Mukilteo, WA, United States
HF Acquisition Co LLC recalls
6 recalls recorded since 2018, most recently on 13 April 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 April 2026
- Reason
- Due to incorrect incubation process being performed on product.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2331-2026, Z-2332-2026
- 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 Mai
- 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 Mai
Ongoing Class II Medical devices
- Recall started
- 11 December 2024
- Reason
- Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
- Distribution
- US: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN, KS, SC, RI, LA, GA, PA, NH, UT, VA, MA, NV, MO, IL, SD, AR, OR, HI, NE, DC, CT, NM, ND, MT, OK, AL, VT, WY, KY, ME, IA, WV, AK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1141-2025
- Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Terminated Class III Drugs
- Recall started
- 6 June 2023
- Terminated
- 27 February 2024
- Reason
- Labeling: Label Mix-up
- Distribution
- Distributed in TX, AZ and CA only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0870-2023
- GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Terminated Class III Drugs
- Recall started
- 17 June 2020
- Terminated
- 13 April 2021
- Reason
- TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
- Distribution
- The vials were distributed to one consignee located in CT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1392-2020
- Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
Terminated Class II Medical devices
- Recall started
- 5 June 2020
- Terminated
- 1 February 2022
- Reason
- A missing component (hand suction pump) in the emergency medical kits.
- Distribution
- US Nationwide distribution including in the states of TN and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2779-2020
- STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS
Terminated Class II Medical devices
- Recall started
- 4 June 2020
- Terminated
- 8 July 2022
- Reason
- Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
- Distribution
- U.S. Distribution: CA, FL, NY, AL, WA, CT, OH, MA, TX, NH, WI, ID, MN, DC, IL, MI, PA, MT, AK, NE, MD, CO, GA, VA, WY, MO, HI, SD, AR, TN, KS, ND, WV, NJ, OK, OR, ME, AZ, NC, OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2791-2020, Z-2790-2020, Z-2789-2020, Z-2788-2020
- STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
- STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
- STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
- HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing vari
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.