FDA Medical Device Recalls (openFDA)
Pharmaceutical Innovations, Inc.: Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
- Recall number
- Z-1653-2012
- Recalling firm
- Pharmaceutical Innovations, Inc.
- Product
- Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
- Status
- Terminated
- Initiated
- 2012-03-02
- Posted
- 2012-05-24
- Terminated
- 2021-07-19
- Reason
- Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.
- Root cause
- Employee error
- Action
- Phamaceutical Innovations Inc. sent an Urgent Message Notice letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax to all affected customers. Customers were instructed to examinne inventory, refrain from distribution and return remaining inventory for a replacement. For questions call 973-242-2900.
- Quantity
- 40,164 units in distribution worldwide - unable to obtain units in distribution Nationwide
- Distribution
- Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.
- Lot, serial or model codes
- 060111 080111 090111 100811
- 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