95,083 total recalls in our database
Merge Healthcare
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Invacare
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Invacare
The junction box used in the bariatric bed may emit sparks and result in a fire.
Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.
Stryker Leibinger GmbH & Co. KG
An incorrect sterility status on the label, non-sterile products labeled as sterile
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
Stryker Leibinger GmbH & Co. KG
An incorrect sterility status on the label, non-sterile products labeled as sterile
Boston Scientific
There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
The Empowr PS Insert was reported as missing the impaction slot feature.
Invacare
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
Ortho-Clinical Diagnostics
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.