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 PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The… Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereArizona, Colorado, Illinois, Oregon and Washington
- Medical device recall Pediatric, 10Fr, Intermittent Urinary Catheters Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Amerigel Hydrogel Wound Dressing Wound management Formulation deviation Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Post-op Surgical Kits Wound management Formulation deviation Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Daily Dressing Packets Wound management Formulation deviation Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Saturated Gauze Dressing Wound management Formulation deviation Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MAS CardioImmune XL Cardiac Marker Control MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32… Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of… Aesculap Inc. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportKansasthe one state its words name PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereKansas
- Medical device recall Aquapak Adaptor, 028 NEB, INTL, Product No. 403128 Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728 Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall INFINITI VISION SYSTEM ULTRASOUND FMS Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line. Class IIFDA’s classDec 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2 Mold on gel filled Gel-E and Squishon products FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction… Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 3, 2014ClassClass IStatusTerminatedWhereColorado, Michigan and Montana
- Medical device recall Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a… The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Gyrus ACMI Disposable Falope-Ring Band Applicator Kits All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Dimension HB1C Flex reagent cartridge Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150 Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088 Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trabecular Metal Tibial Impactor To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Trabecular Metal Tibial Impactor Replacement Pads To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8MM,POTTS SCISSORS Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,LARGE NEEDLE DRIVER Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,BLACK DIAMOND MICRO FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,LONG TIP FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,MICRO BIPOLAR FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,PROGRASP FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,MARYLAND BIPOLAR FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM MONOPOLAR CURVED SCISSORS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM RESANO FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM PERMANENT CAUTERY HOOK Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM PERMANENT CAUTERY SPATULA Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM FENESTRATED BIPOLAR FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, TENACULUM FORCEPS Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, CARDIAC PROBE GRASPER Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, LARGE HEM-O-LOK CLIP APPLIER Recalled by FDA on Dec 3, 2014 Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, ATRIAL RETRACTOR SHORT RIGHT Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, DUAL BLADE RETRACTOR Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, MEGA SUTURECUT ND Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, SMALL GRASPING RETRACTOR Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM,MEDIUM-LARGE CLIP APPLIER Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, CURVED BIPOLAR DISSECTOR Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall 8MM, TIP-UP FENESTRATED GRASPER Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, Nevada, New York, Oregon, Texas and Utah
- Medical device recall Remel TB Potassium Permanganate (.5% Aqueous) 40192 The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Iowa, Missouri, North Carolina, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and… Software issues Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Idaho, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania and Texas
- Medical device recall Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, District of Columbia, Florida, North Carolina, Pennsylvania and South Carolina named
- Medical device recall AlignRT- Intended for prescription use Potential failure of AlignRT to assert interlock. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, Texas and Utah
- Medical device recall Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box A reagent within the test may return false negative results. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Illinois, Maine, New Jersey, New York, Pennsylvania, Virginia and Vermont 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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