Ultra/Phonic Focus BP Conforming Gel Pads — Class II medical device recall Z-2830-2020
Terminated recall by Pharmaceutical Innovations, Inc., reported 2020-08-26, distributed nationwide. The firm registered the product as a Class I device, but has since been informed by FDA that the device is not
| Recall number | Z-2830-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmaceutical Innovations, Inc., Newark, NJ, United States |
| Recall initiated | 2020-08-13 |
| Classified | 2020-08-20 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2021-09-16 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00300361301021, 10300361301028 |
| Lot numbers | 010416-02, 011013-02, 011312-02, 011313-02, 011316-02, 011414-02, 020115-02, 020216-02, 020517-02, 020619-02, 020919-02, 021016-02, 021018-02, 021314-02, 021411-02, 021413-02, 021617-02, 021805-02, 021911-02, 022112-02, 022614-02, 030115-02, 030211-02, 030313-02, 030412-02, 030516-02, 030614-02, 030711-02, 030805-02, 030812-02, 030817-02, 031318-02, 031517-02, 032417-02, 040418-02, 040717-02, 040718-02, 041017-02, 041118-02, 041318-02 and 67 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2830-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.