Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare
Class I - Dangerous
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Ortho-Clinical Diagnostics
Class I - Dangerous
CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.