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Showing 7541–7560 of 8393 results

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Heartware, Inc.: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product...

The pump has an impeller with a shroud height that did not meet the lower control limit.

FDAMay 28, 2021Nationwide• Heartware, Inc.

Southwest Technologies Inc: Stimulen Collagen Moisturizing Lotion, ST9555B

Dose audit failure after sterilization process

FDAMay 28, 2021Nationwide• Southwest Technologies Inc

Unknown Manufacturer: Palindrome Precision RT Chronic Catheter Kit Symmetrical ...

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

FDAMay 28, 2021Nationwide

Stryker GmbH Bohnackerweg 1 Selzach Switzerland: Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Ela...

The devices have a different inner diameter than the diameter specified on the outer box label.

FDAMay 27, 2021Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Siemens Medical Solutions USA, Inc: ARTIS pheno- angiography systems developed for single and...

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

FDAMay 27, 2021Nationwide• Siemens Medical Solutions USA, Inc

Owen Mumford USA, Inc.: Unifine Pentips Plus, hypodermic needle - Product Usage: ...

Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

FDAMay 26, 2021Nationwide• Owen Mumford USA, Inc.

Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium: Proteus 235-Proton Therapy System

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

FDAMay 26, 2021FL, PA, TN +2 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: Azurion systems with software release R1.x

In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

FDAMay 26, 2021Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Southmedic, Inc.: OxyMask O2 Adult REF OM-1125-14

Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.

FDAMay 25, 2021IL• Southmedic, Inc.

Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom: Tempus Pro - Patient physiological monitor, arrhythmia d...

The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

FDAMay 25, 2021Nationwide• Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

Canon Medical System, USA, INC.: Toshiba Vantage Tiitan 1.5T with Standard gradient, Premi...

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: us...

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Canon Medical System, USA, INC.: Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF...

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

GE Healthcare, LLC: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

FDAMay 21, 2021Nationwide• GE Healthcare, LLC

Canon Medical System, USA, INC.: Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, ...

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

FDAMay 21, 2021Nationwide• Canon Medical System, USA, INC.

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: ProxiDiagnost N90. radiography and fluoroscopy system

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Arrow International Inc: Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Pr...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

Arrow International Inc: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacin...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany: DigitalDiagnost 4 High Performance. radiography and fluo...

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

FDAMay 19, 2021Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany

Arrow International Inc: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr...

Marketed without a 510K

FDAMay 19, 2021Nationwide• Arrow International Inc

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