RegWardenFDA facility compliance records
Company

Teleflex

41 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 3 recalls; 2015: 2 recalls; 2016: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2019: 13 recalls; 2020: 6 recalls; 2021: 2 recalls; 2022: 6 recalls; 2023: 4 recalls; 2026: 1 recalls1’133’142’151’161’171’1813’196’202’216’224’23’24’251’26
  • Recalls (41)

Registered facilities (9)

Recalls & enforcement

20261 record
20234 records
  • Class IOngoing2023-05-25
    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
  • Class IIOngoing2023-05-25
    There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
  • Class IIOngoing2023-04-28
    Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a mor…
  • Class IIOngoing2023-04-12
    The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
20226 records
20212 records
  • Class IITerminated2021-02-18
    Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
  • Class IITerminated2021-02-12
    Teleflex is recalling this product due to a lack of assurance of sterility.
20206 records
201913 records
  • Class ITerminated2019-12-13
    There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
  • Class IITerminated2019-10-30
    The tracheal and brochial swivel connectors are incorrectly labeled.
  • Class IIOngoing2019-10-11
    Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas…
  • Class IIOngoing2019-10-08
    The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury t…
  • Class IIOngoing2019-10-04
    Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partia…
  • Class ITerminated2019-07-30
    Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
  • Class IITerminated2019-07-01
    Potential for product not to be sterile.
  • Class ITerminated2019-06-14
    Device vented gas below the stated pressure.
  • Class ITerminated2019-05-24
    This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
  • Class ITerminated2019-05-10
    Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
  • Class IITerminated2019-04-01
    The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
  • Class IIITerminated2019-02-27
    The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to b…
  • Class IIITerminated2019-01-14
    The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
20181 record
  • Class IITerminated2018-01-03
    There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be r…
20171 record
  • Class IITerminated2017-07-19
    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
20161 record
20152 records
20143 records
  • Class IITerminated2014-12-12
    Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.
  • Class ITerminated2014-12-04
    Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health conseque…
  • Class IITerminated2014-11-21
    Customer complaints reporting that the cobb connector detached from the main connector prior to use.
20131 record

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Teleflex — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9062981-teleflex/

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