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 5, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall VersaSafe Extension Set CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System Reports of friction within certain instrument arms can interrupt smooth instrument motion. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam… A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Pennsylvania, Tennessee, Utah and Wisconsin named
- Medical device recall SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option… A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, North Carolina, New York, Pennsylvania, Tennessee, Utah and Wisconsin named
- Medical device recall C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy… This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use… During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereAlaska, Colorado, Florida, Massachusetts, Michigan and North Carolina
- Medical device recall GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNevadathe one state its words name PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNevada
- Medical device recall SmartSite Low Sorbing Infusion Set with Texium Close Male Luer CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Ohio, Utah and Wyoming
- Medical device recall Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin… Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the… Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Montana, New Mexico, New York, Texas, Utah and Virginia named
- Medical device recall Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller) There is a remote possibility for the plastic latch to deform over the lifetime of use. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The GE Centricity Web GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Illinois, Louisiana, Missouri, New Jersey, New York, Oklahoma, Tennessee, Washington and Wisconsin
- Medical device recall Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel… A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona named
- Medical device recall Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified… When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software… A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10,… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of… Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent… Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile”GLU Test Cassette Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed… Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies,… Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Montana, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and West Virginia named
- Medical device recall REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device,… Security Blades were manufactured oversized and potentially won’t advance or may be difficult to advance through the mating Security Clip. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tri-Nex Healing Abutment, 0.50 mm x 5 mm height Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed) Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot:… Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to… Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK… There is a software synchronization issue with the ACCU-CHEK Combo system. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Analyte Urine DAU Control Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in… Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereCalifornia
- Medical device recall Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For… The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Georgia, Illinois, Indiana, Michigan, Mississippi, New York, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation… All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is… Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension,… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in… All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal… A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Ohio and Utah named
- Medical device recall Baxter, VIAL-MATE Adaptor, 2B8071 Incomplete foil seal on one lot of sterile product. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Ohio, Tennessee, Wisconsin and West Virginia named
- Medical device recall Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover,… One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Missouri, Texas and Washington named
- Medical device recall Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or… During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall CSF-Unitized Shunt, Contoured Regular, Low Pressure Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0 Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Strata II Shunt Assembly Kit, Small Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short (“Driver”) Lanx, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, New York, Pennsylvania, Puerto Rico, Tennessee, Texas and Wisconsin named
- Medical device recall Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar… A plate was inadvertently released to a sales consultant that was restricted for sale. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportColoradothe one state its words name PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereColorado
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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