What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed in FDA's full record)) and recall.

Has HF Acquisition Co LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to HF Acquisition Co LLC, including 2 recalls and 0 warning letters.

FDA Recall Database: Class II Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… by HF Acquisition Co LLC

HF Acquisition Co LLC recalled 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 (additional items listed in FDA's full record) on 2026-06-17. FDA classified this action as a Class II recall (recall number Z-2331-2026). Reason for recall: Due to incorrect incubation process being performed on product.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	HF Acquisition Co LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	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 sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
Classification	Class II
Recall number	Z-2331-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to incorrect incubation process being performed on product.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is HF Acquisition Co LLC and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to incorrect incubation process being performed on product.. The recall is tracked under FDA recall number Z-2331-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2331-2026. If it matches, stop using or distributing it and contact HF Acquisition Co LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

HF Acquisition Co LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to HF Acquisition Co LLC: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed in FDA's full record)) and recall.
Has HF Acquisition Co LLC had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to HF Acquisition Co LLC, including 2 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2331-2026.

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Full FDA history for HF Acquisition Co LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… by HF Acquisition Co LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-hf-acquisition-co-llc-z-2331-2026

MLA

"FDA Recall Database: Class II Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… by HF Acquisition Co LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-hf-acquisition-co-llc-z-2331-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… by HF Acquisition Co LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-hf-acquisition-co-llc-z-2331-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_hf_acquisition_co_llc_z_2331_2026_2026,
  title = {FDA Recall Database: Class II Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52… by HF Acquisition Co LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-hf-acquisition-co-llc-z-2331-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