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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 51-100 of 177

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  • Cary And Blair Transport Medium Ref K881529

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

  • Brain Heart Infusion W/O Dextrose Ref K811353

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

  • Mueller Hinton Broth Ref K811136

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

  • Bismuth Sulfite Agar Ref K811043

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

  • Blood Agar Base No. 2 Ref K881533

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

  • Bile Esculin Agar Ref K832572

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

  • Brucella Broth Ref K811734

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

  • Acidicase-BB1 Ref K833209

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

  • Dextrose Agar Ref K881522

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

  • Dextrose Tryptone Broth Ref K881523

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

  • Standard Method Broth Ref K833217

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

  • Mitis Salivarius Agar Ref K881547

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

  • Stuarts Transport Medium Ref K881569

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

  • Coba Agar Ref K842101

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

  • Standard Methods Agar Ref K811321

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

  • Tryptic Soy Agar W/Lecithin & Tween 80 Ref K811052

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

  • Macconkey Agar Ref K811048

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

  • Tryptic Soy Agar Ref K811051

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

  • Antibiotic Medium #6 Ref K881535

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

  • Lactose Broth Ref K811130

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

  • Yeast Beef Agar-Antibiotic MED.4 Ref K833218

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

  • Seed Agar Ref K832577

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

  • Blood Agar Base, Improved Ref K881531

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

  • Sterility Test Broth Ref K811046

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

  • Columbia Blood Agar Base Ref K811135

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

  • Indole Nitrate Medium Ref K832568

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

  • Tryptose Blood Agar Base W/Yeast Extract Ref K881564

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

  • Tergitol 7 Broth Ref K881561

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

  • Btb Lactose Agar Ref K832574

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

  • Macconkey Broth Ref K811650

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

  • Proteose No. 3 Agar Ref K881552

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

  • Motility Test Medium Ref K833216

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

  • Ak Agar 2 Ref K833207

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

  • Trypticase Ref K811651

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

  • Mycosel Ref K811334

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

  • Salmonella Shigella Agar Ref K811327

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

  • Antibiotic Assay Broth Ref K832575

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

  • Hemoglobin Powder Ref K881566

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

  • Urea Broth Ref K881560

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

  • Heart Infusion Agar Ref K881542

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

  • Simmons Citrate Agar Ref K833201

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

  • Xld Agar Ref K811042

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

  • Pancreatic Hydrolysate Of Heart Muscle Ref K811361

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

  • Phytone Ref K811653

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

  • Tryptose Blood Agar Base Ref K881562

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

  • Letheen Agar Ref K881543

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

  • Endo Agar Ref K811648

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

  • Brucella Agar Ref K811128

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

  • Mueller Hinton Agar Ref K811049

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

  • Skim Milk Dehydrated Ref K881554

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

Rows 51-100 of 177

Showing 51-100 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