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Lower risk Medical device recall · FDA · Published August 12, 2021

AMTEC EcoGel Ultrasound Gels Recalled Due to Bacterial Contamination Risk

AMTEC recalls EcoGel 100, EcoGel 200 (Blue/Clear) and Ecolotion due to potential bacterial contamination in ultrasound coupling gels.

🇺🇸 FDA recall #Z-2480-2021Medical deviceAMTEC SALES ›
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Recalling firmAMTEC SALES Inc1594 Nw 159th St · Miami, FL 33169-5635
✎ GovInfoNow plain-language explainer

What happened, in plain English

AMTEC is recalling several ultrasound gel and lotion products because they may contain bacteria. Using these products could lead to infections if they are contaminated. Read more at govinfonow.com/recall/61953-amtec-ecogel-ultrasound-gels-recalled-due-to-bacterial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61953-amtec-ecogel-ultrasound-gels-recalled-due-to-bacterial-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2480-2021

Cite this page

“AMTEC EcoGel Ultrasound Gels Recalled Due to Bacterial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61953-amtec-ecogel-ultrasound-gels-recalled-due-to-bacterial-contamination-risk. Based on FDA recall #Z-2480-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2480-2021%22&limit=1).

Why it’s dangerous

The ultrasound gels and lotions may have bacterial contamination, which could cause infections if introduced into the body during medical procedures. These products are used to create a smooth surface between ultrasound transducers and skin for imaging.

Who’s affected

Medical professionals and ultrasound technicians who use these products for imaging procedures are most at risk. Patients using the gels during medical procedures could also be affected.

How to tell if you have this one

Check for EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue or Clear), or Ecolotion Transmission Lotion. Look for specific product codes like 3541420, 3113545, or 6115004 on packaging.

  • Brand
    AMTEC SALES
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Labels

    Look for product names and specific item numbers on the packaging to confirm if your item is recalled.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution to US (nationwide) states of - FL, TX, OH, MD, PA, WA, CO, PR, VA, KY, OK, and CA; and OUS (international) to countries of - Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Kentucky, Maryland, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Aug 12, 202112. FDA classified it Class I: Sep 22, 202123. Published in FDA’s Enforcement Report: Sep 29, 202132021
  1. Firm started the recall
  2. FDA classified it Class I
  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-2480-2021 (August 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2480-2021 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