Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2019 | Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 15, 2019 | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende... | A defect involving an occluded needle was discovered during a training exercise. | Class I | Tytek Medical Inc |
| Nov 8, 2019 | CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ... | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... | Class I | Cook Inc. |
| Nov 8, 2019 | CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577... | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... | Class I | Cook Inc. |
| Nov 8, 2019 | CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583... | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... | Class I | Cook Inc. |
| Nov 8, 2019 | CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ... | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro... | Class I | Cook Inc. |
| Nov 5, 2019 | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visuali... | Exhibiting a reversed image. Although the image may appear normal, the users actions will be reve... | Class I | King Systems Corp. dba Ambu, Inc. |
| Oct 28, 2019 | Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei... | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ... | Class I | Smiths Medical ASD Inc. |
| Oct 24, 2019 | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 24, 2019 | Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 24, 2019 | Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69... | The firm has received reports of tip separation during usage of the catheters, which may expose ... | Class I | Applied Medical Resources Corp |
| Oct 11, 2019 | Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Oct 11, 2019 | Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 | There is a potential for the presence of a foreign particle inside the pump motor assembly which ... | Class I | Medtronic Neuromodulation |
| Oct 11, 2019 | Giraffe OmniBed infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| Oct 11, 2019 | Giraffe Incubator infant warmer | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... | Class I | GE Healthcare, LLC |
| 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. |
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.