CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Sporetraq Mail-in Spore Testing Service, 12 Tests recalled

HF Acquisition Co is recalling Sporetraq Mail-in Spore Testing Service, 12 Tests, distributed nationwide in the US. The recall was initiated on 13 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the previous recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2332-2026
FDA event ID: 98695
Recalling firm: HF Acquisition Co, Mukilteo, WA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Apr 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Insulin Pumps & Glucose Monitors

Timeline

13 Apr 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+53 days
17 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to incorrect incubation process being performed on product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 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

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Stores named: Online Retailers

Questions about this recall

Is Sporetraq Mail-in Spore Testing Service, 12 Tests recalled?

Yes. HF Acquisition Co recalled Sporetraq Mail-in Spore Testing Service, 12 Tests on 13 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2332-2026.

Why was it recalled?

Due to incorrect incubation process being performed on product.

Which lots are affected?

Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the previous recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from HF Acquisition Co

All 10

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Sporetraq Mail-in Spore Testing Service, 52 Tests recalled	HF Acquisition Co	Sterility	Nationwide
19 Feb 2025Device	CLASS II	Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests recalled	HF Acquisition Co	Sterility	50 states
14 Jun 2023Drug	CLASS III	Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate	HF Acquisition Co	Packaging Defects	AZ, CA, TX
19 Aug 2020Device	CLASS II	HealthFirst Emergency Medical Kit recalled by HF Acquisition Co	HF Acquisition Co	Packaging Defects	39 states
19 Aug 2020Device	CLASS II	STAT KIT Z-1000 emergency medical kit HealthFirst recalled	HF Acquisition Co	Other	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 459

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Lead & Heavy Metals	Nationwide
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Lead & Heavy Metals	Nationwide