Z-2830-2020Class II

Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) -

Name: Z-2830-2020 Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) -
Creator: Pharmaceutical Innovations, Inc.
Published: 2020-08-13
License: https://open.fda.gov/license/

Pharmaceutical Innovations, Inc. / initiated 2020-08-13 / Terminated

FDA source

Pharmaceutical Innovations, Inc. began a recall of Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during... on 2020-08-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2830-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-13
Posted: 2020-08-20
Terminated: 2021-09-16
Recalling firm: Pharmaceutical Innovations, Inc.
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.
Product code: MUI Media, Coupling, Ultrasound
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.
FDA root cause: No Marketing Application
Action: On 8/13/2020, the firm distributed Urgent Medical Device Recall letters to its distributor, with instructions to notify all affected customers who received the product. Customers were informed that the product had been misclassified by the firm and required a 510(k) submission to FDA. Customers were instructed to identify and quarantine the products, and to cease use and sales of the product. Customers are to complete the included response form and return it to the firm. The firm will issue a Return Material Authorization for the return of the product. No option will be given to destroy product in the field. Customers should notify all users within their facility as well as any downstream accounts if the product has been further distributed/ transferred.
Quantity in commerce: tbd
Distribution: US Nationwide distribution including in the state of Nevada.
Product codes and lots: Lots 021805-02 030805-02 050405-02 051106-02 052406-02 101006-02 101806-02 103406-02 052708-02 053308-02 060308-02 111208-02 111908-02 112108-02 050309-02 050809-02 101009-02 101309-02 061310-02 061710-02 061910-02 021411-02 021911-02 030211-02 030711-02 070711-02 113211-02 113311-02 011312-02 022112-02 030412-02 030812-02 061712-02 061912-02 070512-02 120612-02 011013-02 011313-02 021413-02 030313-02 051313-02 052713-02 060113-02 120613-02 011414-02 021314-02 022614-02 030614-02 060914-02 061314-02 062014-02 070714-02 100314-02 101614-02 110914-02 120314-02 020115-02 030115-02 060615-02 061315-02 070515-02 070815-02 100315-02 100615-02 110315-02 110715-02 120316-02 010416-02 011316-02 020216-02 021016-02 030516-02 052016-02 060316-02 091416-02 092316-02 100616-02 101516-02 102116-02 020517-02 021617-02 030817-02 031517-02 032417-02 040717-02 041017-02 050617-02 060317-02 071217-02 071917-02 080417-02 081717-02 091017-02 091617-02 092317-02 100517-02 021018-02 031318-02 040418-02 040718-02 041118-02 041318-02 041818-02 051218-02 060718-02 020619-02 020919-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2830-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2830-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-20

Product code MUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)