Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Medtronic SynchroMed II Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are… Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic… The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereDelaware, Illinois, Minnesota, New York, Ohio and Pennsylvania
- Medical device recall Medtronic Sutureless Pump Connector Revision Kit The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Intrathecal Catheter Pump Segment Revision Kit The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic INDURA 1P Intrathecal Catheter The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Intrathecal Catheter The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall BD SafetyGlide Allergy There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prism Medical C-Series Carry Bar, Class I The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic SynchroMed II Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are… Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 3, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2013ClassClass IStatusTerminatedWhereNo state named
- Medical device recall CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips)… Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for… Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers… Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Centricity Laboratory System is intended to be an information system designed to support the clinical and… If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereGeorgia, Minnesota, New York, Ohio, Tennessee and Texas
- Medical device recall DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage:… The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereCalifornia and Illinois
- Medical device recall Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed… If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Delaware, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Mississippi, Montana, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Vermont, West Virginia and Wyoming named
- Medical device recall INFUSE(R) Bone Graft, SMALL KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft, MEDIUM KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft, LARGE KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft,LARGE II KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft, SMALL KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft, MEDIUM KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INFUSE(R) Bone Graft, LARGE II KIT Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies RF Technologies, Inc. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Georgia, Iowa, Kentucky, Montana, North Dakota, Nebraska, New Jersey and Wisconsin named
- Medical device recall Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may… Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Maine, New Mexico and Virginia named
- Medical device recall Brand Name: Infusor SV and LV Elastomeric Infusion Devices Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Multirate Infusor Devices Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Regional Analgesia Infusor System with Patient Control Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Intermate Infusion Pump Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Intermate Infusion Pump Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: SV Elastomeric Infusion Device Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Basal/Bolus Infusor Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic, Consulta¿ CRT-P Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems) Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h,… Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve Medical devices were incorrectly labeled with extended expiration dates. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Glidesheath (tm), 6 French, Nitinol wire Medical devices were incorrectly labeled with extended expiration dates. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYNCHRON System(s) Lactate (LACT) Reagent Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in… While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+… Class IIIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For… While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry… Class IIIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057,… Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057,… Installation Acceptance Test Document (IATD) non compliant with regulations. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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