Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
🏥 Medical Devices Class I - Dangerous
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
🏥 Medical Devices 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.
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Unique Device Identifier (UDI) is missing from outer kit box label.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices 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.
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Vygon MFG, Inc., dba/ Churchill Medical Systems
🏥 Medical Devices Class I - Dangerous
Incorrect priming volume is printed on the device package.
🏥 Medical Devices Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
🏥 Medical Devices Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.