Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7726–7750 of 27393

HighFDA (Devices)·Z-2025-2023·2023-07-05
Philips Respironics V60 Ventilator recalled for potential gas pathway contamination
DRE Medical Group recalled 22 Philips Respironics V60 ventilators due to potential contamination in the gas pathway of retrofitted units. These devices may pose a serious health risk to patients.
Product
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2024-2023·2023-07-05
VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.
Product
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2049-2023·2023-07-05
LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects
The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2009-2023·2023-07-05
Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes
Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2007-2023·2023-07-05
NaviCare Patient Safety software versions recalled for alert suppression defect
Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.
Product
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2023·2023-07-05
Integre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission
Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.
Product
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2023·2023-07-05
Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error
Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.
Product
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2005-2023·2023-07-05
PushTracker E3 software failure may prevent stopping SmartDrive motor
A software defect in the PushTracker E3 watch can cause the SmartDrive motor to run uncontrollably, and users may not be able to stop the device using tap controls. Approximately 6,196 units worldwide are affected.
Product
PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2050-2023·2023-07-05
Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect
Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.
Product
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-2043-2023·2023-07-05
Access Hybritech p2PSA Reagent Recalled for Insufficient Blocking Reagent
Beckman Coulter is recalling Access Hybritech p2PSA diagnostic reagent kits with insufficient blocking reagent concentration. Three lot numbers affecting 987 kits were distributed in the US and internationally.
Product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2051-2023·2023-07-05
Exactech Ergo Impactor Handle Recalled for Component Dislodgement
Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.
Product
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-2047-2023·2023-07-05
Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2002-2023·2023-07-05
Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw
B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.
Product
Perifix¿ / Epidural anesthesia kit (10 count carton)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2004-2023·2023-07-05
PushTracker E2 watch app may crash, disabling wheelchair motor controls
Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.
Product
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2039-2023·2023-07-05
RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation
RaySearch America is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect dose calculations. The error could lead to inappropriate treatment plans being approved for patient use.
Product
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
Category
Medical Device
Distribution
4 states
CriticalFDA (Devices)·Z-1742-2023·2023-06-28
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Product
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1755-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.
Product
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1738-2023·2023-06-28
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy
Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.
Product
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1769-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.
Product
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1719-2023·2023-06-28
Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk
Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.
Product
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1725-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
Product
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1826-2023·2023-06-28
ARROW Endurance Peripheral Catheters Recalled for Separation and Leakage Risk
ARROW Endurance Extended Dwell Peripheral Catheters are being recalled due to potential catheter separation or leakage. The recall affects 262,016 units distributed nationwide and in Canada.
Product
ARROW Endurance Extended Dwell Peripheral Catheter System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1765-2023·2023-06-28
Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
Product
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1711-2023·2023-06-28
Medtronic Cardiac Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.
Product
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1704-2023·2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy due to defect
Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.
Product
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

7726–7750 of 27393