Class II — Parker Laboratories, Inc.
| Recalling firm | PARKER LABORATORIES, INC. |
|---|---|
| Registered facility | PARKER LABORATORIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the gel packets to have leaks in the packet seal. |
| Product | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case |
| Quantity | 3275 cases/1310000 packets |
| Distribution | The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta. |
| Initiated | 2017-04-13 |
| Classified | 2018-05-09 |
| Terminated | 2020-10-26 |
| Recall number | Z-1777-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Parker Laboratories, Inc. (Z-1777-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79910/
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