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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system Device may be missing a sled component. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BARD MYPICC Kit One of the cases of product might not have been sterilized. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportUtahthe one state its words name PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereUtah
- Medical device recall BCI Advisor Vital Signs Monitor Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature). Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Montana named
- Medical device recall da Vinci Xi EndoWrist Stapler 45 Reload Blue Intuitive Surgical, Inc. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall da Vinci Xi EndoWrist Stapler 45 Reload Green Intuitive Surgical, Inc. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VPS Rhythm ECG Accessory Pack with Johans Adapter Product pouch label may not easily identify the lot number, expiration date and associated symbols.. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall VPS Rhythm ECG Accessory Pack Product pouch label may not easily identify the lot number, expiration date and associated symbols.. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall VPS TipTracker Stylet Accessory Product pouch label may not easily identify the lot number, expiration date and associated symbols.. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Peripherally Inserted Midline Catheter Kit with Placement Wire Product pouch label may not easily identify the lot number, expiration date and associated symbols.. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Discovery IGS 730 Interventional Fluoroscopic X-ray Systems The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Iowa, Illinois, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Wisconsin and West Virginia
- Medical device recall Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Iowa, Illinois, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Wisconsin and West Virginia
- Medical device recall Discovery IGS 740 Interventional Fluoroscopic X-ray Systems The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Georgia, Iowa, Illinois, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Wisconsin and West Virginia
- Medical device recall Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is… The device may give a falsely elevated result that is non-reproducible. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is… The device may give a falsely elevated result that is non-reproducible. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette Incorrect hCG results Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Minnesota and Rhode Island
- Medical device recall Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance… The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S The manufacturer has discovered that potentially out-of-specification products may have left the factory. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Kentucky, North Carolina, Tennessee, Utah and Washington
- Medical device recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is… Final quality control testing was not completed before the devices were distributed.. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Indiana, Louisiana, Michigan, North Carolina and Tennessee named
- Medical device recall FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The… During long-term storage (i.e. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania, Texas and Virginia named
- Medical device recall Percepta CRT-P MRI SureScan Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percepta Quad CRT-P MRI SureScan Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percepta CRT-P MRI SureScan Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percepta Quad CRT-P MRI SureScan Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator… Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AperFix AM Femoral Implant Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass 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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