Z-2480-2021Class I

EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and...

Name: Z-2480-2021 EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and...
Creator: AMTEC SALES Inc
Published: 2021-08-12
License: https://open.fda.gov/license/

AMTEC SALES Inc / initiated 2021-08-12 / Open, Classified / root cause: manufacturing process

FDA source

AMTEC SALES Inc began a recall of EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for... on 2021-08-12. FDA classified it as Class I and gives the reason as "Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2480-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-12
Posted: 2021-09-22
Recalling firm: AMTEC SALES Inc
Product: EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Amtec/Print Media, issued a "URGENT: MEDICAL DEVICE RECALL - EXPANSION" notification letter to all impacted customers. This letter will be sent via email and includes a form that each customer is required to complete to indicate the recall information has been received and understood. The customers were also requested to do the following: 1. Please identify, quarantine, and destroy the product at your location; and provide a signed affidavit acknowledging its destruction. Please return this information via email to [email protected] or contact us for other return methods. 2. Forward this notice to any accounts to whom you have further distributed the product. 3. Please use the following link to verify your receipt and understanding of the attached MEDICAL DEVICE RECALL EXPANSION notice/instructions, and provide quantity of products on hand. Please respond even if you do not have any affected product on hand, since this is our only way of ensuring that all customers have been adequately notified. https://lp.constantcontactpages.com/sv/jjwlFMb/urgentrecallnotice Customers must contact Print Media to confirm receipt of this notice and that they are proceeding with the recall via email, [email protected], to contact Print Media directly with questions, call (800) 994-3318, or (305) 884-0700.
Quantity in commerce: 34,586 each
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.
Product codes and lots: 1) Ecogel 100 Imaging Gel, 250 mL bottle, Print Media Item Number 3541420 (12 each/pack; 72 each/case) 2) Ecogel 100 Imaging Gel, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 3874672 (1 each/pack; 4 each/case) 3) Ecogel 200 Multipurpose Gel BLUE, 250mL bottle, Print Media Item Number 3113545 (12 each/pack, 72 each/case) 4) Ecogel 200 Multipurpose Gel BLUE, Set: 5L jug with 250mL dispenser, Print Media Item Number 1000033 (1 each/pack, 4 each/case) 5) Ecogel 200 Multipurpose Gel CLEAR, 250mL bottle, Print Media Item Number 3158655 (12 each/pack, 72 each/case) 6) Ecogel 200 Multipurpose Gel CLEAR, Set: 5L jug with 250mL dispenser, Print Media Item Number 7565432 (1 each/pack, 4 each/case) 7) Ecolotion Transmission Lotion, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 6115004 (1 each/pack, 4 each/case)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2480-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2480-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-22

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)