RecallRadar

FDA Device recall Z-1832-2024

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

On 2024-05-22 the FDA classified a Class II recall of EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 by Cook Medical, citing devices may contain elevated levels of bacterial endotoxin.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1832-2024
ClassificationClass II
Statusongoing
Initiated2024-04-01
Published2024-05-22
Last updated2026-09-13 11:57 UTC
CompanyCook Medical
Distributionn/a

Product

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

Reason

Devices may contain elevated levels of bacterial endotoxin.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1832-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.