Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist

Please be aware, this recall is a correction, not a product removal.  The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Product Codes:…

Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock Connectors

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Medtronic Duet External Drainage and Monitoring System Catheter Tubing Product Codes: PCB Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite Injection…

Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error

Please be aware, this recall is a correction, not a product removal. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: ExactaMix Pro 1200, ExactaMix Pro 2400 Product Codes: LHI Model Numbers: ExactaMix Pro…

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Date Issued: February 29, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, manufactured by DT MedTech LLC. The FDA is evaluating interim post-approval study (PAS) results for the Hintermann Series…

Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

Summary Company Announcement Date: February 29, 2024 FDA Publish Date: February 29, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Limit use to patients aged 12 years or older. Company Name: Megadyne Medical Products, Inc. Brand Name: Brand Name(s) Product Description: Product Description Mega Soft Universal and Universal Plus Reusable Patient Return…

Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: EVair air compressors (model numbers M1230849, M1230847) EVair-03 air compressors (Jun-air; model numbers 1609000, 1609002) EvAir CPRSR Kits (model numbers M1230849, M1230847) Product Codes: See…