Fresh Recalls

FDAClass II · Medical device · Recall Z-2331-2026 · Recalled June 17, 2026

Brand Name recall — HF Acquisition Co LLC

Agency report date: June 17, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Brand Name
Company / brand
HF Acquisition Co
Lot / serial / date codes
Lot 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
Distribution
U.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.
Agency product description and boundaries

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 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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Due to incorrect incubation process being performed on product.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brand Name recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2331-2026
Brand
All HF Acquisition Co recalls
Classification
Class II
Units affected
2,210
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Mukilteo, WA, United States
Firm address
11629 49th Pl W, N/A, 98275-4255

Identifying details (verbatim from the notice)

Product codes / lots
Lot 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
Distribution
U.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.
Firm notified the public via
Letter
FDA event ID
98695
Recall initiated
April 13, 2026
FDA classified
June 5, 2026
FDA report date
June 17, 2026

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 15, 2026 at 6:00 PM UTC.

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