The Recall Desk
SevereFDA (Devices)·Z-2480-2021·Announced 2021-09-29

Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination

Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions that may contain bacterial contamination. Products were distributed nationally and internationally.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which per FDA classification indicates a serious health hazard. Although no illnesses or injuries have been reported, the regulatory classification itself indicates bacterial contamination poses a significant risk.

Plain-English summary

Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions including EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue and Clear variants), and EcoLotion Transmission Lotion. These medical devices are intended for use as acoustic coupling media in ultrasound procedures.

The products may contain bacterial contamination. No illnesses or injuries have been reported to date.

Approximately 34,586 units were distributed. In the United States, the products reached Florida, Texas, Ohio, Maryland, Pennsylvania, Washington, Colorado, Puerto Rico, Virginia, Kentucky, Oklahoma, and California. International distribution included Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica.

Consumers who have these products should discontinue use and contact the manufacturer for further instructions. Healthcare facilities should review their inventory and follow appropriate procedures for managing the recalled products.

The recalled product

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 in
Manufacturer
AMTEC SALES Inc
Category
Medical Device — Ultrasound Coupling Media
Hazard
  • bacterial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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
  • Print Media Item Number 3158655 (12 each/pack
  • 72 each/case) 6) Ecogel 200 Multipurpose Gel CLEAR
  • Print Media Item Number 7565432 (1 each/pack
  • 4 each/case) 7) Ecolotion Transmission Lotion
  • Print Media Item Number 6115004 (1 each/pack
  • 4 each/case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category