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U.S. Department of Health and Human Services

Class 1 Device Recall Omnisound gel and EcoGel

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  Class 1 Device Recall Omnisound gel and EcoGel see related information
Date Initiated by Firm August 25, 2021
Create Date September 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-2518-2021
Recall Event ID 88602
510(K)Number K955246  
Product Classification Transducer gel, ultrasonic, diagnostic - Product Code ITX
Product Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Code Information Distributed from January 1, 2018 thru August 4, 2021
Recalling Firm/
Accelerated Care Plus Corporation
4999 Aircenter Cir Ste 103
Reno NV 89502-7923
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Process control
Action On 08/25/2021, Medical Device Recall notices were mailed and emailed to customers who were asked to take the following actions: Immediately stop use of all Eco-Med products. - Destroy and render unusable all affected products that you received from ACPL, by disposing the gel along with your general medical waste. - Carefully read the Recall Notice and follow the instructions, including completing the Eco-Med Product Recall Response Form indicating that you have read the recall notice and will take appropriate action including documenting the quantity of product in inventory and the quantity destroyed. - If you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Customers with additional questions or concerns can call Customer Support at 800.350.1100.
Quantity in Commerce 9436
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.