Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 15 ml Normal Saline ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 550 ml Sterile¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 8, 2017 | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ... | Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecti... | Class I | Leonhard Lang Medizintechnik GmbH |
| Aug 7, 2017 | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Gu... | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a pot... | Class I | Spectranetics Corporation |
| Aug 2, 2017 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha... | Class I | OriGen Biomedical, Inc. |
| Jul 21, 2017 | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9... | A component in the Certitude Loader may have a molding overflow defect that could detach during ... | Class I | Edwards Lifesciences, LLC |
| Jul 17, 2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 12, 2017 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... | Affected units may have a defective component that is intended to protect the internal circuitry ... | Class I | Philips North America, LLC |
| Jun 16, 2017 | CS 300 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 100i Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 100 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 9, 2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascu... | Penumbra has identified an issue in these four lots involving a raw material component of the del... | Class I | Penumbra Inc. |
| Jun 2, 2017 | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Cur... | Inadequate seal due to lack of adhesive glue | Class I | Sterilmed Inc |
| May 23, 2017 | Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... | Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... | Class I | Magellan Diagnostics, Inc. |
| May 23, 2017 | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... | Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... | Class I | Magellan Diagnostics, Inc. |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer P... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Replacement kit for outer shell, Broselow Product U... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEE... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer,... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pr... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressu... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
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.