Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3181–3200 of 39,430 recalls

Class IIOngoing

Intera Achieva 1.5T Pulsar; Product Number: 781171;

Philips North America

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

May 29, 2025 · DeviceView details →
Class IIOngoing

Intera 1.5T Master/Nova Product Number: 781106;

Philips North America

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

May 29, 2025 · Device
View details →
Class IIOngoing

Intera 1.5T Omni/Stellar; Product Number: 781104;

Philips North America

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

May 29, 2025 · DeviceView details →
Class IIOngoing

Achieva XR Product Numbers: (1) 781153, (2) 781253;

Philips North America

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

May 29, 2025 · DeviceView details →
Class IIOngoing

LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

MICROVENTION INC.

Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

May 29, 2025 · DeviceView details →
Class IIOngoing

Philips eL18-4 EMT Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Encore Medical, LP

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips C9-5EC Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Encore Medical, LP

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips eL18-4 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips C5-2 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips L12-3 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips X6-1 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips X8-2t Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

Terumo Cardiovascular Systems Corporation

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips V6-2 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips S5-1 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Encore Medical, LP

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips S7-2 Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
Class IIOngoing

Philips 3D9-3v Transducer.

Philips Ultrasound, Inc

Ultrasound transducer devices were refurbished beyond their useful life.

May 28, 2025 · DeviceView details →
← PreviousPage 160 of 1,972Next →