# FDA recall Z-2830-2020

> **Pharmaceutical Innovations, Inc.** · Class II · device recall initiated 2020-08-13.

## Product

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.

## Reason for recall

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.

## Distribution

US Nationwide distribution including in the state of Nevada.

## Key facts

- **Recall number:** Z-2830-2020
- **Recalling firm:** Pharmaceutical Innovations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-13
- **Report date:** 2020-08-26
- **Termination date:** 2021-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2830-2020

## Citation

> AI Analytics. FDA recall Z-2830-2020. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2830-2020. Source: US FDA. Licensed CC0.

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