

1 Apr 2024	Recall initiated by company
16 May 2024	Classified by FDA	+45 days
22 May 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices may contain elevated levels of bacterial endotoxin.

Product as listed by the FDA

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

Where it was distributed

International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

Questions about this recall

Why was it recalled?

Devices may contain elevated levels of bacterial endotoxin.

Which lots are affected?

Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

Where was it sold?

International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 94395

Reported	Class	Recall	Company	Reason	Where
22 May 2024	CLASS II	EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, Echo-19, G31520 recalled	Cook Medical	Other	IN

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