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.
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…
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.
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…
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.…
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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.
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.
