Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 877–888 of 1,678 recalls
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus deliv…
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve.…
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.