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Teleflex LLC

Also registered as Teleflex, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3030236028

Devices
10
Registrations
FDA
FDA recalls
151139 ongoing

Catalogue10

Newest first, rows 1-10 of 10

Company details

FDA FEI number
3030236028
Address
9491 Winnetka Avenue, Brooklyn Park, MN, 55445

FDA recalls151

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

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 11
  • 2023 128
  • 2024 0
  • 2025 0
  • 2026 1

11 initiated before 2017

Showing the 10 most recent of 151 recalls.

  • 2026

    • 7 May 2026 Z-2639-2026 Class II Ongoing Due to out-of-specification, or potential out-of-specification, levels of endotoxins Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama.
      Submission number: K791871

  • 2023

    • 25 May 2023 Z-1827-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1828-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1829-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1830-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1831-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1832-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1833-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1834-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1835-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
Show the 25 most recent of 151 recalls

  • 2023

    • 25 May 2023 Z-1836-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1837-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1838-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1839-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1840-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1841-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1842-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1843-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1844-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K780900
    • 25 May 2023 Z-1845-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837
    • 25 May 2023 Z-1846-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837
    • 25 May 2023 Z-1847-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837
    • 25 May 2023 Z-1848-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837
    • 25 May 2023 Z-1849-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837
    • 25 May 2023 Z-1850-2023 Class I Ongoing Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. Distribution: US Nationwide distribution including Puerto Rico. Submission number: K961837

Frequently asked questions

How many devices does Teleflex LLC have in the registry?

The registry currently lists 10 devices for Teleflex LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Teleflex LLC's devices?

Among its 10 most recently registered devices, Teleflex LLC has devices listed in FDA 510(k) (10 devices).

What risk classes do Teleflex LLC's devices fall under?

Among its 10 most recently registered devices, the classes recorded for Teleflex LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Teleflex LLC?

FDA recall records list 151 recalls initiated by Teleflex LLC, the most recent initiated on 7 May 2026. 139 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 Teleflex LLC in the registry?

The most recently registered devices listed for Teleflex LLC include PERCUTANEOUS INTRODUCER KIT, CONCHASMART BREATHING CIRCUIT, ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set and PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET.

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

This is an FDA establishment record. No EUDAMED registration is known for this company.