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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative… Marketing the devices outside 510(k) requirements Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Maryland, North Carolina, South Carolina, Texas and Wyoming named
- Medical device recall AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of… Marketing the devices outside 510(k) requirements Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Maryland, North Carolina, South Carolina, Texas and Wyoming named
- Medical device recall AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in… Marketing the devices outside 510(k) requirements Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Maryland, North Carolina, South Carolina, Texas and Wyoming named
- Medical device recall Single Analyte DAU Calibrator Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. Class IIIFDA’s classApr 2, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 2, 2014ClassClass IIIStatusTerminatedWhereCalifornia
- Medical device recall MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product… Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for… Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN:… Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming named
- Medical device recall Drill Template and the Saw Guide for the Ulna Osteotomy System The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Colorado, Connecticut, Illinois, Indiana, Massachusetts, Michigan, North Carolina, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall DICOM Export Format for Sum Dose with Velocity v3.0.0 An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New York, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin named
- Medical device recall Weck¿ Vista”, Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10mm Weck¿ Vista” Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10 mm Weck¿, Vista” Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10 mm Weck¿, Vista” Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Weck¿ Vista” Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Weck¿ Vista” Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 12mm Weck¿ Vista” Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10/12 mm Weck¿ Vista” Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10/12 mm Weck¿ Vista” Universal Cannula, Product Usage: An endoscope and accessories is a device used to… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10/12MM X 100MM Weck¿ Vista” UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a… Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10 Weck¿ Vista” Universal Balloon Open Access Port - Standard Length Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10 Weck¿ Vista” Universal Balloon Open Access Port - Long Length Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10 Weck¿ Vista” Universal Balloon Open Access Port Short Length Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10/12 Weck¿ Vista” Universal Balloon Open Access Port Standard Length Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5/10/12 Weck¿ Vista” Universal Balloon Open Access Port Long Length Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Suture, Non-absorbable, Synthetic, Polyamide, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sutures, Non-absorbable, Silk, Sterile The products are being recalled because they did not meet minimum needle attachment strength requirements. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ovation Prime Abdominal Stent Graft System Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall D-10” Hemoglobin Testing System On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular… Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Iowa, Illinois, Kentucky and Washington named
- Medical device recall Morph AccessPro Steerable Introducer Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Morph AccessPro Steerable Introducer Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter:… Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereIllinois, Louisiana, Massachusetts, Pennsylvania, Rhode Island and Virginia
- Medical device recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter:… Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereIllinois, Louisiana, Massachusetts, Pennsylvania, Rhode Island and Virginia
- Medical device recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter:… Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereIllinois, Louisiana, Massachusetts, Pennsylvania, Rhode Island and Virginia
- Medical device recall i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of… Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit… Class IIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartMate II LVAD Pump and Pock Controller Kit Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 2, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant… Customers are resetting the default values outside recommended factory settings. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Connecticut, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Kentucky, New Jersey, New York, Pennsylvania, Wisconsin and Wyoming
- Medical device recall Reusable Clip Applier The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Delaware, Florida, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Virginia and Washington named
- Medical device recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL Moldy smell in product Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Iowa, Illinois, North Carolina and Texas named
- Medical device recall FreeStyle Blood Glucose Monitors System Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall FreeStyle Flash Blood Glucose Monitors System Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Mar Cor Purification Millenium HX Portable Reverse Osmosis System High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen Alere San Diego, Inc. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 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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