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 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed… Due to potential for an x-ray exposure technique change. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Plus Monitor System (Kit w/10 Count Vials) Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Glucose Test Strips Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Nova Max Plus Monitor System (Kit w/10 Count Vials International) Reports of false abnormally high glucose readings from test strips FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical… The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam, Hawaii and Puerto Rico named
- Medical device recall 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm… DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C-QUR Mesh (All Sizes, shapes) Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall C-QUR Edge Mesh (All sizes and shapes) Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall C-QUR V-Patch Mesh (All sizes and shapes) Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall C-QUR TacShield Mesh (All sizes and shapes) Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce… GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 3.2mm Drill Bit OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE… Screen save images are included in wrong exam due to duplicate UID creation. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for… GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Siemens AXIOM Artis zeego x-ray, angiographic system Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall IsoGel AIR 84, Support Surface Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR” surface upon turning the… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Illinois, Maine, Michigan, Ohio, Texas and Virginia named
- Medical device recall 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Colorimetric (CM)/ Rate (RT) incubator wear pads Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 21, 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, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below Veridex, LLC has received a report that a patient’s demographics were incorrectly associated with another patient’s identification (PID) number. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below Veridex, LLC has received a report that a patient’s demographics were incorrectly associated with another patient’s identification (PID) number. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems) Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 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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