FDA Device recall Z-3209-2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution,…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution,… by Microcare Medical, citing contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic dete….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3209-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-29 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microcare Medical |
| Distribution | US |
Product
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
Reason
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Identifiers
| code_info | Lot/Model: 2331982/GVUS128-1EA, GVUS128-1, GVUS550-1; 2332204/GVUS128-1EA, JGVUS128-1, GVUS128-1, VGVUSNP128-1EA, VGVUS…Lot/Model: 2331982/GVUS128-1EA, GVUS128-1, GVUS550-1; 2332204/GVUS128-1EA, JGVUS128-1, GVUS128-1, VGVUSNP128-1EA, VGVUSNP128-1; 2332393/GVUS128-1EA, VGVUSNP128-1, GVUS24-1EA, GVUS24-1, GVUS128-1 2432755/JGVUS128-1 2432989/GVUS24-1EA, VGVUSNP128-1EA, GVUS24-1, VGVUSNP128-1, JGVUS128-1 Model/UDI-DI: GVUS128-1/+H816GVUS128H, GVUS24-1/+H816GVUSU24%, GVUS550-1/+H816GVUS550G, VGVUS128-1/+H816VGVUSNP128A, JGVUS128-1/723754044532 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3209-2024%22
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