95,102 total recalls in our database
Abbott Laboratories
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Kits contain leaking bottles of isopropyl alcohol
Abbott Laboratories
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
NordicNeuroLab AS
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
MEDLINE INDUSTRIES, LP - SPT
Kits contain leaking bottles of isopropyl alcohol
Intuitive Surgical
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Fresenius Medical Care Holdings
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
The device may potentially cause a fire, leading to a safety risk.
Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
Stryker Instruments
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Device was marketed without FDA 510(k) clearance or a PMA.
Kits contain leaking bottles of isopropyl alcohol
MEDLINE INDUSTRIES, LP - SPT
Kits contain leaking bottles of isopropyl alcohol
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Intuitive Surgical
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.