💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,089 total recalls in our database
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
Pharmacy Plus, Inc.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Pharmacy Plus, Inc.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Pharmacy Plus, Inc.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Pharmacy Plus, Inc.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
🏥 Medical Devices Class I - Dangerous
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.
🏥 Medical Devices Class I - Dangerous
R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Spacelabs Healthcare
🏥 Medical Devices Class I - Dangerous
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
Syngo.plaza, Picture Archiving and Communication System
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Software upgrade to eliminate several issues
🏥 Medical Devices Class I - Dangerous
Product gives incorrect low blood glucose levels.
🏥 Medical Devices Class I - Dangerous
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
🏥 Medical Devices Class I - Dangerous
Product gives incorrect low blood glucose levels.
🏥 Medical Devices Class I - Dangerous
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
🏥 Medical Devices Class I - Dangerous
Software patch installation to address several safety issues.
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
🏥 Medical Devices Class I - Dangerous
Product gives incorrect low blood glucose levels.
🏥 Medical Devices Class I - Dangerous
Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
🏥 Medical Devices Class I - Dangerous
Administration Set potential filter leaking