Complete FDA and NHTSA recall records dated in June 2024.
These records include useful source details for the selected month.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Complaints of unexpected detachment of the collimator have been reported.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako…
Complaints of unexpected detachment of the collimator have been reported.
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako…
Potential for pressure wave data synchronization from two devices may not be correct.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the…
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate.…
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako…
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the…
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
