Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 7, 2024 | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | Plum 360/A+ spare batteries. Item Number: SUB0000864. | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... | Class II | Blue Belt Technologies, Inc |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 6, 2024 | American Contract Systems Gyn Laparoscopy convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Extremity convenience kit, American Contract System... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Cataract Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Special Procedure Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Biopsy Drape Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Hand Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Spine Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... | Class II | NovaSignal Corp. |
| May 6, 2024 | NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 | Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... | Class II | NovaSignal Corp. |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T TX for PET Model Number (REF): 781479 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Ingenia 1.5T S Model Number (REF): 781347 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee rep... | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP... | Class II | MicroPort Orthopedics Inc. |
| May 3, 2024 | ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
| May 3, 2024 | ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... | Class II | Atrium Medical Corporation |
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.