Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Phadia 1000 Instrument, Article Number 12-3800-01. The “Retry” command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray… Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of… Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of… Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction… Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Mobile Mini C-arm system Part # 1000-0001 OrthoScan Inc. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall Mobile Mini C-arm system Part # 1000-0004 OrthoScan Inc. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall Mobile Mini C-arm system Part # 1000-0005 OrthoScan Inc. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall Mobile Mini C-arm system Part # 1000-0004-FD OrthoScan Inc. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medical device recall Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A… A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended… Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200… On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were… Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606,… On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were… Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sundream 12 V tanning bed The 30 minute maximum tanning time has been reduced to 20 minutes. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report33 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm… Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not… Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportKansasthe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereKansas
- Medical device recall UNIVERSAL FLEX2 BREATHING CIRCUIT Potential for leak test failures. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report43 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Alaris Syringe Pump The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alaris PCA Pump The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cordis S.M.A.R.T Potential for cracked luer hubs Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall EMPOWR Porous Knee System TIBIAL PUNCH, SMALL The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall EMPOWR Porous Knee System TIBIAL PUNCH, LARGE The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general… The tube adapter-plate green/yellow protective earthing (PE) wire was removed. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Healthcare Brilliance iCT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Healthcare Brilliance iCT SP computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Healthcare IQon Spectral CT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Lateral Troch Plate Full Crimp - 254mm Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Troch Plate Full Crimp - 254mm Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COMP 12MM HUM FRAC STEM MACRO Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COMP PRIMARY STEM 8MM MINI Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECHO POR FMRL NC 9X125 Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CER OPTION TYPE 1 TPR SLEVE -6 Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CER BIOLOXD OPTION HD 32MM Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OSS CEMENTED IM STEM 12X150 Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RED SEXP DSTL FEM 19CM RT ASSY Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RED SEXP DSTL FEM 19CM LT ASSY Possibility that the patient label inside the product box was incorrectly labeled. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA… Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereMinnesota, Nebraska and Texas
- Medical device recall CADD-Legacy 1 Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Access 2 Immunoassay System Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. Class IIIFDA’s classJan 10, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 10, 2018ClassClass IIIStatusTerminatedWhereGeorgia
- Medical device recall Access 2 Immunoassay System, Remanufactured Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. Class IIIFDA’s classJan 10, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 10, 2018ClassClass IIIStatusTerminatedWhereGeorgia
- Medical device recall UniCel DxC 600i SYNCHRON Access Clinical Systems Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. Class IIIFDA’s classJan 10, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 10, 2018ClassClass IIIStatusTerminatedWhereGeorgia
- Medical device recall Mobile Detector Holder - Stationary X-ray System (RF System) If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the… Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular… Device was distributed with the etching missing from the product. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereMichigan, Minnesota and North Dakota
- Medical device recall Medfusion, Syringe Infusion Pump, Software Version V1.1 Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump’s ability to accurately detect the diameter of the syringe barrel, resulting in… Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medfusion, Syringe Infusion Pump, Software Version 6 (V6) Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump’s ability to accurately detect the diameter of the syringe barrel, resulting in… Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SafetyGlide Needle, 22GA 1-1/2in Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNo state 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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