Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2021 | EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombo... | EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance | Class II | Ortho8, Inc. |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Num... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABE... | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece,... | Class II | PROCEPT BIOROBOTICS CORPORATION |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F ... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thromb... | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance | Class II | Ortho8, Inc. |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually opera... | The seating system unexpectedly detached, which resulted in the seating system falling to the gro... | Class II | Sunrise Medical (US) LLC |
| Jul 8, 2021 | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope ... | Class II | Carl Zeiss Meditec, Inc. |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually opera... | The seating system unexpectedly detached, which resulted in the seating system falling to the gro... | Class II | Sunrise Medical (US) LLC |
| Jul 5, 2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW releas... | An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event ... | Class II | Zeltiq Aesthetics, Inc |
| Jul 2, 2021 | The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser a... | Due to dispenser prompting for a missed dose that had already been dispensed | Class II | Hero Health |
| Jul 1, 2021 | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTIO... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jul 1, 2021 | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 ... | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect... | Class II | Beckman Coulter Inc. |
| Jun 18, 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 11, 2021 | CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D... | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 11, 2021 | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 11, 2021 | CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; | Due to reports of actuator separation for various delivery catheter systems. Affected products w... | Class II | Medtronic Heart Valves Division |
| Jun 9, 2021 | MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product ... | A portion of a validation lot was inadvertently released to the US Market. The product did not m... | Class II | CAREFUSION |
| Jun 7, 2021 | Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... | During product complaint investigation, it was determined that during stent graft deployment, the... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as ... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 7, 2021 | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G... | During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, a... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 3, 2021 | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... | Class II | Axonics Modulation Technologies, Inc. |
| Jun 1, 2021 | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross imm... | Due to insufficient column strength of the racks for all load conditions, racks associated with h... | Class II | Ossur Americas |
| May 27, 2021 | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, R... | Product distributed for use as an In-vitro Diagnostics without FDA clearance | Class II | Cell Marque Corporation |
| May 27, 2021 | Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, I... | Product distributed for use as an In-vitro Diagnostics without FDA clearance | Class II | Cell Marque Corporation |
| May 26, 2021 | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Mon... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure M... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx On... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Steril... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 26, 2021 | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure ... | There is a potential that the pressure tubing may detach from the blood sampling system | Class II | Edwards Lifesciences, LLC |
| May 21, 2021 | Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic im... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Prod... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI Sys... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 21, 2021 | Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product... | The MRI system contains a component that does not meet the appropriate flame retardancy-rating w... | Class II | Canon Medical System, USA, INC. |
| May 19, 2021 | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imagin... | The firm is aware of a issue with ultrasound software that results in unintended video frames b... | Class II | Caption Health |
| May 7, 2021 | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 4, 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product ... | Software anomalies affecting the French, German and Italian versions of treatment delivery system... | Class II | Viewray, Inc. |
| Apr 28, 2021 | Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... | Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... | Class II | Medtronic Vascular, Inc. |
| Apr 26, 2021 | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-L... | There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... | Class II | Alphatec Spine, 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.