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:…

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…

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…

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…

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…

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.  …

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…

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…

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…

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: Care Plus, Care Plus Models 1000 through 4000 and Lullaby Incubator, Lullaby Incubator…