Burkholderia infections have been traced before to contaminated nonsterile ultrasound gel used during percutaneous procedures — ones that pierce the skin. In 2024, a related and unusual bacterium set off an international investigation.
An unexpected bacterium
In August 2024, the Minnesota Department of Health Public Health Laboratory (MDH-PHL) noticed more blood-culture isolates identified as Paraburkholderia fungorum (or Paraburkholderia species). P. fungorum is an environmental organism, not an established human pathogen, and the lab hadn't seen it in any clinical specimen in the previous decade.
- Seven isolates, sent in to rule out the bioterrorism agents Burkholderia mallei and B. pseudomallei, proved closely related by whole genome sequencing (WGS).
- One lab found eight more patients back to September 2023.
- Each patient had only one positive bottle among their blood cultures — suggesting contamination rather than true infection.
- On October 1, 2024, MDH-PHL alerted labs statewide, turning up 30 more positive cultures from Minnesota, North Dakota and 11 other states.
At first, suspicion fell on the blood culture bottles, since all U.S. cases involved one manufacturer.
Three countries, one clone
Labs in North Carolina, Canada and Israel — the latter two after finding Minnesota's public alert online — joined in late 2024 and early 2025. In all, 43 isolates from 42 patients were sequenced: 12 from Minnesota, 15 from North Carolina, 1 from North Dakota, 4 from Canada and 10 from Israel. All came from blood, except three from Israel from abdominal (ascitic) fluid.
Israel's cases broke the case open. They used a different blood culture system, which made contaminated bottles unlikely — and patients whose fluid was drawn by paracentesis had been scanned with nonsterile ultrasound gel at the bedside.
| Evidence | |
|---|---|
| Gel cultures | P. fungorum grew from six lots of nonsterile gel of two brands, ClearImage and MediChoice, both made by NEXT Medical Products Company — in Israel, the U.S. and Canada |
| Genomes | all clinical and gel isolates differed by only 0–10 single-nucleotide changes — a single clone — and were far from a 2011 isolate and from public genomes |
Patients by date of first specimen, in Minnesota, North Carolina, North Dakota, Canada and Israel. Image from CDC's report
Image from CDC's report
The patients
- 39 had positive blood cultures; 3 positive ascitic fluid.
- One had a confirmed invasive infection — a central-line–associated bloodstream infection, with three positive cultures over several days. In the three ascitic fluid cases, peritonitis was ruled out.
- Of 37 with clinical details, 28 had antibiotics started, changed or extended because of the result; clinicians ultimately judged 25 to be contamination.
- 16 had a documented ultrasound-guided procedure before or during sampling — most often IV placement and blood draws in the emergency department — and gel use was confirmed for 15.
The response
Facilities reviewed how they used gel, removed the implicated products and received guidance; CDC, the Food and Drug Administration, health authorities in Canada and Israel, and the manufacturer were informed. On May 13, 2025, CDC alerted clinicians.
Use only sterile, single-use ultrasound gel before, during or after any procedure that breaks the skin at the ultrasound site — nonsterile gel is not recommended for percutaneous procedures. Sharing genome data across borders made this investigation possible.
Sources
Based on Sarah Lim, Paula Snippes Vagnone, Natalie C. Marshall and others, "Detection of Paraburkholderia in Clinical Specimens Associated with Use of Nonsterile Ultrasound Gel for Percutaneous Procedures — United States, Canada, and Israel, May 2023–April 2025," MMWR, volume 74, Centers for Disease Control and Prevention; a work of the United States government in the public domain.
Licence: CC0 1.0 (public domain) · Adapted from www.cdc.gov
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