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 APLIO 300 TUS-A300 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 APLIO 500 TUS-A500 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 APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 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 Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor),… Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep… Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or… Incorrect product label. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Iowa, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, Oregon, Pennsylvania and Tennessee named
- Medical device recall 18 cm (7”) PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer.… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 168 cm (66”) Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 28 cm (11”) PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer.… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 28 cm (11”) PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer.… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall PROXIMALE - 28 cm The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve,… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve,… The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereArizona, Ohio, Texas and Washington
- Medical device recall Medica ISE Module Calibrant A Lot was not functioning properly and not exhibiting the correct physical properties. Class IIIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 19, 2017ClassClass IIIStatusOngoingWhereNationwide, and Arizona, California, Florida, Michigan, North Carolina, New York and South Carolina named
- Medical device recall Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Nicolet¿ Elite¿ 3 MHz OB Probe Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Nicolet¿ Elite¿ 5 MHz Vascular Probe Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement Report44 statesnamed in where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereAlaska, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Beckman Coulter Synchron AQUA CAL Level 1 The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Burn Relief¿ For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655… Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being… Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATAR Disposable 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 Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites… A field report indicated some units within this lot were missing the bottom pouch seal. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kentucky, Missouri, New Mexico, Oklahoma, Oregon, Pennsylvania and Texas
- Medical device recall Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing… May result in elevated platelet backgrounds during routine startup/background checks. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New York, Puerto Rico, South Carolina, Tennessee and Texas
- Medical device recall CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system… Software bug which allows parameters to be changed unintentionally during use. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 12, 2017ClassClass IIStatusCompletedWhereNationwide, and California, Illinois, Minnesota and Ohio named
- Medical device recall 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm Mis-pack. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Texas and Utah named
- Medical device recall 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm Mis-pack. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Texas and Utah named
- Medical device recall Nussloch GmbH ASP6025 Tissue Processor Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report36 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm One lot of product does not include a screw for attachment to the tibial base plate. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereArizona, California and North Carolina
- Medical device recall Logic Fit Tibial Tamp Head The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Reverse Starter Reamer Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Glenoid Reamer Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report33 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal… Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Colorado, Florida, Illinois, Michigan, Missouri, Mississippi, Montana, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2” 800/CA Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportIndianathe one state its words name PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall Alaris PC Unit BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus 235 and Proteus ONE proton therapy systems Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Louisiana, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300 Label on the affected devices incorrectly identifies the injection location as “above” the balloon when it should be below the balloon and “below” the balloon… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereMichigan and Missouri
- Medical device recall Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340 Label on the affected devices incorrectly identifies the injection location as “above” the balloon when it should be below the balloon and “below” the balloon… Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereMichigan and Missouri
- Medical device recall Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device… Software issue Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, New Jersey, Virginia and Washington
- Medical device recall Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Potential for electric shock in the case of a failure to install the grommets, supplied with the system. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL Product was improperly labeled leading to improper storage. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sensis Vibe Systems with Software Version VD10B Software error. Class IIFDA’s classJul 12, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 12, 2017ClassClass IIStatusTerminatedWhereIowa, Indiana and Michigan
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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