All Recalls

95,018 total recalls in our database

FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

BioFire Diagnostics

🏥 Medical Devices Class I - Dangerous

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

Jun 7, 2021 Diagnostic Equipment Nationwide View Details →

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

Luminex

🏥 Medical Devices Class I - Dangerous

Potential for a false-negative result.

Oct 30, 2020 Diagnostic Equipment Nationwide View Details →

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

Jun 30, 2021 Diagnostic Equipment View Details →

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

Boston Scientific

🏥 Medical Devices Class I - Dangerous

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

Jun 3, 2021 Implants & Prosthetics View Details →

Ozone 500® Girls' and Boys' Elevate 24-Inch Bicycles

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The rear shock spring on the bicycles can become stuck, creating a pinch point between the spring and the seat, posing a risk of injury, or causing the bicycles to stop unexpectedly, posing a fall hazard to the rider.

Jul 14, 2021 Sports & Recreation Nationwide View Details →

Disney Baby Winnie the Pooh Rattle Sets

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The feet on the Winnie the Pooh rattle can detach, posing a choking hazard to young children.

Jul 14, 2021 Children's Products Nationwide View Details →

Creekside Kids Five-Drawer Chests

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The recalled chests are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries to children. The chests do not comply with the performance requirements of the voluntary industry standard ASTM F2057-19.

Jul 8, 2021 Furniture Nationwide View Details →