# FDA recall Z-2331-2026

> **HF Acquisition Co LLC** · Class II · device recall initiated 2026-04-13.

## 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

## Reason for recall

Due to incorrect incubation process being performed on product.

## 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.

## Key facts

- **Recall number:** Z-2331-2026
- **Recalling firm:** HF Acquisition Co LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-13
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mukilteo, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2026

## Citation

> MORVS. FDA recall Z-2331-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2331-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*