🏥 Medical Devices Class I - Dangerous
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
All Recalls
95,025 total recalls in our database
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Cook Medical
🏥 Medical Devices Class I - Dangerous
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
🏥 Medical Devices Class I - Dangerous
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
🏥 Medical Devices Class I - Dangerous
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
🏥 Medical Devices Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
🏥 Medical Devices Class I - Dangerous
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Dirty Lens May Cause Invalid or False Positive Results
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
🏥 Medical Devices Class I - Dangerous
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
🏥 Medical Devices Class I - Dangerous
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Philips North America
🏥 Medical Devices Class I - Dangerous
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
🏥 Medical Devices Class I - Dangerous
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.