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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are… During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660,… Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller… Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662,… Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller… Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proclaim DRG Implantable Pulse Generator Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller… Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VCLAS (Visualase Cooled Laser Ablation System) The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alaris Pump Module The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Panther(R) System An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportIndianathe one state its words name PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall Xpert EV Assay Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224,… New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210,… New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Assurity MRI New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Merlin PCS 3650 Programmer with New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Merlin@Home Software New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PM1214 NUANCE SR RF New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker… New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PM 1250 and PM 2250 ZENEX New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be… New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker… New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Pilling Knife Handles: a) The knife handles slot depth is out of specification, so blades may not fit on the handles properly. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2017ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The… Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. Class IIFDA’s classOct 25, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedOct 25, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, Massachusetts, Missouri, New York and Texas
- Medical device recall Fortify VR The device may exhibit premature battery depletion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify… The device may exhibit premature battery depletion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT c4000 Cuvette Segment, List number 02P75-01 There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000… Class IIFDA’s classOct 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PRISM MEDICAL A-625, MAX During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12,… Class IIFDA’s classOct 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Carina Mobile Lifts, Models: a) Carina350EM A limited amount of Carina mobile lifts have been delivered with a too small locking pin. Class IIFDA’s classOct 18, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 18, 2017ClassClass IIStatusTerminatedWhereMaryland, Ohio and Pennsylvania
- Medical device recall Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500 The device had an incorrect printed calibration value on the calibration certificate. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Ohio and Pennsylvania named
- Medical device recall Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S The high control for the kit is recovering low and may be out of range for assigned values. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500… There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, New Jersey, New York, Pennsylvania, Texas and Utah named
- Medical device recall AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+… Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BOMImed Disposable Fiber Optic Medium Laryngoscope Handle Potential for intermittent lighting (flickering) during use. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereIllinois, Pennsylvania and Washington
- Medical device recall IVEA Product The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after… Class IIFDA’s classOct 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. Class IIFDA’s classOct 11, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 11, 2017ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois and Massachusetts
- Medical device recall Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in,… Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Long Drill 1/4 inch Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32 Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch) Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Natural Nail System Calibrated Drill Long 4.3mm Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. Class IIFDA’s classOct 4, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 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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