Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Mar 3, 2014 Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: ... Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... Class II Biocardia, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Feb 27, 2014 Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc.... Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to no... Class II Trivascular, Inc
Feb 27, 2014 D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by:... On a rare occasion the D-10 software might generate an extra result by duplicating the result for... Class II Bio-Rad Laboratories, Inc.
Feb 20, 2014 PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Cat... Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have part... Class II Biosense Webster, Inc.
Feb 19, 2014 FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 19, 2014 FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 18, 2014 Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro... Class III Lin-Zhi International Inc
Feb 14, 2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... Class II Horiba Instruments, Inc dba Horiba Medical
Feb 13, 2014 VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011... Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an... Class II Accumetrics Inc
Feb 12, 2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... Class II Biosense Webster, Inc.
Feb 7, 2014 HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis... In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform... Class II Leica Biosystems Imaging, Inc.
Feb 7, 2014 MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ... Tyvek packaging may be worn, causing loss of package integrity. Class II Biocardia, Inc.
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Contr... Class II Lin-Zhi International Inc
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Cont... Class II Lin-Zhi International Inc
Feb 5, 2014 Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... Class II Alere San Diego, Inc.
Feb 4, 2014 Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the d... Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits d... Class II Focus Diagnostics Inc
Jan 29, 2014 Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product... Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766... Class II Implantech Associates Inc
Jan 28, 2014 Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the Alter... Unapproved material used by vendor in subset of shorts causing them to stretch more than usual an... Class II AlterG, Incorporated
Jan 24, 2014 RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medic... Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6... Class II Clarity Medical Systems 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 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
Jan 20, 2014 ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX... HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running t... Class II Horiba Instruments, Inc dba Horiba Medical
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.
Jan 16, 2014 LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System... Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems b... Class II Zest Anchors LLC
Jan 13, 2014 Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyval... Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting asse... Class II Accuray Incorporated
Jan 13, 2014 InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V... Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an ina... Class II Philips Healthcare
Jan 10, 2014 T:slim Insulin Delivery System Insulin Infusion Pump Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for... Class I Tandem Diabetes Care Inc
Jan 10, 2014 Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics ... Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Dir... Class II Focus Diagnostics Inc
Jan 9, 2014 Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with th... Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Jan 6, 2014 Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey... Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, "Go G... Class II Infantino LLC
Jan 6, 2014 Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Steriliz... Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lum... Class II Boston Scientific Corporation
Jan 6, 2014 Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Numb... Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer Dental Inc
Dec 24, 2013 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCl... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron F... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating L... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Nee... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rot... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connect... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave",... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, 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.