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 4661–4680 of 39,430 recalls

Class IIOngoing

BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

Becton Dickinson & Co.

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

October 31, 2024 · DeviceView details →
Class IIOngoing

BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988

Becton Dickinson & Co.

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

October 31, 2024 · Device
View details →
Class IIOngoing

BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296

Becton Dickinson & Co.

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

October 31, 2024 · DeviceView details →
Class IIOngoing

BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570

Becton Dickinson & Co.

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

October 31, 2024 · DeviceView details →
Class IIOngoing

BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624

Becton Dickinson & Co.

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

October 31, 2024 · DeviceView details →
Class IIOngoing

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Wilson-Cook Medical Inc.

Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

October 31, 2024 · DeviceView details →
Class IIOngoing

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

INCIPIO DEVICES

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

October 30, 2024 · DeviceView details →
Class IIOngoing

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No

SEASPINE ORTHOPEDICS CORPORATION

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

October 29, 2024 · DeviceView details →
Class IIOngoing

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

MicroPort Orthopedics Inc.

Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

October 29, 2024 · DeviceView details →
Class IIOngoing

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Smith & Nephew Inc.

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

October 29, 2024 · DeviceView details →
Class IIOngoing

Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No

SEASPINE ORTHOPEDICS CORPORATION

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

October 29, 2024 · DeviceView details →
Class IIOngoing

AMS Artificial Urinary Sphincter Control Pump

Boston Scientific Corporation

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

October 28, 2024 · DeviceView details →
Class IIOngoing

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

Boston Scientific Corporation

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

October 28, 2024 · DeviceView details →
Class IIOngoing

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

Smiths Medical ASD, Inc.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

October 28, 2024 · DeviceView details →
Class IIOngoing

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Noah Medical

Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

October 28, 2024 · DeviceView details →
Class IIOngoing

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

October 28, 2024 · DeviceView details →
Class IIOngoing

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

Smiths Medical ASD, Inc.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

October 28, 2024 · DeviceView details →
Class IIOngoing

Discovery MR750w 3.0T, whole body magnetic resonance scanner

GE Medical Systems, LLC

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

October 28, 2024 · DeviceView details →
Class IIOngoing

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Smiths Medical ASD, Inc.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

October 28, 2024 · DeviceView details →
Class IIOngoing

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

October 28, 2024 · DeviceView details →
← PreviousPage 234 of 1,972Next →