MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits recall — FDA Z-2307-2023
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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.
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.
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.
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.
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…
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.…
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.
Browse recent months with enough recall history for useful comparison.