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 The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a… GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery… Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportConnecticutthe one state its words name PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereConnecticut
- Medical device recall Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific, ENERGEN DR ICD Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable… Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportTennesseethe one state its words name PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a… There is a possibility of elevated temperatures in the seat pad. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina, South Dakota, Texas and Virginia named
- Medical device recall Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length Zimmer recently conducted a review of historic packaging validations completed. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, US Virgin Islands and Wisconsin named
- Medical device recall EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories Endogastric Solutions, Inc. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF… On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Product Name: nanoPOINT Injector System The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the… Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Edwards Lifesciences Suction Wand Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic MiniMed Paradigm Reservoirs Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps… Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PleuraGuide Disposable Chest Tube Kit Individual component’s IFUs are not included with the kit. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4” X 4 “,… Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and… GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ConvaTec Flexi-Seal SIGNAL Fecal Management System ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal… Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ConvaTec Flexi-Seal SIGNAL + ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal… Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Stryker Visum 300 Ceiling-mounted Exam Light. Potential incomplete final weld on the drop tube flange. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Getinge Assure Accufast Biological Indicators AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Blue Belt Technologies, Inc Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide, and California and Pennsylvania named
- Medical device recall GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate… Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical… Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 00597001101 Femur CR PRECOAT FEM 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 00597001131 Femur CR PRC SURF HDN FEM CO-NID 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 00597201101 Femur CR POROUS FEM 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 65597201131 Femur CR POR FEM SURF HDN HATCP 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 00597201131 Femur CR POR SURF HDN FEM CO-NID 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 65597201101 Femur CR POR FEM HATCP 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 00597601201 Femur CRA PRECOAT FEM COMP SIZE 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 00595601201 Femur CR-FLEX OPT FEM 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 00595001201 Femur CR-FLEX PCT FEM 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 00595201201 Femur CR-FLEX POR FEM 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 65595201201 Femur CR-FLEX POR HATCP FEM 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 00597001303 Femur CR PRC FEM COMP SIZE CML 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 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML 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 00597201303 Femur CR POR FM COMP SIZE CML 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 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, 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 65597201333 Femur CR POR FEM SURF HDN HATCP CML, 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 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, 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 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, 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 00595202010 Articular Surface XLPE CR ART SURF 1,2/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 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 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 00597002009 Articular Surface CR ART SURF 12/PURPLE 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 90597002009 Articular Surface CR ART SURF 12/PURPLE 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 00597202009 Articular Surface CR ART SURF 12/PURPLE 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 00597602010 Articular Surface AC ART SURF 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 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 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 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 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 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 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 90597003109 Articular Surface CR ART SURF 34/STR YEL 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
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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