Hf Acquisition Co Llc: Indicator, Biological Sterilization Process
Summary HF Acquisition Co LLC is recalling SporeTraq Mail-In Spore Testing Service (12-test kits) used by healthcare facilities to verify that their sterilization equipment is working properly. The recall affects units distributed nationwide because the laboratory is performing an incorrect incubation process when testing the returned spore strips, which could produce inaccurate results. This is a Class II recall, meaning use of the product could result in serious adverse health consequences or death.
- Recalling firm
- HF Acquisition Co LLC
- Product
- Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 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/38c15cf6-7b7e-4a55-baaf-e57189b34714