# FDA recall Z-1141-2025

> **HF Acquisition Co LLC** · Class II · device recall initiated 2024-12-11.

## Product

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.  Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

## Reason for recall

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

## Distribution

US: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN, KS, SC, RI, LA, GA, PA, NH, UT, VA, MA, NV, MO, IL, SD, AR, OR, HI, NE, DC, CT, NM, ND, MT, OK, AL, VT, WY, KY, ME, IA, WV, AK

## Key facts

- **Recall number:** Z-1141-2025
- **Recalling firm:** HF Acquisition Co LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-11
- **Report date:** 2025-02-19

- **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-1141-2025

## Citation

> AI Analytics. FDA recall Z-1141-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1141-2025. Source: US FDA. Licensed CC0.

---

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