Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 24, 2025 | Welch Allyn CP150 Electrocardiograph: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Intera 1.5T R11, Model Number: 781170; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Intera 1.5T Power/Pulsar, Model Number: 781105; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 3.0T Quasar Dual, Model Number: 781150; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 0.5T Standard, Model Number: 781101; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Intera 1.5T Omni/Stellar, Model Number: 781104; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The nee... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Enterprise 1.5T, Model Number: 781145; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 24, 2025 | Intera 1.0T Omni/Stellar, Model Number: 781102; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The need... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | SmartPath to dStream for 1.5T, Model Number: 782146; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... | The associated product labeling does not adequately provide compatibility information for use of ... | Class II | Zimmer, Inc. |
| Mar 24, 2025 | Welch Allyn CONNEX Accessory Power Management Stand: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The ne... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | Intera 1.5T Explorer/Nova Dual, Model Number: 781108; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | SmartPath to dStream for 3.0T, Model Number: 782145; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 24, 2025 | Welch Allyn Connex Vital Signs Monitor (CVSM): | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Intera 1.5T Master/Nova, Model Number: 781106; | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 21, 2025 | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | OEC 3D | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Class II | GE Medical Systems, LLC |
| Mar 21, 2025 | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... | Class II | Radiometer Medical ApS |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may incre... | Class II | Phasor Health, LLC |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... | Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and... | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Class II | GE Medical Systems, LLC |
| Mar 20, 2025 | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... | Class II | Agilent Technologies, Inc. |
| Mar 20, 2025 | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the b... | Class II | Channel Medsystems, Inc. |
| Mar 20, 2025 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... | There have been at least 12 complaints from users as of March 3, 2025, reporting that they identi... | Class II | Maquet Cardiovascular, LLC |
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.