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 QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Packaging breach may compromise sterility Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for… Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio and Washington
- Medical device recall DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio and Washington
- Medical device recall DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio and Washington
- Medical device recall DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio and Washington
- Medical device recall DePuy Mitek LATARJET EXPERIENCE Extraction Driver Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio and Washington
- Medical device recall Merge OrthoPACS software. A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not… Class IIFDA’s classJun 28, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that… Elevating Monitor Suspension column dropping and will not rise back up. Class IIFDA’s classJun 28, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 28, 2017ClassClass IIStatusTerminatedWhereIndiana, Montana, Ohio and Pennsylvania
- Medical device recall Philips DigitalDiagnost 3.1.x X-Ray System During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Revolution EVO X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Optima CT660, CT680 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare LightSpeed VCT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Optima CT580 It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Optima CT520 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Optima CT540 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare lnnova IGS 540 ACT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare BrightSpeed X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Lightspeed RT16 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery Ml DR X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery IQ X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery Ml X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery NM/CT 670 CZT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Discovery NM/CT 570c X-ray system It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product… Tube arm assembly could fall down due to cracked welding joints Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Infant Warmer System (IWS) GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Video Bronchoscope This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Video Cytoscopes This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Video Naso pharyngo Laryngoscopes This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access… Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter… The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central… The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The… The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITEK¿ 2 Gram-Negative identification card (GN), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK 2 Gram-Positive identification card (GP), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK 2 Yeast identification card (YST), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK 2 Bacillus identification card (BCL), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK 2 Neisseria-Haemophilus identification card (NH), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia 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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