Complete FDA and NHTSA recall records dated in May 2025.
These records include useful source details for the selected month.
Mazda North American Operations is recalling certain 2024-2025 Mazda3 and CX30 vehicles. The Sophisticated Air Bag Sensor (SAS) units may set an error code and deactivate the air bags, due…
With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange…
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a…
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate…
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the…
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
