Loading...
Loading...
Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
The tibial tray lock detail is oversized (larger than specification).
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.