💊 Drugs Class I - Dangerous
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
💊 Drugs Class I - Dangerous
Subpotent
🏥 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.
🏥 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
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
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
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ion Beam Applications S.A.
🏥 Medical Devices Class I - Dangerous
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Atellica IM BR 27.29 (BR) Assay 250 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: 10995477
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
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Angiodynamics
🏥 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.
🏥 Medical Devices Class I - Dangerous
There is potential for nonsterility of product due to a possible defect in the pouch seal.
🏥 Medical Devices Class I - Dangerous
There is potential for nonsterility of product due to a possible defect in the pouch seal.
🏥 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.