Browse Device Recalls

712 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 712 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 712 FDA device recalls in NC.

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Date	Product	Reason	Class	Firm
Jan 14, 2015	AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier ...	The packages may contain foreign material (black particles).	Class II	Teleflex Medical
Jan 13, 2015	LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, ...	The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New...	Class II	Teleflex Medical
Jan 12, 2015	MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01...	Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm I...	Class I	Teleflex Medical
Jan 9, 2015	Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,...	Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T...	Class II	Teleflex Medical
Jan 8, 2015	Pilling Modular Verres Body/Obturator, Product Code 140880	Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a...	Class II	Teleflex Medical
Dec 3, 2014	WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating C...	The manufacturing dates and expiration dates were transposed on the Tyvek label.	Class II	Teleflex Medical
Nov 20, 2014	UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are in...	Failure to submit a 510(k) for device labeling changes.	Class II	Unistrip Technologies LLC
Nov 12, 2014	Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Researc...	Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube...	Class II	Teleflex Medical
Nov 10, 2014	Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Nov 10, 2014	Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Oct 23, 2014	ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for:...	Some of vials were found to be partially filled.	Class II	TEM Systems Inc
Sep 26, 2014	Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open...	Distortion (noise interference) of the liquid level capacitance can result in air aspiration inst...	Class II	Tecan US, Inc.
Sep 26, 2014	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) RE...	The knife handles slot depth is out of specification, so blades may not fit on the handles properly.	Class II	Teleflex Medical
Sep 8, 2014	Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx ...	The pediatric breathing circuits can crack prior to and during use.	Class I	Teleflex Medical
Sep 4, 2014	Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile....	Misbranding: Although the product labeling identifies the catheters as "soft rubber," t...	Class II	Teleflex Medical
Sep 3, 2014	Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB...	Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the...	Class II	Teleflex Medical
Sep 3, 2014	Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 102...	Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the...	Class II	Teleflex Medical
Jul 10, 2014	RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S...	Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date...	Class III	Teleflex Medical
Jul 9, 2014	Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscop...	Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates ...	Class II	Teleflex Medical
Jul 9, 2014	Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Pie...	The temperature probe does not properly connect to the temperature port.	Class II	Teleflex Medical
Jul 9, 2014	Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory...	The temperature probe does not properly connect to the temperature port.	Class II	Teleflex Medical
Jun 30, 2014	RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, N...	There is a possibility the handle of the laryngoscope may heat up and melt the end cap.	Class II	Teleflex Medical
Jun 15, 2014	Paragon Laboratory Management	For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 201...	Class II	McKesson Technologies, Inc.
Jun 12, 2014	McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 12, 2014	Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20...	Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.	Class II	Medical Action Industries Inc
Jun 5, 2014	Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory ...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory g...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas h...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respi...	The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentiall...	Class II	Teleflex Medical
Jun 5, 2014	Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier ...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory ga...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humid...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humi...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas ...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
Jun 5, 2014	Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respi...	The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.	Class II	Teleflex Medical
May 23, 2014	RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Me...	Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the ...	Class II	Teleflex Medical
May 21, 2014	RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex ...	Product was packaged with a straight catheter rather than the correct coude (curved) catheter.	Class II	Teleflex Medical
May 16, 2014	Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate ...	Several complaints were received for the metal support tube missing from the cholangiogram catheter.	Class II	Teleflex Medical
Apr 17, 2014	Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RC...	Product is being recalled due to complaints that the inspiratory and expiratory tubes are transpo...	Class II	Teleflex Medical

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.