SporeTraq 52-test mail-in spore testing service used incorrect incubation
The SporeTraq Mail-In Spore Testing Service, 52 tests, is being recalled because an incorrect incubation process was performed on the product. 2,210 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a processing deviation in a testing service with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
The SporeTraq Mail-In Spore Testing Service, 52 tests, model/catalog number 1023780, from HF Acquisition Co LLC, is being recalled. The action covers 2,210 units.
The stated reason is that an incorrect incubation process was performed on the product. The recall notice identifies the required incubation periods that were not followed, including 24 hours for spore strips used in steam sterilizers and 72 hours for spore strips used in chemiclave sterilizers. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was nationwide in the United States across 41 states. The service is used by healthcare and dental practices rather than sold to consumers.
Practices should identify affected tests using the catalog number and the lot list in the recall notice and follow the instructions issued by the firm.
The recalled product
- 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 Strip
- Manufacturer
- HF Acquisition Co LLC
- Hazard
- process-deviation
- incorrect-incubation
- sterilization-monitoring
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 52 TESTS
- 1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22