{"url_path":"/fda/device/recalls/Z-2331-2026","section_key":"summary","section_title":"DEVICE Recall: HF Acquisition Co LLC — Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS  Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS  Model/Catalog Number: 1023780  Software Version: N/A  Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus A…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"HF Acquisition Co LLC"},"word_count":373,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2331-2026\n\n**Recalling firm:** HF Acquisition Co LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-13\n**Report date:** 2026-06-17\n\n## Product\nBrand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS  Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS  Model/Catalog Number: 1023780  Software Version: N/A  Product Description: The 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.  Component: N/A\n\n## Reason\nDue to incorrect incubation process being performed on product.\n\n## Affected lots\nLot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore 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/Item Number: 1023780 UDI-DI code: 00850065007496 Lot Numbers: DSS-122 DSS-125 DSS-128 DSS-131 DSS-134\n\n## Distribution\nU.S. Nationwide distribution including in the states of 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."}