🏥 Medical Devices Class I - Dangerous
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
All Recalls
95,089 total recalls in our database
ReTurn 7500/7500 Aid, transfer
Handicare USA
🏥 Medical Devices Class I - Dangerous
During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.
🏥 Medical Devices Class I - Dangerous
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
🏥 Medical Devices Class I - Dangerous
A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Lumenis Limited
🏥 Medical Devices Class I - Dangerous
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
🏥 Medical Devices Class I - Dangerous
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.