95,018 total recalls in our database
FUJIFILM Healthcare Americas
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Ortho-Clinical Diagnostics
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Aesculap
The sterile blister packaging may be damaged, and sterility may be compromised.
Waldemar Link GmbH & Co. KG (Mfg Site)
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Howmedica Osteonics
Potential packaging breaches of inner blister and outer sterile blister.
Ortho-Clinical Diagnostics
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Canon Medical System, USA
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
Aesculap
The sterile blister packaging may be damaged, and sterility may be compromised.
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
Ortho-Clinical Diagnostics
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Ortho-Clinical Diagnostics
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Ortho-Clinical Diagnostics
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Howmedica Osteonics
Potential packaging breaches of inner blister and outer sterile blister.
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
Synthes (USA) Products
Products not sterilized, sterility cannot be confirmed
Ortho-Clinical Diagnostics
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Medical devices distributed, prior to sterilization