Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 30mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 40mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 50mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 60mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 70mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 80mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 90mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 100mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 110mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 120mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 400mm Straight Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4” There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Massachusetts, Michigan, Mississippi, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8”, Vol. 0.6 mL, Male Luer Lock Adapter,… Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7”, Vol. 0.8 mL, 2 Injection Sites, Male… Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7”, Vol. 1.10… Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0”, Vol. 1.0 mL, 2 Luer Activated… Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare Diagnostics Inc Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall ExoShape Soft Tissue Fastener 12 mm x 30 mm Expiration date on the patient label and date on the product carton were not the same. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Iowa, Maryland, Missouri, Oregon, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall Olympus SurgMaster UES-40 electrosurgical unit (“UES-40”) Product Usage: Designed for use in a medical… Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall DePuy Mitek Tissue Liberator -Blade Up Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereKentucky and New Jersey
- Medical device recall CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these… There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these… There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all… There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all… There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion… Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy’s parameters and causes an 11/004 error resulting in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion… Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy’s parameters and causes an 11/004 error resulting in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… Pump shutting off during use without warning. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… Pump shutting off during use without warning. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement Report39 statesnamed in where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180) When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is… Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX,… Vital Images, Inc. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medical device recall Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT… Software update to fix multiple safety related issues. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diacap(R) Ultra Dialysis Fluid Filter There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SL3 SOFT-TISSUE Laser (Model LR2002) The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia and Washington named
- Medical device recall Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous,… Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall HeartStart MRx Monitor/Defribillator Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339 There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile Owens & Minor Distribution, Inc. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt,… GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD… GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia 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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