Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,189–1,200 of 1,678 recalls
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
There is the potential for the length of the trocar shaft to be too long.
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause:…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitati…