Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam… Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field… Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee System Patella Bushings Zimmer received a trend of complaints indicating corrosion of product. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Natural-Knee System Patella Bushings Zimmer received a trend of complaints indicating corrosion of product. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Natural-Knee System Patella Bushings Orthopedic surgical instrument Zimmer received a trend of complaints indicating corrosion of product. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Natural-Knee System Patella Bushings Orthopedic surgical instrument Zimmer received a trend of complaints indicating corrosion of product. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ARIATELE TELEMETRY TRANSMITTER The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor… Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall GALT VALVED TEARAWAY INTRODUCER SET GALT VTI The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iTRACK250A Canaloplasty Microcatheter Kit One lot may not have been properly sealed, resulting in a non-sterile device. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer The device labeling is stamped with 330cc and the device is actually 380cc device. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Maryland, Michigan, New Jersey, Nevada, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long… The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CloverSnare 4-Loop Vascular Retrieval Snare This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report37 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile Persona Distal Valgus Alignment guide collet locks are seizing in the ‘unlocked’ position. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 3, 2014ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E,… Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size… Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Hawaii, Illinois and Michigan named
- Medical device recall Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE &… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT… Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety… The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury… Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor The firm became aware of a potential problem that was initiated by a customer complaint. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and… A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Illinois, Mississippi, New York, Ohio, Pennsylvania, Virginia, Washington and West Virginia named
- Medical device recall Cordis EMPIRA NC RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Cordis EMPIRA RX PTCA Dilatation Catheter The balloon may exhibit resistance to the removal of the balloon cover. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereArizona, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, South Dakota, Tennessee, Virginia and Wisconsin
- Medical device recall Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19),… Class IIIFDA’s classSep 3, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 3, 2014ClassClass IIIStatusTerminatedWhereAlabama, California, Maryland, North Dakota, New Jersey, Oklahoma and Texas
- Medical device recall DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s… The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens… Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I,… Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TomoTherapy Treatment System Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall TomoTherapy Treatment System Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, North Carolina, New Mexico, New York, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Apex Arc Hip Stem, Size 2, HA Coated Staining on hip implant. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Massachusetts, New York, Oklahoma, Texas and Virginia
- Medical device recall Vanguard 360 Femoral Boss Reamer, Label The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
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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