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:…
Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap
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: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) Product Code: CBK Model Numbers:…
Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing
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: Cardinal Health Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35, and 60 mL) Cardinal Health Monoject sterile Enteral Syringes with…
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…
Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions
Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 3500 syringe pump Distribution Dates: August 9, 2002 to August 15, 2023 Devices Recalled in the U.S.: 85,961 Date Initiated by Firm: December 19, 2023 Device Use The Medfusion Model…
Follow Instructions for Safe Use of Electrical Operating Room Tables – Letter to Health Care Providers
February 29, 2024 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical operating room tables and is providing recommendations for health care providers to help protect patients. …
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…