Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 925–936 of 3,866 recalls
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Product not cleared by the FDA.
Product not cleared by the FDA.
Product not cleared by the FDA.
Reports of devices sparking/popping and potentially burning patients.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases no…
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases no…
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution.…