FDA Medical Device Recalls (openFDA)
Pharmaceutical Innovations, Inc.: 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.
- Recall number
- Z-2830-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-08-13
- Posted
- not on file
- Terminated
- 2021-09-16
- Reason
- 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.
- 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
- tbd
- Distribution
- US Nationwide distribution including in the state of Nevada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUI
- Firm FEI
- 2241583
- Firm city
- Newark
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28