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.
27,577 detailed records are currently available in this category.
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations…
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended…
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Cut resistant surgical glove liners lack sterility assurance.
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning…
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
Implant kit mislabeled
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter…
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter…
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product…
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Risk of unintended motion while the AIRO system is in transport mode.
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to…
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.
