🏥 Medical Devices • 15,809 recalls
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
Argon Medical Devices
The stiffness of the soft end of the guidewire caused tissue perforation.
Argon Medical Devices
The stiffness of the soft end of the guidewire caused tissue perforation.
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
Howmedica Osteonics
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
Philips North America
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.
Baxter Healthcare
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Baxter Healthcare
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Merit Medical Systems
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Siemens Healthcare Diagnostics
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.
Avanos Medical
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
WELCH ALLYN, INC/MORTARA
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Philips North America
If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Baxter Healthcare
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Baxter Healthcare
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.