Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 3, 2019 | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... | Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... | Class II | Roche Diagnostics Corporation |
| Jun 1, 2019 | Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Hepari... | False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutaine... | Class II | Centurion Medical Products Corporation |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | CLEO Patient Monitor /Tranquility VS Patient Monitor | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did no... | Class II | Infinium Medical, Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear ... | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during t... | Class II | Baxter Healthcare Corporation |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:591... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear ... | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during t... | Class II | Baxter Healthcare Corporation |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 30, 2019 | Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ri... | Class II | Ortho Development Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 3... | Lot has been confirmed to have no additive within the tube. Sample processed without the preserva... | Class II | Becton Dickinson & Company |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxyge... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 30, 2019 | Clearview Total Uterine Manipulator (model UM750), The device is labeled in ... | An incorrect component used during manufacturing. The uterine manipulator tip support does not ha... | Class II | Clinical Innovations, LLC |
| May 30, 2019 | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 100... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 30, 2019 | Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... | Class II | Boston Scientific Neuromodulation Corporation |
| May 30, 2019 | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. | Class II | Medline Industries, Inc. |
| May 30, 2019 | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ri... | Class II | Ortho Development Corporation |
| May 30, 2019 | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | Surface micro/nano topography on some of the implants contained within this lot may not be consi... | Class II | Paltop Advanced Dental Solutions Ltd |
| May 29, 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... | Class II | AtriCure, Inc. |
| May 29, 2019 | Quantum Pump Console | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut d... | Class I | Spectrum Medical Ltd. |
| May 29, 2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedu... | Handle could jam with the Driver due to the detachment of an internal Connector Ring. | Class II | Pega Medical Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.