Toshiba Aquilion CT System TSX-301A
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
All Recalls
95,102 total recalls in our database
When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.
🏥 Medical Devices Class I - Dangerous
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Clinical Innovations
🏥 Medical Devices Class I - Dangerous
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Toshiba Aquilion CT System TSX-302A
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S
Toshiba Aquilion CT System TSX-101A
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Toshiba Aquilion CT System TSX-301B
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
🏥 Medical Devices Class I - Dangerous
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
🏥 Medical Devices Class I - Dangerous
Overheating and burning of the wire insulation inside the applicator.
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Arrow International
🏥 Medical Devices Class I - Dangerous
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
🏥 Medical Devices Class I - Dangerous
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Climbing Sticks
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Folding steps can bend or break during use, posing a fall hazard.
Adhesive removers
Krud Kutter Inc. of Cumming, Ga.
🏠 Consumer Products Class II - Moderate
The packaging is not child resistant as required by the Poison Prevention Packaging Act and the labeling on the product violates the Federal Hazardous Substances Act because it does not warn of the hazard presented. The adhesive remover contains petroleum distillates, which pose aspiration and poisoning hazards if swallowed.
Liquid Force Response Kiteboard control systems
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The chicken loop release system, which is used to depower the kite, can stick and fail to open, posing a risk of injury to the kiteboarder.
Climbing tree stands
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The cable assembly on the climbing tree stand can release, posing a fall hazard to the user.
Climbing tree stands
Global Manufacturing Company, of Windom, Minn.
🏠 Consumer Products Class II - Moderate
The cable assembly on the climbing tree stand can release, posing a fall hazard to the user.
Children's denim pants
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The zipper pull can detach, posing a choking hazard to young children.
Ear Force® XO FOUR Stealth gaming headset
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Mold spores were found on the headsets, posing a risk of respiratory or other infections in individuals with chronic health problems.