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Acumedia Manufacturers, Inc.

United StatesFDA applicant, unverified

Devices
177
FDA recalls
8

What Acumedia Manufacturers, Inc. makes

Acumedia Manufacturers, Inc. produces microbiological culture media and transport media, including selective and differential agar plates, broths, and specialized mixtures for bacterial and fungal isolation, identification, and transport. Examples include bile salts mixtures, Sabouraud maltose agar, and Amies transport medium for clinical and laboratory use.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) database and comply with U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue177

Newest first, rows 151-177 of 177

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  • Columbia Ref K811729

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tryptone Azolecithin Tween Ref K811356

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Todd Hewitt Broth Ref K811339

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Xl Agar Base Ref K881572

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Staphylococcus Agar 10 Ref K833219

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ec Medium Ref K811333

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cooked Meat Medium Ref K881525

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mycological Agar W/Low Ph Ref K881549

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Yersinia Selective Agar Ref K833205

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Brilliant Green Agar Ref K811041

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Phenol Red Broth Base Ref K881551

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nutrient Broth Ref K811323

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • M-Green Yeast & Mold Broth Ref K811336

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • C.L.E.D. Medium Ref K832573

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Brilliant Green Agar W/Sulfadiazine Ref K881530

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Dextrose Ref K833214

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Sf Broth Ref K811331

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Vogel & Johnson Agar Ref K811039

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Casein Peptone, Low Vitamin Ref K881528

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Beef Extract Ref K833215

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Jh Peptone Agar Ref K833291

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nutrient Agar Ref K811138

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Casman Medium Base Ref K881527

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Base Agar Ref K832576

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Littman Agar Ref K881544

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Polypeptone Peptone Ref K811652

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sabouraud Liquid, Broth Modified Ref K811326

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 151-177 of 177

Showing 151-177 of 177

FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 8 recalls initiated by Acumedia Manufacturers, Inc., the earliest on 2015-09-11 and the most recent on 2018-08-02. By recorded status: 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

6 initiated before 2017

  • 2018

    • 2 Aug 2018 Z-0283-2019 Class III Terminated Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021. Distribution: Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico,…
      Full distribution text Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
    • 2 Aug 2018 Z-0284-2019 Class III Terminated The product is labeled with an incorrect expiration date. Distribution: US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.

  • 2016

    • 25 Sep 2016 Z-2221-2017 Class III Terminated Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. Distribution: Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
    • 8 Aug 2016 Z-2212-2017 Class III Terminated Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. Distribution: US in the state of IL
    • 22 Apr 2016 Z-1093-2017 Class II Terminated light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts. Distribution: Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH,…
      Full distribution text Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
    • 23 Mar 2016 Z-2213-2017 Class III Terminated Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018. Distribution: Worldwide - US Nationwide in the state of ME; in the country of ECUADOR

  • 2015

    • 30 Nov 2015 Z-2584-2017 Class II Terminated Contamination of product with possible Bacillus spp Distribution: Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
    • 11 Sep 2015 Z-2214-2017 Class III Terminated Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. Distribution: Worldwide - US Nationwide in the state IL and the country of COLOMBIA