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Lower risk Medical device recall · FDA · Published April 1, 2024

Cook Medical EchoTip Ultra HD Needle Recall: Bacterial Endotoxin Risk

Cook Medical recalls EchoTip Ultra HD Endoscopic Ultrasound Access Needles (ECHO-HD-19-A, G52012) due to potential bacterial endotoxin contamination. Affected units may pose health risks during medical procedures.

🇺🇸 FDA recall #Z-1832-2024Medical deviceCook Medical ›
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Recalling firmCook Medical Incorporated400 N Daniels Way · Bloomington, IN 47404-9155
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cook Medical is recalling specific EchoTip Ultra HD Endoscopic Ultrasound Access Needles because they may contain elevated levels of bacterial endotoxin. This could pose health risks during medical procedures if the needles are used without proper sterilization. Read more at govinfonow.com/recall/55674-cook-medical-echotip-ultra-hd-needle-recall-bacterial-endotoxin-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/55674-cook-medical-echotip-ultra-hd-needle-recall-bacterial-endotoxin-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1832-2024

Cite this page

“Cook Medical EchoTip Ultra HD Needle Recall: Bacterial Endotoxin Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55674-cook-medical-echotip-ultra-hd-needle-recall-bacterial-endotoxin-risk. Based on FDA recall #Z-1832-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1832-2024%22&limit=1).

Why it’s dangerous

The needles may contain elevated levels of bacterial endotoxin, which can cause infections or adverse reactions if introduced into the body during medical procedures. This risk is particularly concerning in sterile environments where strict infection control is required.

Who’s affected

Medical professionals who use the recalled EchoTip Ultra HD needles for endoscopic ultrasound procedures are most at risk. Patients receiving these procedures with the recalled needles could also be affected.

How to tell if you have this one

Check for the model ECHO-HD-19-A and lot numbers C2145003 or C2144407 on the needle packaging or label. The product was sold under the catalog number ECHO-HD-19-A and global product number G52012.

  • Brand
    Cook Medical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-1832-2024EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012; Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.1 Unit OUS
Z-1833-2024EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520; Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.8 units OUS
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model ECHO-HD-19-A and lot numbers C2145003 or C2144407 on the needle packaging or label.

How this recall unfolded

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Apr 1, 202412. FDA classified it Class II: May 16, 202423. Published in FDA’s Enforcement Report: May 22, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1832-2024 (April 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1832-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA