FDA Device recall Z-1141-2025
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600 by Hf Acquisition, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1141-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-11 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hf Acquisition |
| Distribution | 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 |
Product
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Reason
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.
Identifiers
| code_info | Item/UDI-DI/Lot(Expiration): 1003600/10850065007820/ 2301060(11/30/2024) 2302261(11/30/2024) 2307261(12/31/2024 2312260…Item/UDI-DI/Lot(Expiration): 1003600/10850065007820/ 2301060(11/30/2024) 2302261(11/30/2024) 2307261(12/31/2024 2312260(1/31/2025) 2313062(1/31/2025) 2331880(6/30/2025) 2401664(8/31/2025) 2414060(2/28/2026) 2414862(3/31/2026) 2414870(3/31/2026) 2416470(3/31/2026) 2416481(4/30/2026) 2416482(4/30/2026) 1003580/10850065007813/2421181(5/31/2026) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1141-2025%22
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