UnratedMedical device recall · FDA · Published August 13, 2020
Pharmaceutical Innovations recalls BP gel pads for ultrasound use
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. Read more at govinfonow.com/recall/64489-pharmaceutical-innovations-recalls-bp-gel-pads-for-ultrasound-use.
“Pharmaceutical Innovations recalls BP gel pads for ultrasound use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64489-pharmaceutical-innovations-recalls-bp-gel-pads-for-ultrasound-use. Based on FDA recall #Z-2830-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2830-2020%22&limit=1).
The FDA announced on Aug. 13, 2020, that Pharmaceutical Innovations, Inc. voluntarily recalled Ultra/Phonic Focus BP Conforming Gel Pads because the device requires a 510(k) submission but was registered as a Class I device.
How to tell if you have it
Brand: Pharmaceutical Innovations
Product: Ultra/Phonic Focus BP Conforming Gel Pads
According to the FDA, Pharmaceutical Innovations registered the Ultra/Phonic Focus BP Conforming Gel Pads as a Class I device but was informed that the device is not Class I and requires a 510(k) submission.
Context
GovInfoNow's records show Pharmaceutical Innovations, Inc. had one other recall on record since June 19, 2019: a June 19, 2019 recall of Alpha Conducting Solution due to failed antimicrobial testing. Other recent recalls of similar products include a Feb. 25, 2026 recall of Medline ENT Kits for rescinded 510(k) clearances and Feb. 27, 2026 recalls of Medline Convenience Kits involving unapproved syringes or design changes.
How to tell if you have this one
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.
Brand
Pharmaceutical Innovations
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Look for the specific lot numbers listed in the recall notice (021805-02 through 102119-02) on the gel pads.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the state of Nevada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2830-2020 (August 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2830-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.