The Recall Desk
HighFDA (Devices)·Z-3209-2024·Announced 2024-10-02

Ultrasonic Cleaner Solution Recalled for Bacterial Contamination and Infection Risk

Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with contamination by pathogenic bacteria (Klebsiella oxytoca, Enterobacter species) capable of causing serious infections. No illnesses or injuries currently reported, making this a high-risk theoretical hazard.

Plain-English summary

Microcare Medical is recalling Good Vibrations, JorVet J0382G, and SpecClean Ultrasonic Cleaner Solutions. Approximately 1,649 units were distributed across multiple U.S. states and Canada.

The solutions are contaminated with pathogenic and opportunistic bacteria including Klebsiella oxytoca, Enterobacter asburiae, and Enterobacter bugandensis, originating from contaminated equipment and packaging during manufacturing. The contamination causes product bloating and leaking.

If used during medical or dental procedures, the contaminated solutions could cause urinary tract infections, respiratory infections, or bloodstream infections in patients. Healthcare workers handling contaminated product and instruments are at risk of similar infections.

The recall identifies specific lot and model numbers to distinguish affected products.

The recalled product

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
Manufacturer
Microcare Medical
Hazard
  • bacterial-contamination
  • klebsiella
  • enterobacter
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Lot/Model: 2331982/GVUS128-1EA
  • GVUS128-1
  • GVUS550-1
  • 2332204/GVUS128-1EA
  • JGVUS128-1
  • VGVUSNP128-1EA
  • VGVUSNP128-1
  • 2332393/GVUS128-1EA
  • GVUS24-1EA
  • GVUS24-1
  • GVUS128-1 2432755/JGVUS128-1 2432989/GVUS24-1EA
  • JGVUS128-1 Model/UDI-DI: GVUS128-1/+H816GVUS128H
  • GVUS24-1/+H816GVUSU24%
  • GVUS550-1/+H816GVUS550G
  • VGVUS128-1/+H816VGVUSNP128A
  • JGVUS128-1/723754044532

Distribution

Distributed nationwide across the United States.