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Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… recallZ-2331-2026 · HF Acquisition Co LLC · initiated Apr 13, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HF Acquisition Co LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to incorrect incubation process being performed on product.

FDA root cause category: Under Investigation by firm

What the company is doing

On 04/13/2026, the firm emailed an "URGENT: Medical Device Field Correction" Letter to customers informing them that the firm has identified a laboratory testing service error associated with 1023780 SporeTraq" Mail-In Spore Testing Service, 52 Tests affecting customers using Dry Heat, Chemiclave and Ethylene Oxide autoclave types. Specifically, the incubation criteria applied to the test samples may not have complied with the above requirement for the respective autoclave type. Failure to adhere to appropriate incubation criteria impacts the validity of sterilization process followed at customer locations. Customers are instructed to: 1. Log into your OnTraq" account at ontraq.healthfirst.com. 2. A banner will appear stating ACTION REQUIRED: Review to confirm or update your autoclave types. Go to the Confirmations Page. prompting you to verify the autoclave type. 3. Verify that the autoclave type is accurate by clicking the "Go to the Confirmations Page" hyperlink or navigating to "Confirm Autoclave Type" tab - If all information is accurate as it is, click on the CONFIRM button. - If not, edit by clicking the pencil icon next to the relevant data field, enter the updated information and click on the SAVE button. - If the autoclave is no longer in use, click the DEACTIVATE button and confirm the action in the pop-up window. 4. If the above actions were completed prior to receipt of this notification via email, mail or telephone, no further action is required. For questions - contact Customer Service at 855-476-1342 or email us at [email protected].

Recall details

Recall number
Z-2331-2026
Status
Open, Classified
Initiated by the company
Apr 13, 2026
Posted by the FDA
Jun 5, 2026
Recalling firm
HF Acquisition Co LLC
Quantity
2210
Product code
FRC
FDA submissions
K032914, K050591
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98695).

Sources and updates

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