Z-3209-2024Class II

Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean...

Name: Z-3209-2024 Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean...
Creator: Microcare Medical
Published: 2024-08-29
License: https://open.fda.gov/license/

MicroCare Medical / initiated 2024-08-29 / Open, Classified / root cause: manufacturing process

FDA source

Microcare Medical began a recall of Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1... on 2024-08-29. FDA classified it as Class II and gives the reason as "Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3209-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-29
Posted: 2024-09-23
Recalling firm: MicroCare Medical
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
Product code: JCB Detergent
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 8/29/24, recall notices were mailed to customers who were asked to do the following: 1) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. This recall should be carried out to the user level. 2) If your company repacked these medical devices into convenience kits or into other packaging, please contact your local FDA recall coordinator to evaluate the need for a new recall (https://www.fda.gov/safety/industry-guidance-recalls/ora-recallcoordinators). 3) Return partially-used or unused product to the recalling firm. 4) Complete and return the response form via email to [email protected] If you have any questions, contact the firm at 303-529-5937 or the email above.
Quantity in commerce: 1649
Distribution: Worldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO, NY, MD, CA, MI, NE, UT, OK, WI, NJ, IL, ME, CT, KS, TX, NC, TN, SC, MO and the countries of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3209-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3209-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-23

Product code JCB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)