CLASS I ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

EcoLotion Transmission Lotion, used in ultrasound procedures recalled

North Coast Medical is recalling EcoLotion Transmission Lotion, used in ultrasound procedures, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots within the expiration date.

Quantity recalled53

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2583-2021
FDA event ID: 88613
Recalling firm: North Coast Medical, Morgan Hill, CA
Classification: Class I
Status: Ongoing
Recall initiated: 27 Aug 2021
FDA classified: 29 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

27 Aug 2021	Recall initiated by company
29 Sep 2021	Classified by FDA	+33 days
6 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

Product as listed by the FDA

EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

Where it was distributed

Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots within the expiration date.

Where was it sold?

Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88613

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS I	Norco Ultrasound Gel recalled by North Coast Medical	North Coast Medical	Other	Nationwide

More recalls from North Coast Medical

All 3

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25 Oct 2023Device	CLASS II	Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 recalled	North Coast Medical	Labeling Errors	CA, NC, WI
6 Oct 2021Device	CLASS I	Norco Ultrasound Gel recalled by North Coast Medical	North Coast Medical	Other	Nationwide

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