Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for… Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereArkansas, Iowa, Illinois, Kansas, Michigan, Minnesota, New York, Ohio, Wisconsin and West Virginia
- Medical device recall Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute… Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJul 26, 2017ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Indiana, Massachusetts, Michigan, Minnesota, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall Draeger Medical Systems Infinity Acute Care System (M540) Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereArizona, New Hampshire, South Dakota, Tennessee and Texas
- Medical device recall Agfa Healthcare NX 3.0.8950 Imaging Processing Software A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams,… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAKO RIO Standard System, internal cPCI Card CageP/N: 201337 An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to… Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display,… Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and… Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display,… Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Install CD, Spine tools, Plus and S7, Version 25 Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 5ml Syringe Luer-Lok” Tip with Blunt Fill Needle 18G x 1 1/2 BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD SafetyGlide” Injection Needle BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 3ml Syringe Luer-Lok” Tip with BD PrecisionGlide” Needle 23G x 1 BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 3ml Syringe Luer-Lok” Tip with BD PrecisionGlide” Needle 18G x 1 1/2 BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 3ml Syringe Luer-Lok” Tip BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 10mL Syringe Luer-Lok Tip BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD 3ml Syringer Luer-Lok Tip BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management,… When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study… Class IIFDA’s classJul 26, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Illinois, Michigan, North Dakota, New York and Ohio
- Medical device recall VIDAS Testosterone Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Georgia, Iowa, Illinois, Michigan, Minnesota, Montana, New York, Oklahoma, Tennessee, Texas and Wyoming
- Medical device recall ATAR Reusable Extension Cable The Reusable Oscor ATAR extension cables could separate from the connector during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement Report39 statesnamed in where it went PublishedJul 19, 2017ClassClass IStatusTerminatedWhereAlaska, Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple… A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proclaim 5 Elite, implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proclaim 7 Elite, Implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity 5, Implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity 5, Implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity 7, Implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity 7, Implantable Pulse Generator The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures… If the gantry module is replaced after original installation the configuration settings may be missing. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNew York and Pennsylvania
- Medical device recall Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology Arrow is recalling additional lots that were identified as part of an active recall. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Indiana, Massachusetts, New Jersey, Pennsylvania, South Carolina, Virginia and Washington
- Medical device recall Arrow Glide Thru Peel-Away Sheath/Dilator Introducer Arrow is recalling additional lots that were identified as part of an active recall. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Indiana, Massachusetts, New Jersey, Pennsylvania, South Carolina, Virginia and Washington
- Medical device recall Alaris Pump Module There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level… Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report35 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Exactech Optetrak Logic CC 15mm Tibial Augment Screws Missing Screw in carton. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medical device recall O-Two Adult Ventilation Timer Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultrasonic Endoscope Fujifilm is recalling multiple endoscopes after a retrospective review. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Hawaii and Missouri
- Medical device recall The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo… If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XARIO 100 TUS-X100 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XARIO 200 TUS-X200 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass 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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