Complete FDA and NHTSA recall records dated in March 2021.
These records include useful source details for the selected month.
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard…
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may…
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not…
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications.…
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to…
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer…
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to…
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
The mirror may become detached and fall from the unit
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency…
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to…
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to…
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.
