Complete FDA and NHTSA recall records dated in August 2023.
These records include useful source details for the selected month.
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.
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
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.
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…
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 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 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…
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…
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.
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.
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient,…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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.
