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Showing 2441–2460 of 8389 results

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BIOTROL PURIT Cleaner (Young Dental) – Bacterial Contamination (2024)

The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.

FDAAug 23, 2024AZ, ID, MD +7 more• Young Dental Manufacturing I, LLC

Diode Laser Hair Removal WLA-01 (WINGDERM) – Labeling Issue (2024)

All model WLA-01 systems sold to US customers are found to have labeling non-compliances

FDAAug 23, 2024Nationwide• WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China

AVS Anchor-C Cervical Cage System (Stryker) – Labeling Correction (2024)

Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

Low

FDAAug 23, 2024Nationwide• Stryker Spine

Endoscopic Flushing Pump (Olympus) – Function Loss Risk (2024)

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

FDAAug 23, 2024Nationwide• Olympus Corporation of the Americas

MultiDiagnost Eleva (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper OR Table (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Healgen Urinalysis Strips (Healgen) – Sensitivity Reduction (2024)

The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.

FDAAug 22, 2024Nationwide• Healgen Scientific Llc

KINOVA Jaco Assistive Robot (Kinova) – Fire Hazard (2024)

Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.

FDAAug 22, 2024Nationwide• Kinova Inc

INTEGRIS Allura System (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion System (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

StealthStation S8 App (Medtronic) – Procedural Anomalies (2024)

Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.

FDAAug 22, 2024Nationwide• Medtronic Navigation, Inc.

Cortera Spinal Fixation Screw (XTANT) – Implant Marking Issue (2024)

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

FDAAug 21, 2024Nationwide• XTANT Medical Holdings, Inc

Change Healthcare Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

FDAAug 21, 2024Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Gastrointestinal Videoscope (Olympus) – Color Correction Problem (2024)

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

FDAAug 21, 2024Nationwide• Olympus Corporation of the Americas

McKesson Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

FDAAug 21, 2024Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Intrapulmonary Percussive Ventilator (Percussionaire) – Valve Labeling (2024)

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

FDAAug 21, 2024Nationwide• Percussionaire Corporation

Vanta Neurostimulator (Medtronic) – Battery Life Concern (2024)

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

FDAAug 21, 2024Nationwide• Medtronic Neuromodulation

Horizon Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

FDAAug 21, 2024Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Atellica IM aTPO Assay (Siemens) – Result Bias (2024)

Laceration Risk

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

da Vinci 5 Console (Intuitive) – Connector Error (2024)

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

FDAAug 21, 2024Nationwide• Intuitive Surgical, Inc.

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