CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Sterile Aquasonic 100 Ultrasound Transmission Gel recalled
Parker Laboratories is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel, distributed in 8 states. The recall was initiated on 13 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1777-2018
- FDA event ID
- 79910
- Recalling firm
- Parker Laboratories, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2017
- FDA classified
- 9 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 13 Apr 2017 | Recall initiated by company | |
| 9 May 2018 | Classified by FDA | +391 days |
| 16 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for the gel packets to have leaks in the packet seal.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Where it was distributed
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.
Questions about this recall
Why was it recalled?
There is a potential for the gel packets to have leaks in the packet seal.
Which lots are affected?
Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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