Hf Acquisition Co Llc: Indicator, Biological Sterilization Process
Recall Summary SporeTraq Mail-In Spore Testing Service (52-test kits) used by healthcare facilities to verify sterilizer effectiveness is being recalled nationwide because the laboratory performed an incorrect incubation process when testing the returned spore strips. This means the test results may not accurately reflect whether sterilizers are working properly. The recall affects healthcare facilities across the United States that used this testing service.
- Recalling firm
- HF Acquisition Co LLC
- 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...
- Reason
- Due to incorrect incubation process being performed on product.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/79eacd8e-08e3-4282-8e4b-2e8ce7d80cdc