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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 101-150 of 177

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  • Ym Broth Ref K881571

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

  • Dermatophyte Test Medium Ref K881524

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

  • Lowenstein-Jensen Medium Base Ref K833220

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

  • Brucella Agar Modified Ref K833299

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

  • Gn Broth (Hajna) Ref K811354

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

  • Tryptic Soy Broth Ref K811050

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

  • Dcls Agar Ref K811736

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

  • Potato Dextrose Agar Ref K811322

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

  • Sabouraud Bhi Agar Ref K833300

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

  • Deoxycholate Lactose Agar Ref K833203

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

  • Cta Medium Ref K811735

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

  • Thioglycollate Gelatin Medium Ref K811335

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

  • Bile Esculin Azide Agar Ref K832571

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

  • Macconkey Agar, Plus Ref K842100

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

  • Eugonic Agar Ref K834206

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

  • Brain Heart Infusion Agar Ref K811654

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

  • Chapman Stone Medium Ref K881526

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

  • Brilliant Green Bile Broth 2% Ref K811057

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

  • Selenite Broth Ref K881576

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

  • Sabouraud Dextrose Agar, Emmons Ref K833296

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

  • Levin Eosin-Methylene Blue Agar Ref K811045

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

  • Middlebrook & Cohn 7H11 Agar Base Ref K834204

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

  • Blood Agar Base W/Low Ph Ref K881532

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

  • Azide Blood Agar Base Ref K811733

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

  • Lactose Ref K833210

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

  • Hemoglobin Powder Ref K811357

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

  • Eosin-Methylene Blue Agar Ref K811133

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

  • Tinsdale Agar Base Ref K881555

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

  • Extract Broth Ref K832570

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

  • Moeller Decarboxylase Broth Ref K833202

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

  • Streptosel Ref K881578

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

  • Phytone Yeast Extract Agar Ref K881573

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

  • Russell Double Sugar Agar Ref K881553

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

  • Columbia Cna Agar Ref K811137

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

  • Triple Sugar Iron Agar Ref K811044

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

  • Antibiotic Medium #19 Ref K881537

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

  • Yeast Extract Ref K811360

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

  • Mr-Vp Broth Ref K833208

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

  • Tryptone Ref K881557

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

  • Selective Streptococcus Agar Ref K881575

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

  • Phenylethanol Agar Ref K811324

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

  • Tryptose Phosphate Broth Ref K881563

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

  • Antibiotic Medium #10 Polymyxin Seed Agar Ref K881538

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

  • Sim Medium Ref K811330

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

  • Inhibitory Mold Agar Ref K881565

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

  • Mannital Salt Agar Ref K811037

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

  • Lysine Iron Agar Ref K811355

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

  • Infusion Broth Ref K832569

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

  • Antibiotic Medium #9 Polymyxin Base Agar Ref K881534

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

  • Sabouraud Dextrose Agar Ref K811325

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

Rows 101-150 of 177

Showing 101-150 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