Browse Device Recalls
3,435 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,435 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 3,435 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 11, 2019 | Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe Omn... | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Oct 3, 2019 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOV | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | Airway Gas Option N-CAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOVE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCAiOE | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCO | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 27, 2019 | CARESCAPE Respiratory Module E-sCOVX | Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... | Class I | GE Healthcare, LLC |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 16, 2019 | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Pr... | When using a specific tubing set with infusion pump system, may result in under deliver of fluids. | Class I | CME America, LLC |
| Sep 10, 2019 | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wo... | The instrument holder may be sent on a trajectory that is not within the intended target. If it i... | Class I | MEDTECH SAS |
| Aug 22, 2019 | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne... | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en... | Class I | LivaNova USA Inc |
| Aug 22, 2019 | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS M... | Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting ... | Class I | Thoratec Switzerland GMBH |
| Aug 9, 2019 | Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... | Class I | Medtronic Navigation, Inc. |
| Jul 30, 2019 | Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 ... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) ... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 m... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-104... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) ... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c)... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/ai... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 24, 2019 | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, St... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 24, 2019 | RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML... | The action was initiated following notification by the U.S. FDA of their recently updated, global... | Class I | Allergan PLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jul 9, 2019 | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... | The action has been initiated to address reports of burst balloons which have resulted in signifi... | Class I | Edwards Lifesciences, LLC |
| Jun 24, 2019 | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Prod... | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm pri... | Class I | Fenwal 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.