Food, drugs, devices › Cook Medical Incorporated
Device recall: EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA enforcement event 94395 is a device recall by Cook Medical Incorporated of Bloomington, IN, initiated 1 Apr 2024 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cook Medical Incorporated has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Medical Incorporated, Bloomington, IN.
Reason for recall
"Devices may contain elevated levels of bacterial endotoxin."
Distribution
"International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1832-2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | 1 Unit OUS | Class II | Ongoing | 22 May 2024 |
| Z-1833-2024 | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 | 8 units OUS | Class II | Ongoing | 22 May 2024 |
Context
Other enforcement events for Cook Medical Incorporated
All 8 events for Cook Medical Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Devices may contain elevated levels of bacterial endotoxin."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.