🏥 Medical Devices Class I - Dangerous
Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
🏥 Medical Devices Class I - Dangerous
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
🏥 Medical Devices Class I - Dangerous
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
🏥 Medical Devices Class I - Dangerous
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
🏥 Medical Devices Class I - Dangerous
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Ferno-Washington
🏥 Medical Devices Class I - Dangerous
The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
Otto Bock Healthcare Product
🏥 Medical Devices Class I - Dangerous
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
🏥 Medical Devices Class I - Dangerous
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
Becton, Dickinson and Company, BD Biosciences
🏥 Medical Devices Class I - Dangerous
Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.
🏥 Medical Devices Class I - Dangerous
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Sunrise Medical (US)
🏥 Medical Devices Class I - Dangerous
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
🏥 Medical Devices Class I - Dangerous
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
🏥 Medical Devices Class I - Dangerous
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
Advanced Sterilization Products
🏥 Medical Devices Class I - Dangerous
Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.