Teleflex Medical
Teleflex Medical holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2025, with 204 FDA device recalls on record.
Top product codes for Teleflex Medical
FDA recalls by Teleflex Medical
10 most recent of 204- Z-0703-2020 — HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
- Z-0689-2020 — Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
- Z-0688-2020 — Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
- Z-0690-2020 — Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
- Z-0497-2020 — WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
- Z-0496-2020 — WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
- Z-2313-2019 — 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 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management
- Z-2315-2019 — 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 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 Product Usage: Tracheal tube/airway management
- Z-2316-2019 — 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) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management
- Z-2317-2019 — Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Teleflex Medical
- K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips
- K242495 — LMA Fastrach ETT SU
- K243553 — QuikClot Control+ Hemostatic Device
- K241784 — Arrow® Nitinol Wire
- K233713 — Pilling Tracheostomy Tubes
- K232970 — Hem-o-lok® Ligating Clips
- K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more
- K231924 — EZ-IO Intraosseous Vascular Access System
- K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
- K222279 — Rusch Intermittent Urethral Catheters
- K202492 — EZ-IO Intraosseous Vascular Access System
- K192490 — Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
- K193530 — Deklene MAXX
- K190026 — Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
- K180253 — Sheridan Endobronchial Tubes
- K173321 — StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle
- K180588 — FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
- K173596 — Rusch Intermittent Urethral Catheters
- K161758 — Weck Auto Endo10 Automatic Endoscopic Clip Applier
- K153470 — MADgic Laryngo-Tracheal Mucosal Atomization Device
- K133202 — HEM-O-LOK LIGATING CLIP
- K132658 — HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
- K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
- K112958 — HUMID-VENT HEPA
- K100506 — FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
- K082156 — ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
- K070561 — KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
- K063758 — CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
- K063778 — FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
- K062914 — HEM-O-LOK LIGATION CLIP
- K061736 — COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
- K060801 — DEKNA-LOK MODEL BP1000V2L
- K060519 — INTRODUCER ASSEMBLY WITH ROTATOR LOCK
- K043205 — RUSCH EASY TUBE
- K043258 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
- K042141 — POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
- K040472 — FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
- K033654 — FORCE FIBER
- K033115 — ORTHODEK
Data sourced from openFDA. This site is unofficial and independent of the FDA.