Santa Maria, CA, United States
Hardy Diagnostics recalls
7 recalls recorded since 2018, most recently on 8 June 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2887-2026
- HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enter
Ongoing Class II Medical devices
- Recall started
- 6 May 2025
- Reason
- Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
- Distribution
- US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2041-2025
- HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 28 July 2022
- Reason
- Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1835-2021
- Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Terminated Class II Medical devices
- Recall started
- 21 December 2020
- Terminated
- 28 September 2022
- Reason
- Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
- Distribution
- U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0919-2021
- Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 20 September 2022
- Reason
- There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
- Distribution
- US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0655-2021
- Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimen
Terminated Class III Medical devices
- Recall started
- 6 October 2020
- Terminated
- 28 May 2021
- Reason
- Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
- Distribution
- US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0441-2021
- Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Terminated Class II Medical devices
- Recall started
- 14 November 2019
- Terminated
- 28 April 2021
- Reason
- False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
- Distribution
- U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2298-2020
- HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to di
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.