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Remel, Inc.

Active in EUDAMED
Also registered as Remel Co.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000044686 FEI 1924669

Remel, Inc. is a medical device manufacturer based in the United States, with 1,304 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class I and II; EU Class A and B) and 114 FDA recalls as of 12 Nov 2026.

Devices
1,304
Registrations
EUDAMEDFDA
FDA recalls
11417 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 1,144
  • FDA 510(k) 154
  • EUDAMED 115

A device listed in two registries counts in both.

Device classes
  • FDA Class I 1,115
  • FDA Class II 114
  • EU Class A 73
  • EU Class B 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000044686
  • FDA FEI 1924669
  • DUNS 065769564

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
Thermo Fisher Diagnostics B.V.NL

What Remel, Inc. makes

REMEL, Inc. manufactures in vitro diagnostic (IVD) products for microbiological testing, including differential and selective agar and broth culture media, antimicrobial susceptibility testing media, biological stains, culture medium controls, base ingredients for culture media, bacterial differentiation discs, and faecal specimen containers with fixatives. Notable examples include BACTIDROP KOH (10%) for fungal detection and Mycobacti-Loops for mycobacterial sample collection.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway and listed under the Unique Device Identifier (UDI) system. These products are intended for use in clinical and laboratory settings in the United States.

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

Catalogue1,304

Newest first, rows 1-50 of 1,304

Search and filter all 1,304 devices
Skip device list

  • Eric (Electronic Rapid Identification Compendium) Web Ref R8323600W

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Strep Selective II Agar R01859 Open recall

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

  • ^bm^ Pk/50 Oxidase Test R9055635

    Listed Registry: GUDID Class:I

  • ImmunoDOT Autoimmunity Panel 1 KT/100TST R2470940

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

  • ^CE^Liq Stuarts, Dual Swab 36mmPK/500 r9723120

    Listed Registry: GUDID Class:I

  • eSwab 2mL Reg Flock 500 KT/PK R723109

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

  • Spectra™ Candida Agar R01833

    Listed Registry: GUDID Class:I

  • Bacticard Strep Ref K936021

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

  • A.C.T. I Ref K965149

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

  • Bacticard E. Coli Ref K934986

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

  • Bactidrop Ninhydrin Ref K920971

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

  • Hippurate Disk Ref K801305

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

  • Coagulase Plasma Ref K792235

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

  • Gram Iodine Ref K871286

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

  • Bacticard Strep Ref K933514

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

  • Bactidrop Koh (10%) Ref K920970

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

  • Remel R01069

    Listed Registry: GUDID Class:I

  • Remel R40206

    Listed Registry: GUDID Class:I

  • Remel R064022

    Listed Registry: GUDID Class:I

  • Remel R02006

    Listed Registry: GUDID Class:I

  • Remel R04059

    Listed Registry: GUDID Class:I

  • Remel R060274

    Listed Registry: GUDID Class:I

  • Remel R01854

    Listed Registry: GUDID Class:I

  • Remel R01036

    Listed Registry: GUDID Class:I

  • Remel R061990

    Listed Registry: GUDID Class:I

  • Mycobacti-Loops R4702000

    Listed Registry: GUDID Class:I

  • Remel R01255

    Listed Registry: GUDID Class:I

  • Remel R08913

    Listed Registry: GUDID Class:I

  • Remel R061100

    Withdrawn Registry: GUDID Class:I

  • Remel R061919

    Listed Registry: GUDID Class:I

  • Remel R061150

    Listed Registry: GUDID Class:I

  • Remel R09626

    Listed Registry: GUDID Class:I

  • Remel R09652

    Withdrawn Registry: GUDID Class:I

  • Remel R060988

    Listed Registry: GUDID Class:I

  • Remel R062182

    Listed Registry: GUDID Class:I

  • Remel R02050

    Listed Registry: GUDID Class:I

  • Remel R21238

    Listed Registry: GUDID Class:I

  • Remel R21123

    Listed Registry: GUDID Class:I

  • Remel R40025

    Listed Registry: GUDID Class:I

  • Remel R08932

    Withdrawn Registry: GUDID Class:I

  • Remel R40235

    Listed Registry: GUDID Class:I

  • Remel R01048

    Listed Registry: GUDID Class:I

  • Remel R21120

    Listed Registry: GUDID Class:I

  • Remel R21281

    Listed Registry: GUDID Class:I

  • Remel R07300

    Withdrawn Registry: GUDID Class:I

  • Remel R08572

    Withdrawn Registry: GUDID Class:I

  • Remel R060162

    Listed Registry: GUDID Class:I

  • Remel R060370

    Listed Registry: GUDID Class:I

  • Remel R01061

    Withdrawn Registry: GUDID Class:I

  • Remel R20302

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

Rows 1-50 of 1,304

Showing 1-50 of 1,304

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000044686
FDA FEI number
1924669
DUNS number
065769564
EUDAMED status
Active
EUDAMED registered name
Remel, Inc.
EUDAMED abbreviated name
-
Registered address
12076, Santa Fe Trail Drive, 66215, Lenexa, Kansas, United States
Phone
8002556730
PRRC contact
Paul Sherlock(public in EUDAMED)

