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 SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, SMART 3/16” PEDS PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SORIN GROUP, SMART PERFUSION PACK, SMART 1/4” PEDS PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM -… Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM -… Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM -… Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27… Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for… In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington and West Virginia named
- Medical device recall Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated… Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Tomcat Instrument A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by… Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Pennsylvania and Texas
- Medical device recall OptiLITE(TM) Products for Laser Surgery It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MULTIGENT Creatinine (Enzymatic) Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or… Complaint of the head holder connector locking up mechanically when tightened. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania
- Medical device recall Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius… Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall CS 100i Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CS 100 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CS 300 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Minnesota, New York and Texas
- Medical device recall PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used… PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the… Class IIIFDA’s classAug 2, 2017in FDA’s Enforcement ReportAlabamathe one state its words name PublishedAug 2, 2017ClassClass IIIStatusTerminatedWhereAlabama
- Medical device recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Converters(R) Tiburon(R) Arthroscopy Drape Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Smiths Medical CADD Blue-Striped IV Administration Set The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Atrium iCAST Balloon Expandable Covered Stent Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass… Identification of small pinholes in a single packaging configuration of sterile pouches. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or… Identification of small pinholes in a single packaging configuration of sterile pouches. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the… Identification of small pinholes in a single packaging configuration of sterile pouches. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure… Identification of small pinholes in a single packaging configuration of sterile pouches. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure… Identification of small pinholes in a single packaging configuration of sterile pouches. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Iowa, Kentucky, New Jersey, New York, Texas and Washington
- Medical device recall VITEK 2 Gram Negative test kits containing colistin (cs01n) The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall STOCKERT Heater-Cooler System 3T, 230 V Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STOCKERT Heater-Cooler System 3T, 240V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STOCKERT Heater-Cooler System 3T, 208V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STOCKERT Heater-Cooler System 3T, 127V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STOCKERT Heater-Cooler System 3T, 120V/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall INVUITY(R) PhotonBlade(TM) A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage… Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Standex International Bakers Pride Microwave Ovens It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks. Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 26, 2017ClassClass 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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