Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a Potential that product has not reached complete sterilization, Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Monaco Radiation Treatment Planning (RTP) System If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when… Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereTexas and Wisconsin
- Medical device recall Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Presence of natural rubber latex is not declared in the label Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Entuit Secure Gastrointestinal Suture Anchor Set There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas and Utah named
- Medical device recall Entuit Secure Gastrointestinal Suture Anchor Set There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas and Utah named
- Medical device recall Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent… The product is contaminated with Pseudomonas. Class IIFDA’s classMar 6, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 6, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, New Jersey, New York, Pennsylvania and Tennessee
- Medical device recall PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through… The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Randox CALCIUM (Ca) Colorimetric Method RX Series Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWherePuerto Rico and West Virginia
- Medical device recall daVinci Harmonic ACE Curved Shears During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Aplicare Povidone Iodine Prep Pads The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Aplicare Povidone Iodine Prep Pads The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Vitros Myoglobin Calibrators A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Pilling COOLEY SUMP-SUCTION TUBE The internal tip is missing from the device, causing the device to not function as intended. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereDistrict of Columbia, New York and Texas
- Medical device recall VITEK 2 AST-N351 Test Kit False Positive ESBL Phenotype Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Chemistry Products VALP Reagent Pack Negative bias results when using VITROS VALP Reagent, GEN 25. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate… Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate… Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Check-Flo Performer Introducer The products were manufactured with longer than specified sheaths. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Massachusetts, New York, Pennsylvania, Virginia and Wisconsin
- Medical device recall Stingray” Guidewire, labeled as 300cm A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05.… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including… Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular… Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereConnecticut, Florida, Illinois, Louisiana, Mississippi, Montana, Ohio, South Carolina and Texas
- Medical device recall Stationary Fluoroscopic X-ray System CombiDiagnost R90 kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Illinois, Minnesota, Missouri, Montana, New Jersey, Ohio, Texas, Utah and Virginia named
- Medical device recall Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker… A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):… A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR) A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall vitatron (implantable pulse generator): (a) A-series A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IStatusOngoingWhereNo state named
- Medical device recall MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage… There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 20, 2019ClassClass IIStatusOngoingWhereNationwide, and Alaska, 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Vergene Amplification Tray - 700uL, BC-GP On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. Class IIIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity TF PET/CT (non-RoHS) A software update is being issued to correct multiple issues identified in the previous software version. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Ohio and Pennsylvania named
- Medical device recall ATLAS Loading Car The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemotherm CE Dual Reservoir Cooler/Heater Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting… Some of the installed valve-inserts have a diameter smaller than the specification. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the… Some of the installed valve-inserts have a diameter smaller than the specification. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of… Some of the installed valve-inserts have a diameter smaller than the specification. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COBRA FUSION 50, Ablation System There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
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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