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 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 Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin) Use of affected lots may give false indication of susceptibility to Nitrofurantoin. Class IIIFDA’s classSep 4, 2013in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 4, 2013ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, New York, Oklahoma, Pennsylvania, Rhode Island, Texas, Virginia and Washington
- Medical device recall 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the… Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts and New York named
- Medical device recall BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient… The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportArkansasthe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereArkansas
- Medical device recall Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics The power to the Esprit Display’s Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable. 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 HSV 2 Primers Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Delaware, Iowa, Minnesota and North Carolina named
- Medical device recall Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Maryland, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of… The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with “R” for right plate when they should be etched with… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Idaho, Indiana, Kentucky, Minnesota, North Carolina, New Jersey and Ohio named
- Medical device recall Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1… Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. 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 Mc Kesson Anesthesia-Rx The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Maryland, New Jersey, New York, Pennsylvania and West Virginia named
- Medical device recall Free Lock Femoral Hip Fixation System Compression Lag Screw Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several… Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different… Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT,… Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Indiana, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Ohio and Pennsylvania named
- Medical device recall OLA Buffer For Laboratory Use The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the correct mM unit. Class IIIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California named
- Medical device recall E-Z Clean¿ Disposable Laparoscopic Electrode Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Illinois, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania, Texas, Utah and Virginia
- Medical device recall GE Ultrasound ViewPoint 6 GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements… 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 Stryker 1) Asnis III Cannulated Screw Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Ohio, Texas and Virginia named
- Medical device recall 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4) 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Indiana, Missouri, New Jersey, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM… Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage)… The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Medtronic Custom Perfusion System Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Louisiana and Michigan named
- Medical device recall Medtronic Custom Perfusion System with Carmeda BioActive Surface Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Louisiana and Michigan named
- Medical device recall Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin) Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Louisiana and Michigan named
- Medical device recall SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M) SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Axiom Artis systems The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereDistrict of Columbia, Delaware, Maryland, New Jersey, Pennsylvania and Virginia
- Medical device recall ACCU-CHECK FastClix Lancing Device Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PrepStain AG PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service… 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 PrepStain Tecan US-I PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service… 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 PrepStain Tecan US-II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service… 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 DeRoyal Insufflation Tubing sets: 1) DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, 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, Washington, Wisconsin and West Virginia named
- Medical device recall ADVIA 120 Hematology Analyzer The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data… GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GE Healthcare, TRAM MODULE, High-acuity patient monitoring GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Benchmark XT/LT and Discovery XT Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument… Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare MobileDiagnostwDR system The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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