Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is… Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is… Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CSI Stealth 360-degree Orbital Atherectomy Device (OAD) CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, Minnesota, Pennsylvania and Texas named
- Medical device recall GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2… GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, New Jersey, New York, South Carolina and Texas named
- Medical device recall Stryker brand Arthroscope and Hardware Set Tray (sterilization tray) The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the “Instructions for Use”; due to the firm’s evaluation… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 System 1 Base, 100/120V Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the… Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report41 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report41 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Edwards Lifesciences Rigid Suction Wand, sterile Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Maryland, Missouri and Texas named
- Medical device recall System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall System 1 Base 220/240V Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enFlow IV Fluid Warmer The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-Stat Portable Clinical Analyzer Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fuso Analyzer 300F Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-STAT1 Abaxis Analyzer Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-STAT1 Abaxis Analyzer Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Military Kit Portable Clinical Analyzer Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is… HOTLINE 3 Blood and Fluid Warmer( Reorder No. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pathfinder NXT Fixed Percutaneous Rod Holder Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pathfinder NXT Fixed Percutaneous Rod Holder Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics, Definition PM Femoral Hip Stem Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Eon Mini Neurostimulation (IPG) System (Model 3788) The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pudenz Flushing Valve with Integral Connectors The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System Please be aware that this is not a new recall. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for… Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereFlorida, Indiana, Massachusetts, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality… The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Oregon, Pennsylvania and Texas named
- Medical device recall Intellispace Portal software Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Indiana, Michigan, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling… GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, New York, Oregon and Virginia
- Medical device recall Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable… The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Georgia, Indiana, Kentucky, Louisiana, Montana, Texas, Utah and Wisconsin named
- Medical device recall Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device,… The Tyvek pouch label for this device states: ‘with holster’; however, this product does not come with a holster. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Georgia, Indiana, Kentucky, Louisiana, Montana, Texas, Utah and Wisconsin named
- Medical device recall Bayonet Forceps 7.75” Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75” are misbranded in that the manufacturer symbol was replaced by the expiry symbol on… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Bayonet Forceps 8.5” Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is:… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Bayonet Forceps 7.-1/8 Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Bayonet Forceps 8.25 Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter ‘E’ in Electrosurgical was turned into an ‘X’… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Bayonet Forceps 7.-1/8 Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter ‘E’ in Electrosurgical was turned into an ‘X’… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Irrigating Bayonet Forceps 8.25” Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter ‘E’ in Electrosurgical was turned into an ‘X’… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Maryland, Michigan, North Carolina, Oregon, South Carolina and Texas named
- Medical device recall Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications… In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode “edit contour” tool, the measurements are not… Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Louisiana, Michigan, North Carolina, New York, Ohio, Oklahoma and Pennsylvania named
- Medical device recall superDimension Systems AAS00016-xx with Software Version 4.0-4.9 superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Focal SIM Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall Monaco Product Usage: Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Washington and Wisconsin named
- Medical device recall AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 11, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 11, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 11, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico 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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