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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- North Coast Medical Inc
- 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.
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