Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ultra/Phonic Focus BP Conforming Gel Pads Recalled by Pharmaceutical Innovations, Inc. Due to The firm registered the product as a Class...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pharmaceutical Innovations, Inc. directly.
Affected Products
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
Quantity: tbd
Why Was This Recalled?
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pharmaceutical Innovations, Inc.
Pharmaceutical Innovations, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report