Recall archive
88 recalls · page 4 of 4
Reported Jul 2, 2014
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product…
FDA (openFDA device enforcement)
Reported Jun 18, 2014
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 14, 2014
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2014
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product details · Reason for recall — The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The products are being recalled because they did not meet minimum diameter requirements.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2014
Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Complaints of leakage of insufflation gas through the device.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2014
Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The product may fail to achieve seal of right lung due to the cuff inflating to one side
FDA (openFDA device enforcement)
Reported Mar 5, 2014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand — The tracheal tube can kink during patient use.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Sterility cannot be guaranteed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Labeling inconsistency
FDA (openFDA device enforcement)
Reported May 1, 2013
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Sterile packaging may be compromised.
FDA (openFDA device enforcement)
Reported Apr 10, 2013
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Arrow International Inc.
Matched: Product · Product details — The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium…
FDA (openFDA device enforcement)
Reported Oct 24, 2012
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
FDA (openFDA device enforcement)
Reported Aug 22, 2012
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teleflex Medical
Matched: Brand · Product · Product details — Product is missing the label on the internal packaging.
FDA (openFDA device enforcement)
Reported Jul 25, 2012
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential…
FDA (openFDA device enforcement)
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