Recall archive
88 recalls · page 3 of 4
Reported Aug 10, 2016
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The manufacturing and expiration dates are not printed on the blister pack label.
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
FDA (openFDA device enforcement)
Reported May 4, 2016
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Pilling Modular Verres Body/Obturator, Product Code 140880
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Arrow International, Inc., Division
Matched: Brand — The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to…
FDA (openFDA device enforcement)
Reported Dec 23, 2015
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
FDA (openFDA device enforcement)
Reported Nov 25, 2015
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2015
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr.,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand — The double swivel connector may crack or separate on the endobronchial tube.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2015
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand · Product details — The intake port may be blocked which can cause the bag to fail to fill.
FDA (openFDA device enforcement)
Reported May 6, 2015
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Customer complaints were received of power to the unit ceasing and the display going blank.
FDA (openFDA device enforcement)
Reported Apr 15, 2015
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
FDA (openFDA device enforcement)
Reported Feb 25, 2015
R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex, Inc.
Matched: Brand · Reason for recall — Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled…
FDA (openFDA device enforcement)
Reported Feb 18, 2015
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand — Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2014
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumed International, Inc.
Matched: Product details — The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976,…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2014
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2014
Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Brand · Product · Product details — The pediatric breathing circuits can crack prior to and during use.
FDA (openFDA device enforcement)
Reported Sep 24, 2014
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on…
FDA (openFDA device enforcement)
Reported Aug 13, 2014
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teleflex Medical
Matched: Brand · Product · Product details — Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly…
FDA (openFDA device enforcement)
Reported Aug 6, 2014
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2014
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand — The temperature probe does not properly connect to the temperature port.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex Medical
Matched: Brand · Product · Product details — The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.
14 more products in this recall
FDA (openFDA device enforcement)
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