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 5, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall GE Cabinet X-ray systems GE discovered these cabinet x-ray systems’ potential failure to comply with the Cabinet X-ray System performance standards. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, North Carolina, New Hampshire, Oregon, Pennsylvania, South Carolina and Washington
- Medical device recall Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and… Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Missouri and Pennsylvania
- Medical device recall Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and… Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Missouri and Pennsylvania
- Medical device recall Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography,… Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Missouri and Pennsylvania
- Medical device recall Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull,… In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Varian On-Board Imager Advanced Imaging System Varian MedicalSystems’ X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are intended for cutting,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are intended for cutting,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are intended for cutting,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, MIXTER FORCEPS, P/N 0250080010 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, HOOK SCISSORS, P/N 0250080020 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, RING HANDLE, P/N 0250080236 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, SPRING HANDLE, P/N 0250080237 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, ALLIS FORCEPS, P/N 0250080240 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, BABCOCK FORCEPS, P/N 0250080241 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080047 Laparoscopic Manual Instruments are intended for cutting,… The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, PENNINGTON FORCEPS, P/N 0250080242 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, CLAW FORCEPS, P/N 0250080244 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245 The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity… Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2014ClassClass 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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