FDA recall, , Moderate risk
Remel Yeastone Broth
Yeastone Broth may report false susceptibility to antifungal agents.
Summary by Recall Canary from the FDA notice
What happened
Remel, Inc., of Lenexa, Kansas, voluntarily initiated a recall of Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens, because the affected lot did not meet specifications. The product may report false susceptibility to antifungal agents, specifically within the Azole family. The recall began October 19, 2026, and was added to the FDA's Enforcement Report on November 3, 2026.
The product was distributed worldwide, including US Nationwide distribution in the states of MA and CA, and the countries of India, Saudi Arabia, and the UK. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your box affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Yeastone Broth, 11ML, 10/Box, used in antibiotic susceptibility testing of mycological clinical specimens
- UDI-DI
- 848838018817
- Lot code
- 440400
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
Worldwide - US Nationwide distribution in the states of Massachusetts and California. The countries of India, Saudi Arabia, UK.
- Recalled by
- Remel, IncLenexa, Kansas
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100139
- Recall number
- Z-0355-2027
- Quantity recalled
- 33 US, 54 OUS
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Remel began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
