SPORETRAQ Mail-In Spore Testing Service Recall
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HF Acquisition Co LLC recalls SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS (model 1023770) due to incorrect incubation process.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
HF Acquisition Co LLC is conducting a voluntary Class II recall of the SPORETRAQ MAIL-IN SPORE TESTING SERVICE because an incorrect incubation process was performed on the product.
Which Products Are Affected
The recall affects the SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS (Model/Catalog Number: 1023770). The recall scope is being expanded to include the SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS (model 1023780) and other products serviced by Mesa Labs. Affected lot codes are those not incubated per the required times: 24 hours for steam sterilizers, 72 hours for chemiclave sterilizers, and 7 days for dry heat or ethylene oxide sterilizers. Distribution was nationwide across the United States, including AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI.
What You Should Do
Consumers in possession of the affected products should refer to notifications from the recalling firm regarding the expanded scope.
Why This Matters
The recall addresses a manufacturing process deviation affecting spore testing used to verify sterilizer efficacy in healthcare facilities.
Source
FDA recall number Z-2332-2026; HF Acquisition Co LLC, Mukilteo, WA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,312 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.