Sterile Aquasonic 100 Ultrasound Transmission Gel — Class II medical device recall Z-1777-2018
Terminated recall by Parker Laboratories, Inc., reported 2018-05-16, distributed in CA, FL, GA, IA, IL, OH, TN, VA. There is a potential for the gel packets to have leaks in the packet seal.
| Recall number | Z-1777-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Parker Laboratories, Inc., Fairfield, NJ, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-10-26 |
| Distributed | CA, FL, GA, IA, IL, OH, TN, VA |
| Countries outside the US | CA, GB, MT |
| Reason classes | packaging |
| Lot numbers | L0117006, L0117007, L0217001, L0217002, L0217004, L0217006 |
| Model numbers | 01-01-4, 400 |
Product
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Reason for recall
There is a potential for the gel packets to have leaks in the packet seal.
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-1777-2018. 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.