Summary Company Announcement Date: March 01, 2024 FDA Publish Date: March 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential interference with certain medical implants Company Name: Sleepnet Corporation Brand Name: Brand Name(s) Mojo, Mojo 2, iQ 2, Phantom 2 Product Description: Product Description CPAP and BIPAP Masks with Magnets Company…
Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
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 Device Use Avanos Medical MIC Gastric-Jejunal Feeding Tube and MIC Gastric-Jejunal Feeding Tube with ENFit Connectors are designed for patients who require simultaneous gastric decompression and jejunal…
Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop
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: HeartMate Touch Communication System Product Codes: See Recall Database Entry Distribution…
Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution
Summary Company Announcement Date: March 12, 2024 FDA Publish Date: March 12, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Silicone Particulate Matter Company Name: Endo International, Par Pharmaceutical Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Treprostinil 20mg/20mL Injection Company Announcement FOR IMMEDIATE RELEASE – March 12,…
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:…
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…