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.
23,306 detailed records are currently available in this category.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or…
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase…
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that…
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase…
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering…
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the…
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
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.
