Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 325–336 of 371 recalls
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Device is missing the pin in the graft loader component.
Device is missing the pin in the graft loader component.
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System..…
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.