Recall archive
88 recalls · page 1 of 4
Reported Nov 23, 2022
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
Matched: Brand · Product · Product details — Product may not be sterile
FDA (openFDA device enforcement)
Reported Jun 1, 2022
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand — Reports received of torn corrugated breathing tubes.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical Inc.
Matched: Brand — The firm received reports indicating PTD tip separation during use.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
Matched: Brand — The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 31, 2021
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand · Reason for recall — Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2020
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand — Potential sterility issue
FDA (openFDA device enforcement)
Reported Aug 12, 2020
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand — Potential for sterile packaging to be compromised¿
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2020
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand — Breaking at the point of a welded joint
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand · Reason for recall — Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand · Product · Product details · Reason for recall — Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Inc.
Matched: Brand — There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2020
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical Inc.
Matched: Brand — There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2020
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teleflex Medical
Matched: Brand · Product · Product details — The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2019
Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product details — The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2019
WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported 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…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand · Reason for recall — Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2019
Rusch EasyCath Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Potential for product not to be sterile.
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand · Product · Product details — Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand — This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2019
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2019
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The internal tip is missing from the device, causing the device to not function as intended.
FDA (openFDA device enforcement)
Reported Jan 30, 2019
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2018
Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
Matched: Brand · Product · Product details — The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.
FDA (openFDA device enforcement)
Reported May 9, 2018
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical Europe Ltd.
Matched: Brand · Product · Product details · Reason for recall — Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
FDA (openFDA device enforcement)
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