FDA Medical devices recall ·
SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ… recall
- Recall number
- Z-2331-2026
- Date
- (initiated April 13, 2026)
- Company / brand
- HF Acquisition Co LLC
11629 49th Pl W, Mukilteo, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2210
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to incorrect incubation process being performed on product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: 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 Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2331-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.