Biological — Class II medical device recall Z-1141-2025
Ongoing recall by HF Acquisition Co LLC, reported 2025-02-19, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a pri
| Recall number | Z-1141-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HF Acquisition Co LLC, Mukilteo, WA, United States |
| Recall initiated | 2024-12-11 |
| Classified | 2025-02-11 |
| Reported by FDA | 2025-02-19 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 4,021 |
| UPC / GTIN / UDI-DI | 10850065007813, 10850065007820 |
| Lot numbers | 1003600/10850065007820 |
| Model numbers | 1003580, 1003600 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1141-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.