🏥 Medical Devices Class I - Dangerous
There is potential for nonsterility of product due to a possible defect in the pouch seal.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Athena Medical Products
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Athena Medical Products
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Pipeline Flex Embolization Device
Micro Therapeutics Inc,
🏥 Medical Devices Class I - Dangerous
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.