Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 21 recalls
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush.…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process.…
Kits contain a potentially contaminated component which were recalled by the manufacturer
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab…
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles;…