Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 2,951–3,000 of 8,689

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  Philips North America

  Cardiac Workstation 5000; Model Number: 860439;

  Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  Medtronic Perfusion Systems

  Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

  Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  Diagnostica Stago, Inc.

  Product: STA Liatest D-Di; REF: 00515;

  A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  Noah Medical Corporation

  Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization

  Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  Philips North America

  Cardiac Workstation 7000; Model Number: 860441;

  Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 12, 2025

  UIH Technologies LLC

  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

  Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

  Class II

• Medical Device Recall · September 12, 2025

  Argon Medical Devices, Inc

  Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous place

  Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

  Class II

• Medical Device Recall · September 12, 2025

  GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

  Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

  GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Medline Industries, LP

  Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

  Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

  Class II

• Medical Device Recall · September 11, 2025

  Boston Scientific Corporation

  TENACIO Pump without InhibiZone; UPN: 72404420;

  The potential for devices to experience inflation and/or deflation performance issues or difficulties.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Boston Scientific Corporation

  CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6)

  The potential for devices to experience inflation and/or deflation performance issues or difficulties.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  CareFusion 303, Inc.

  BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve S

  Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

  Class I

• Medical Device Recall · September 11, 2025

  Boston Scientific Corporation

  CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

  The potential for devices to experience inflation and/or deflation performance issues or difficulties.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Boston Scientific Corporation

  CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6)

  The potential for devices to experience inflation and/or deflation performance issues or difficulties.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Boston Scientific Corporation

  LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

  The potential for devices to experience inflation and/or deflation performance issues or difficulties.

  Class II

• Medical Device Recall · September 11, 2025

  Olympus Corporation of the Americas

  BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

  Class I

• Medical Device Recall · September 11, 2025

  Ferno-Washington Inc

  FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

  The fastening post hardware could loosen allowing the fastening post to detach from the cot

  Class II