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 LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble,… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble,… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible… Product contains particulates (fibers) Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect. Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Georgia, Iowa, Missouri, Mississippi, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Texas and Virginia named
- Medical device recall Steinmann Pin A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kirschner-Wire (K-Wire) A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular… Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement Report19 statesnamed in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, North Carolina, Nevada, New York, Oregon, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5 Under certain circumstances, the Left eye image may be saved as the Right eye image. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or… These products are being recalled because they were distributed without adequate labeling and instructions for use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005… Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before… Zimmer is initiating a lot specific recall of the Trabecular Metal” Reverse Glenosphere Distractor due to the potential of the device not functioning properly… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement Report23 statesnamed in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes… The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, 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 and West Virginia named
- Medical device recall Synthes Trauma Nail System Recall was initiated due to the possibility that the outer pouch was compromised. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics. The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Missouri, Mississippi, North Carolina, New Hampshire, New York, Pennsylvania and Texas named
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS The trial stems were manufactured using the wrong design. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereTennessee
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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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