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Open, Classified

50-GEL20; Ultrasound gel

FDA Recall Z-2533-2023 · Posted 2023-09-09

Recalling FirmAdvance Medical Designs, Inc.
Recall StatusOpen, Classified
Product CodeMUI
Date Initiated2023-07-07
Product Quantity13750 units

Reason for Recall

Ultrasound gel mislabeled with inappropriate use.

Firm Action

Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.

Root Cause

Other

Distribution Pattern

US, Canada, UK, Panama, Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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