FDA recall, , Moderate risk
Sporetraq Mail-In Spore Testing Service
Due to incorrect incubation process being performed on product.
Summary by Recall Canary from the FDA notice
What happened
HF Acquisition Co LLC, of Mukilteo, Washington, began a recall of its Sporetraq Mail-in Spore Testing Service on April 13, 2026, because an incorrect incubation process was performed on the product. The service includes bacterial spore strips intended for use in testing the efficacy of steri. The recall was added to the FDA's Enforcement Report on June 5, 2026, and covers nationwide distribution across the United States.
What to do
We don't have product-specific 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 yours affected?
2 products
Match the UDI-DI, model/catalog number and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
SporeTraq Mail-In Spore Testing Service, 52 Tests
- UDI-DI
- 00850065007496
- Model/Catalog number
- 1023780
- Affected units
- 1023780, 1023770, DSS-122, DSS-125, DSS-128, DSS-131, DSS-134
SporeTraq Mail-In Spore Testing Service, 12 Tests
- Model/Catalog number
- 1023770
- Lot code
- 1023780
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution including in the states of Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin.
- Company
- HF Acquisition Co LLCMukilteo, Washington
- Hazard
- Processing 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
- Event ID
- 98695
- Recall numbers
- Z-2331-2026 to Z-2332-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
