Pharmaceutical Innovations recalls Ultra/Phonic Focus BP Conforming Gel Pads due to FDA classification error; these pads are used during ultrasound exams for patient comfort and nipple location.
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.
Pharmaceutical Innovations is recalling Ultra/Phonic Focus BP Conforming Gel Pads used during ultrasound exams. The recall is because the company previously registered the product as a Class I medical device but the FDA later determined it requires a 510(k) submission instead.
The product was initially registered as a Class I medical device by the manufacturer, but the FDA later determined it does not meet Class I standards and requires a full 510(k) submission process. This classification error means the device may not be safe or effective for its intended use.
Women who use ultrasound exams for medical purposes may own these gel pads. Those with the specific lot numbers listed in the recall notice are most at risk.
Check for the lot numbers listed in the recall notice: 021805-02 through 102119-02. These gel pads are used during ultrasound exams for patient comfort and nipple location identification.
Look for the specific lot numbers listed in the recall notice (021805-02 through 102119-02) on the gel pads.
The manufacturer initially registered the product as a Class I medical device, but the FDA later determined it requires a 510(k) submission instead.
Check the lot numbers on the gel pads to see if they are in the recalled list. If they are, contact the manufacturer for further instructions.
The recall is due to a classification error, not a safety hazard. The product is intended for use during ultrasound exams for patient comfort and nipple location identification.
We’ve drafted a message you can send Pharmaceutical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-2830-2020 — Pharmaceutical Innovations Pharmaceutical Innovations Hello, I own a Pharmaceutical Innovations that is covered by recall Z-2830-2020 from Pharmaceutical Innovations. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
