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Madison Polymeric Engineering

Country not established

Devices
2
FDA recalls
11

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Madison Polymeric Engineering makes

Madison Polymeric Engineering manufactures electrosurgical tip cleaners and instrument protectors.

These products are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls11

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

FDA recall records list 11 recalls initiated by Madison Polymeric Engineering, the earliest on 2017-04-17 and the most recent on 2019-05-08. By recorded status: 11 terminated. The reasons filed fall into these groups: sterility or contamination. 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 2
  • 2018 7
  • 2019 2
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 11 recalls.

  • 2019

    • 8 May 2019 Z-1924-2019 Class II Terminated This product has been contaminated with Stenotrophomonas lactiubi. Distribution: The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.
    • 8 May 2019 Z-1925-2019 Class II Terminated This product has been contaminated with Stenotrophomonas lactiubi. Distribution: The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.

  • 2018

    • 14 Dec 2018 Z-0969-2019 Class II Terminated The product is contaminated with Pseudomonas. Distribution: Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following…
      Full distribution text Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
    • 21 Mar 2018 Z-1895-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
    • 21 Mar 2018 Z-1896-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
    • 21 Mar 2018 Z-1897-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
    • 21 Mar 2018 Z-1898-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
    • 21 Mar 2018 Z-1899-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
    • 21 Mar 2018 Z-1900-2018 Class II Terminated The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA,…
      Full distribution text The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.

  • 2017

    • 3 Nov 2017 Z-1182-2018 Class II Terminated Affected lots may have exceeded its microbial limits. Distribution: US Distribution. .
Show all 11 recalls

  • 2017

    • 17 Apr 2017 Z-2211-2017 Class II Terminated Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. Distribution: Distributed in the US.

Frequently asked questions

How many devices does Madison Polymeric Engineering have in the registry?

The registry currently lists 2 devices for Madison Polymeric Engineering. Devices recorded under merged duplicate company entries are counted once.

Which registries list Madison Polymeric Engineering's devices?

Among its 2 most recently registered devices, Madison Polymeric Engineering has devices listed in FDA 510(k) (2 devices).

What risk classes do Madison Polymeric Engineering's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Madison Polymeric Engineering's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Madison Polymeric Engineering?

FDA recall records list 11 recalls initiated by Madison Polymeric Engineering, the most recent initiated on 8 May 2019. 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 Madison Polymeric Engineering in the registry?

The most recently registered devices listed for Madison Polymeric Engineering include CYGNUS ELECTROSURGICAL TIP CLEANER and CYGNUS INSTRUMENT PROTECTORS.

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