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

Omnisound Gel bottle and container recalled by Accelerated Care Plus

Accelerated Care Plus is recalling Omnisound Gel bottle and container, distributed nationwide in the US. The recall was initiated on 25 Aug 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesDistributed from January 1, 2018 thru August 4, 2021

Quantity recalled9436

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-2518-2021
FDA event ID: 88602
Recalling firm: Accelerated Care Plus, Reno, NV
Classification: Class I
Status: Ongoing
Recall initiated: 25 Aug 2021
FDA classified: 24 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

25 Aug 2021	Recall initiated by company
24 Sep 2021	Classified by FDA	+30 days
6 Oct 2021	Published in enforcement report	+12 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

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Is Omnisound Gel bottle and container recalled?

Yes. Accelerated Care Plus recalled Omnisound Gel bottle and container on 25 Aug 2021. The recall is Class I and its status is Ongoing. Recall number Z-2518-2021.

Why was it recalled?

Which lots are affected?

Distributed from January 1, 2018 thru August 4, 2021

Where was it sold?

US nationwide distribution.

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

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