Reported Jun 17, 2026 · Ongoing

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52…

HF Acquisition Co. LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: HF Acquisition Co LLC · 11629 49th Pl W · Mukilteo, WA · 98275-4255

Is this the product you have?

  • Brand NameSPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52
  • TESTS Product NameSPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52
  • TESTS Model/Catalog Number1023780
  • Software VersionN/A
  • Product DescriptionThe SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access
  • ComponentN/A
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
Spore strips used in steam sterilizers are incubated for 24 hours
Spore strips used in chemiclave sterilizers are incubated for 72 hours
102378000850065007496Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs. Product/ UDI-DI code: 00850065007496 Lot Numbers: DSS-122 DSS-125 DSS-128 DSS-131 DSS-134
Amount recalled
2210

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Due to incorrect incubation process being performed on product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.