Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 3, 2024 | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse CV 6. with AR. A web-based application as the primary user interfa... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; ... | A software error caused an increase in tray gripper motion errors that causes intermittent hard s... | Class II | Beckman Coulter, Inc. |
| Jan 3, 2024 | Achieva XR. Model (REF) Numbers 781153, 781253. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... | The incorrect device is contained in the labeled package. | Class II | Tornier, Inc |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Jan 3, 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... | Class II | Quidel Corporation |
| Jan 3, 2024 | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier | Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... | Class II | Zimmer Surgical Inc |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230... | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun... | Class I | Datex-Ohmeda, Inc. |
| Dec 28, 2023 | Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL,... | The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after ... | Class II | MRP, LLC dba Aquabiliti |
| Dec 28, 2023 | Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit C... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm d... | Class II | NeuroLogica Corporation |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, R... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... | Class II | Maquet Medical Systems USA |
| Dec 28, 2023 | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For U... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit ... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... | Class I | Abiomed, Inc. |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible... | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Class II | TruAbutment Inc. |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | New warnings are being added to the Instructions for Use for all affected products to reduce the ... | Class II | Abiomed, Inc. |
| Dec 26, 2023 | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
| Dec 26, 2023 | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... | GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... | Class I | Wipro GE Healthcare Private Ltd. |
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.