Z-2518-2021 Class I Ongoing
FDA device recall Z-2518-2021 was initiated by Accelerated Care Plus Corporation on Aug 25, 2021 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 9436.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 6, 2021
- Initiation Date
- Aug 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9436
Product Description
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
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
Distribution Pattern
US nationwide distribution.
Code Information
Distributed from January 1, 2018 thru August 4, 2021
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2518-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026