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 SHOULDER PACK CODE 900-2766 CONTENTS Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ORTHOPEDIC PACK BASIC CODE 900-2830 Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CYSTO TUR PACK BASIC CODE 900-2899 Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall BASIC COSMETIC SURG Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ACDFPACK SURGICAL CENTER, CODE 900-2917 Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall TLIF PACK SURGICAL CENTER, CODE 900-2918 Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Obstetrical Surgical pack, code 900-2940, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Hair Restoration Pack- , code 900-2966, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Basic Pack FPSC Florham Pack , code 900-2969, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Chole Cystectomy All Endo System , code 900-3025, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Tummy Tuck Pack-BOD , code 900-3026, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Face Pack- BOD, code 900-3027, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Liposuction Pack BOD, code 900-3028, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Breast Pack BOD, code 900-3029, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110” X 77” LIF (I) COVER TABLE REINFORCED 50” X 90”… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall General Cosmetic Pack FCSC, Code 900-3113, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Tummy Tuck Pack- FJG, code 900-3114, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Liposuction Pack FJG, code 900-3115, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Face Pack FJG, code 900-3116, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Breast Pack- FJG, code 900-3118, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Laparoscopy pack, , Code 900-3178, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Breast pack TPSC, code 900-3431, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Open Heart Tray, Pack A, code 900-1196C, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall Lithotomy Pack III Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The… Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A… May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for… Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of… The attachment latch mechanism can become bent depending on user handling. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and… Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a… Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to… The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Idaho, Kansas, Kentucky, Maryland, Mississippi, New York, Ohio and Wyoming named
- Medical device recall Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C,… Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators 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 Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total… Product mix occurred prior to final package and labeling process. 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 LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter. Class IIIFDA’s classSep 10, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedSep 10, 2014ClassClass IIIStatusTerminatedWhereTexas
- Medical device recall V5Ms Transesophageal transducers Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ellipse Implantable Cardioverter Defibrillators (ICDs) An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STREAMLINE CT CERVICO-THORACIC SYSTEM Some set screw thread profiles were found not to be within specifications. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Michigan, North Carolina, New Hampshire and New York
- Medical device recall FOCAL Sim Workstation, Radiation Treatment Planning System When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan… Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Virginia and Washington named
- Medical device recall PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the… Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming named
- Medical device recall PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional… Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming named
- Medical device recall PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size… Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming named
- Medical device recall PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0… Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming named
- Medical device recall PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming named
- Medical device recall PERSONA” The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 10, 2014ClassClass 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, 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, West Virginia and Wyoming 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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