Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 35 recalls
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the s…
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves.…
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;…
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed position…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils.…
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic ag…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process.…
Convenience kits labeled as sterile have not gone through the sterilization process.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that…