Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 337–348 of 2,088 recalls
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input.…
Due to manufacturing issues, reperfusion catheters may fractures
Due to device not having FDA Clearance
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospina…
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: af…
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail.…
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.