The Recall Desk
CriticalFDA (Devices)·Z-2582-2021·Announced 2021-10-06

Ultrasound Gel Products Recalled for Possible Bacterial Contamination

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I recall: the agency applies this classification when serious adverse health consequences are expected from the hazard of bacterial contamination in medical products used during medical procedures.

Plain-English summary

The FDA issued a recommendation on August 18, 2021, instructing healthcare providers to stop using ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. due to the risk of bacterial contamination. All product lots within the manufacturer's established expiration date are included in this recall.

Affected products have been distributed worldwide, including throughout the United States, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, the Cayman Islands, and Switzerland. Products are supplied in multiple sizes and container formats.

Healthcare facilities should immediately discontinue use of recalled Eco-Med ultrasound gel and lotion products and replace them with alternatives from other manufacturers. For specific product codes and additional guidance, healthcare providers should consult the FDA's Letter to Health Care Providers issued on August 18, 2021.

The recalled product

Product
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coas
Manufacturer
North Coast Medical Inc
Category
Medical Device — Diagnostic / Ultrasound
Hazard
Affected units
576

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 (1)

  • All lots within the expiration date.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by North Coast Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · North Coast Medical Inc

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Same hazard · bacterial contamination

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