All Recalls

95,114 total recalls in our database

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Other Drugs Nationwide View Details →

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Prescription Drugs Nationwide View Details →

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Other Drugs Nationwide View Details →

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

Jul 28, 2021 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

Jun 18, 2021 Other Medical Devices Nationwide View Details →

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

Sep 8, 2021 Infusion Pumps Nationwide View Details →

Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.

Jul 29, 2021 Other Medical Devices Nationwide View Details →

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Jul 8, 2021 Other Medical Devices View Details →

The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.

Jun 10, 2021 Other Medical Devices Nationwide View Details →

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

Aug 27, 2021 Other Medical Devices Nationwide View Details →