FDA Medical devices recall ·
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests… recall
- Recall number
- Z-1141-2025
- Date
- (initiated December 11, 2024)
- Company / brand
- HF Acquisition Co LLC
11629 49th Pl W, Mukilteo, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,021
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
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
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1141-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.