💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
All Recalls
95,102 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
🏥 Medical Devices Class I - Dangerous
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.
🏥 Medical Devices Class I - Dangerous
An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Perkin Elmer Life Sciences
🏥 Medical Devices Class I - Dangerous
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Becton, Dickinson and Company, BD Biosciences
🏥 Medical Devices Class I - Dangerous
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
🏥 Medical Devices Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.
🏥 Medical Devices Class I - Dangerous
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
🏥 Medical Devices Class I - Dangerous
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation
🏥 Medical Devices Class I - Dangerous
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.
🏥 Medical Devices Class I - Dangerous
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm discovered Ring/Dot artifact due to X-ray measurement error.