FDA recalls114

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

FDA recall records list 113 recalls initiated by REMEL, INC., the earliest on 2002-05-09 and the most recent on 2026-06-03. By recorded status: 17 ongoing and 96 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, electrical or power, performance or accuracy and manufacturing or quality process. 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 4
  • 2018 4
  • 2019 15
  • 2020 1
  • 2021 4
  • 2022 10
  • 2023 2
  • 2024 1
  • 2025 9
  • 2026 3

61 initiated before 2017

Showing the 10 most recent of 114 recalls.

  • 2026

    • 3 Jun 2026 Z-2623-2026 Class II Ongoing Reduced or no recovery of some strains of Neisseria gonorrhoeae. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom. Submission number: K954986
    • 24 Mar 2026 Z-1806-2026 Class II Ongoing Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
      Submission number: K090968
    • 5 Feb 2026 Z-1474-2026 Class II Ongoing Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. Distribution: US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.

  • 2025

    • 12 Nov 2025 Z-0585-2026 Class II Ongoing Products may contain contamination, which may result in a darker or brown media color. Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.
      Submission numbers: K790687, K802957
    • 11 Jul 2025 Z-2223-2025 Class II Ongoing The products may contain surface and subsurface contamination of Listeria monocytogenes. Distribution: US Nationwide distribution.
    • 11 Jul 2025 Z-2224-2025 Class II Ongoing The products may contain surface and subsurface contamination of Listeria monocytogenes. Distribution: US Nationwide distribution. Submission number: K843193
    • 11 Jul 2025 Z-2225-2025 Class II Ongoing The products may contain surface and subsurface contamination of Listeria monocytogenes. Distribution: US Nationwide distribution.
    • 11 Jul 2025 Z-2226-2025 Class II Ongoing The products may contain surface and subsurface contamination of Listeria monocytogenes. Distribution: US Nationwide distribution.
    • 1 May 2025 Z-1947-2025 Class II Ongoing Product may have an off color affecting perfomance Distribution: Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK. Submission number: K111429
    • 13 Feb 2025 Z-1200-2025 Class II Ongoing Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. Distribution: US Nationwide distribution.
Show the 25 most recent of 114 recalls

  • 2025

    • 13 Feb 2025 Z-1201-2025 Class II Ongoing Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. Distribution: US Nationwide distribution.
    • 12 Feb 2025 Z-1395-2025 Class II Ongoing Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. Distribution: Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution…
      Full distribution text Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas.
      Submission number: K191918

  • 2024

    • 20 Sep 2024 Z-0266-2025 Class II Ongoing A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results. Distribution: Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military…
      Full distribution text Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.
      Submission number: K920974

  • 2023

    • 14 Aug 2023 Z-2531-2023 Class II Ongoing On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples Distribution: US Nationwide Distribution Submission number: K871447
    • 31 May 2023 Z-2038-2023 Class II Ongoing The test medium may not perform as intended. Distribution: Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution. Submission number: K892928

  • 2022

    • 20 Oct 2022 Z-0327-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0328-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0329-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0330-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0331-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0332-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0333-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0334-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 20 Oct 2022 Z-0335-2023 Class I Terminated An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. Distribution: US Nationwide Distribution Submission numbers: K880641, K060621, K073424, K860753, K936305, K983244
    • 10 Jan 2022 Z-0722-2022 Class II Terminated There are lower than expected MICs for some gram negative species. Distribution: Distribution throughout the United States. Submission number: K193538

Frequently asked questions

How many devices does REMEL, INC. have in the registry?

The registry currently lists 1304 devices for REMEL, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list REMEL, INC.'s devices?

Among its 50 most recently registered devices, REMEL, INC. has devices listed in EUDAMED (1 device), FDA 510(k) (9 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do REMEL, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for REMEL, INC.'s devices are Class I, Class II and IVDR Class B. Each device page shows its own class and authorisation.

Are there FDA recall records for REMEL, INC.?

FDA recall records list 114 recalls initiated by REMEL, INC., the most recent initiated on 3 Jun 2026. 17 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from REMEL, INC. in the registry?

The most recently registered devices listed for REMEL, INC. include ERIC (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) WEB, Strep Selective II Agar R01859, ^BM^ PK/50 OXIDASE TEST R9055635 and ImmunoDOT Autoimmunity Panel 1 KT/100TST R2470940.

Generated automatically from registry data and not verified by a human reviewer.