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.
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message.…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message.…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message.…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to…
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of…
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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.
