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Stradis Healthcare

Country not established

Devices
1
FDA recalls
7119 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Stradis Healthcare makes

Stradis Healthcare manufactures the Unger Quad Injector, a medical device designed for precise multi-channel drug or fluid administration in clinical settings.

The Unger Quad Injector is classified as a Class II device under FDA regulations and is listed in the FDA’s 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.

Catalogue1

Newest first, rows 1-1 of 1

  • Unger Quad Injector Ref K161483

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

FDA recalls71

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 71 recalls initiated by Stradis Healthcare, the earliest on 2015-04-20 and the most recent on 2022-12-15. By recorded status: 19 ongoing, 1 terminated and 51 with another status. The reasons filed fall into these groups: sterility or contamination, packaging, mechanical integrity 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 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 20
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

51 initiated before 2017

Showing the 10 most recent of 71 recalls.

  • 2022

    • 15 Dec 2022 Z-0931-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0932-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0933-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0934-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0935-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0936-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. Submission number: K190328
    • 15 Dec 2022 Z-0937-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. Submission number: K190328
    • 15 Dec 2022 Z-0938-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. Submission number: K102969
    • 15 Dec 2022 Z-0939-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. Submission number: K102969
    • 15 Dec 2022 Z-0940-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Show the 25 most recent of 71 recalls

  • 2022

    • 15 Dec 2022 Z-0941-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0942-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0943-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0944-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0945-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0946-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0947-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 15 Dec 2022 Z-0948-2023 Class II Ongoing Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
    • 10 May 2022 Z-1688-2022 Class II Ongoing Potential for incomplete seals. Distribution: Pennsylvania
    • 22 Apr 2022 Z-1132-2022 Class II Terminated There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. Distribution: US Distribution to NC.

  • 2015

    • 20 Apr 2015 Z-1992-2015 Class II Completed Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Distribution: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC,…
      Full distribution text Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
    • 20 Apr 2015 Z-1993-2015 Class II Completed Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Distribution: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC,…
      Full distribution text Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
    • 20 Apr 2015 Z-1994-2015 Class II Completed Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Distribution: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC,…
      Full distribution text Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
    • 20 Apr 2015 Z-1995-2015 Class II Completed Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Distribution: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC,…
      Full distribution text Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
    • 20 Apr 2015 Z-1996-2015 Class II Completed Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Distribution: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC,…
      Full distribution text Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

Frequently asked questions

How many devices does Stradis Healthcare have in the registry?

The registry currently lists 1 device for Stradis Healthcare. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stradis Healthcare's devices?

Among its 1 most recently registered device, Stradis Healthcare has devices listed in FDA 510(k) (1 device).

Are there FDA recall records for Stradis Healthcare?

FDA recall records list 71 recalls initiated by Stradis Healthcare, the most recent initiated on 15 Dec 2022. 19 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 Stradis Healthcare in the registry?

The most recently registered devices listed for Stradis Healthcare include Unger Quad Injector.

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