Recall Register

TELEFLEX MEDICAL INC: FDA recalls

FDA enforcement reports name TELEFLEX MEDICAL INC as the recalling firm in 12 events. The events have 32 product records. The recalls started from 2019 to 2022. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

12 events, newest first.

FDA enforcement events of TELEFLEX MEDICAL INC
InitiatedProduct (first record)TypeClassRecordsStatus
11 Apr 2022(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck…DeviceClass II2Ongoing
11 Jan 2022Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV)…DeviceClass I7Terminated
18 Feb 2021RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.DeviceClass II1Terminated
12 Feb 2021PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar…DeviceClass II1Terminated
7 Aug 2020Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.DeviceClass II1Terminated
6 Jul 2020Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.DeviceClass II7Terminated
30 Jun 2020Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure…DeviceClass II2Terminated
29 May 2020RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in…DeviceClass II1Terminated
13 Jan 2020Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440DeviceClass II2Terminated
9 Jan 2020Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemDeviceClass II2Terminated
13 Dec 2019HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kitDeviceClass I4Terminated
11 Oct 2019Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography…DeviceClass II2Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

TELEFLEX MEDICAL INC: events for each product type
TypeEvents
Device12
TELEFLEX MEDICAL INC: events in each class
ClassEvents
Class II10
Class I2
Share of the events of the firm in Class I
17%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of TELEFLEX MEDICAL INC, by the year that the recall started. The largest year is 2020, with 6 events.

Official channels

Cite this page

Recall Register. TELEFLEX MEDICAL INC: FDA recalls. https://recallregister.com/firm/teleflex-medical-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NC

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of TELEFLEX MEDICAL INC have?
Class II: 10 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of TELEFLEX MEDICAL INC?
FDA event 90014, which the firm started on 11 Apr 2022. The first product in the record is: (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck…
How many FDA recalls of TELEFLEX MEDICAL INC have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.