Browse Device Recalls

352 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 352 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 352 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 8, 2014	Lock nuts for titanium traction tongs are used in traction skull tongs for tr...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Hudson braces are bone cutting and drilling instruments that are used without...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Replacement screw non-springloaded traction tongs are skull tongs for tractio...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Traction tong replacement screws, non-springloaded are used in traction skull...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Manual trephines are bone cutting and drilling instruments that are used with...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	An external vein stripper is an extravascular device used to remove a section...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	A trocar is a sharp-pointed instrument used with a cannula for piercing a ves...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Hudson burrs are bone cutting and drilling instruments that are used without ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Galt trephines are bone cutting and drilling instruments that are used withou...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Titanium fixation screws, springloaded are used in traction skull tongs for t...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	CVB distraction screws are bone cutting and drilling instruments that are use...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Cushing perforating drills are bone cutting and drilling instruments that are...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Cloward Spanner gauges are bone cutting and drilling instruments that are use...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Gardner-Wells wrenches are used in traction skull tongs for traction used to ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	McKenzie Perforator Drills are bone cutting and drilling instruments that are...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	An endometrial suction curette is a device used to remove material from the u...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	A circumcision clamp is an instrument used to compress the foreskin of the pe...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	A uterine tenaculum is a hook-like instrument used to seize and hold the cerv...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	Gardner-Wells traction tongs are skull tongs for traction used to immobilize ...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	McKenzie enlarging burrs are bone cutting and drilling instruments that are u...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Sep 8, 2014	D'errico perforator drills are bone cutting and drilling instruments that are...	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...	Class II	Instrumed International, Inc.
Aug 8, 2014	CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig...	CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven...	Class I	CareFusion 203, Inc.
Jul 31, 2014	CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira...	The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp...	Class II	Carefusion 2200 Inc
Jun 17, 2014	SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006...	CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a...	Class II	CareFusion 303, Inc.
Apr 23, 2014	Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits...	CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ...	Class I	CareFusion 303, Inc.
Mar 19, 2014	SmartSite Extension Set, Model No. 20029E, intravascular administration set.	Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.	Class II	CareFusion 303, Inc.
Jan 22, 2014	SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ...	CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec...	Class II	CareFusion 303, Inc.
Jan 16, 2014	Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, mod...	CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they m...	Class II	CareFusion 303, Inc.
Dec 5, 2013	Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto...	CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will...	Class I	CareFusion 303, Inc.
Nov 8, 2013	SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 243...	CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer becau...	Class II	CareFusion 303, Inc.
Nov 8, 2013	VersaSafe Extension Set, Model No. 21000M-007	CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may ...	Class II	CareFusion 303, Inc.
Sep 5, 2013	Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear...	CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ...	Class I	Carefusion 211 Inc dba Carefusion
Aug 30, 2013	CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us...	CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date....	Class II	CareFusion 303, Inc.
Aug 30, 2013	SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing...	CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 1301631...	Class II	CareFusion 303, Inc.
Aug 30, 2013	SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administr...	CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is...	Class II	CareFusion 303, Inc.
Aug 28, 2013	*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareF...	Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, p...	Class II	Carefusion 2200 Inc
Jun 17, 2013	Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo...	CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope...	Class I	CareFusion 303, Inc.
Apr 22, 2013	1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ...	CareFusion has received four (4) customer reports of a component (oxygen connector) within the re...	Class II	Carefusion 2200 Inc
Apr 12, 2013	Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.	On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care...	Class III	Covidien LLC
Apr 12, 2013	Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID...	On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care...	Class III	Covidien LLC
Mar 6, 2013	Alaris PC unit model 8015 with software version 9.12 Product Usage: The...	The recall was initiated because Carefusion has identified potential risk associated with bolus p...	Class II	Carefusion Corporation
Mar 6, 2013	Alaris PC unit model 8015 with software version 9.12 Product Usage: The A...	The recall was initiated because Carefusion has received reports of a communication error on the ...	Class I	Carefusion Corporation
Mar 4, 2013	Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product...	An internal review of CareFusion's labeling for preoperative skin prep product codes was recently...	Class III	CareFusion 213, LLC
Dec 20, 2012	CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blo...	CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separatio...	Class II	Carefusion 303 Inc
Jun 29, 2012	Alaris Pump Module model 8100. Subsequent product code: FPA The Pump mo...	The recall was initiated because Carefusion identified a potential risk associated with the Alari...	Class I	CareFusion 303, Inc.
Jun 19, 2012	CareFusion EnVe Ventilator Designed for use on patients who require respir...	CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Press...	Class I	CareFusion 203, Inc.
Jun 15, 2012	Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Pro...	The recall was initiated because Carefusion has identified a potential risk associated with the A...	Class I	CareFusion 303, Inc.
May 29, 2012	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ...	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ...	Class I	Carefusion 2200 Inc
May 29, 2012	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;...	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ...	Class I	Carefusion 2200 Inc
May 29, 2012	AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ...	The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ...	Class I	Carefusion 2200 Inc

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.