Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0029-2022 — Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

U.S. FDA — Device Enforcement · United States · 2021-08-23 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0029-2022
Date of alert
2021-08-23
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Aesthetics Systems Usa Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.