It was discovered that bottles of Brain and Memory Power Boost was filled with multi vitamin-mineral product - NeuroVite Plus
All Recalls
95,025 total recalls in our database
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
💊 Drugs Class I - Dangerous
Product Mix-up: Incorrect diluent component included in the kit.
💊 Drugs Class I - Dangerous
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
💊 Drugs Class I - Dangerous
Labeling: Incorrect Instructions
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
🏥 Medical Devices Class I - Dangerous
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
🏥 Medical Devices Class I - Dangerous
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
🏥 Medical Devices Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
🏥 Medical Devices Class I - Dangerous
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
🏥 Medical Devices Class I - Dangerous
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
🏥 Medical Devices Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.