PlainRecalls

Teleflex Medical

135 recalls on record · Latest: Jan 22, 2020

FDA Devices Low Jan 22, 2020

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

FDA Devices Moderate Nov 27, 2019

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are deliv…

FDA Devices Moderate Nov 27, 2019

WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o…

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 …

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) …

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e…

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-…

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-104…

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management

FDA Devices Critical Sep 18, 2019

Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Trache…

FDA Devices Moderate Aug 7, 2019

Rusch EasyCath Kit

FDA Devices Low Jul 24, 2019

RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) E…

FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5…

FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, P…

FDA Devices Critical Jun 26, 2019

Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management

FDA Devices Critical Jun 26, 2019

Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management

FDA Devices Moderate Jun 5, 2019

RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0

FDA Devices Moderate Jun 5, 2019

RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

FDA Devices Moderate Jun 5, 2019

RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0

FDA Devices Moderate Feb 27, 2019

Pilling COOLEY SUMP-SUCTION TUBE, REF 351547

FDA Devices Moderate Apr 4, 2018

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

FDA Devices Moderate Mar 7, 2018

Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

FDA Devices Moderate Nov 15, 2017

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

FDA Devices Moderate Oct 25, 2017

Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which ar…

FDA Devices Moderate Oct 4, 2017

Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to…

FDA Devices Moderate Oct 4, 2017

Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to ac…

FDA Devices Moderate Oct 4, 2017

Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain a…

FDA Devices Moderate Oct 4, 2017

Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to acc…

FDA Devices Moderate Oct 4, 2017

Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access ce…

FDA Devices Moderate Jun 21, 2017

Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coat…

FDA Devices Moderate Jun 14, 2017

Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,

FDA Devices Moderate May 31, 2017

PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

FDA Devices Moderate May 31, 2017

PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

FDA Devices Moderate May 24, 2017

WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on …

FDA Devices Low Apr 26, 2017

Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

FDA Devices Moderate Feb 15, 2017

Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a pat…

FDA Devices Moderate Dec 28, 2016

Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD1…

FDA Devices Moderate Dec 28, 2016

LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, …

FDA Devices Moderate Dec 28, 2016

LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, phar…

FDA Devices Moderate Dec 28, 2016

LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia…

FDA Devices Moderate Dec 28, 2016

RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization

FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration S…

FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the v…

FDA Devices Moderate Dec 7, 2016

OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiratio…

FDA Devices Critical Oct 26, 2016

Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen …

FDA Devices Moderate Sep 7, 2016

MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

FDA Devices Moderate Aug 24, 2016

Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repai…

FDA Devices Moderate Aug 17, 2016

Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be po…

FDA Devices Moderate Aug 10, 2016

Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures i…