Data / Medical devices / Ireland / Teleflex Medical

Teleflex Medical: FDA-registered device maker in ATHLONE Westmeath, Ireland, 5 510(k) clearances

Name: Teleflex Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Teleflex Medical is registered with the FDA (registration 3007134520) in ATHLONE Westmeath, Ireland. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 23, 2026. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007134520
Address: Ida Business And Technology Park Dublin Road, ATHLONE Westmeath, Ireland, --
Owner or operator: Teleflex (9062981)
Roles: Manufacturer, Specification developer
First device listed: November 5, 2012
Registered through: 2027
Brand names listed: EZ-BLOCKER, Liquick X-treme, Liquick X-treme Plus, Rusch Endobronchial Tubes, Rusch FloCath Quick 18 Fr. Coude Hydrophilic Intermittent Catheter, Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Straight	EZD	2	Specification developer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Specification developer	accessdata.fda.gov
Catheter, Urological	KOD	2	Specification developer	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 23, 2026	K261418	Liquick X-treme, Liquick X-treme Plus	EZD	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
May 24, 2019	K181979	Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter	KOD	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
May 8, 2019	K183461	Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter	GBM	Unknown	Teleflexmedical, Inc.	accessdata.fda.gov
April 15, 2015	K141888	RUSCH ENDOBRONCHIAL TUBES	CBI	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
September 28, 2012	K121462	EZ-BLOCKER	CBI	Substantially Equivalent	Ez-Blocker B.V.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 16, 2021	88353	Class II	Terminated	RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095	The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.	accessdata.fda.gov
June 12, 2018	80279	Class II	Terminated	Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors	The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.	accessdata.fda.gov
March 27, 2018	79670	Class II	Terminated	Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.	These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.	accessdata.fda.gov
March 19, 2018	79643	Class II	Terminated	Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region	Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.	accessdata.fda.gov
March 15, 2018	79579	Class II	Terminated	Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h)	These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.	accessdata.fda.gov
May 12, 2015	71247	Class II	Terminated	T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation	Potential breach in sterility	accessdata.fda.gov
March 31, 2014	67912	Class II	Terminated	EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455	The voluntary recall is due to the needle set not meeting its specifications.	accessdata.fda.gov

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Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.