Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
28,535 detailed records are currently available in this category.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
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.
A limited number of product pouches may not have been sealed during packaging.
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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.
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…
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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.
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…
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.
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.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Unique Device Identifier (UDI) is missing from outer kit box label.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
