Date Issued: March 19, 2024 The U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the FDA is taking to address these issues.  In November 2023, the FDA informed consumers, health care…

Summary Company Announcement Date: March 20, 2024 FDA Publish Date: March 20, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems Company Name: InfuTronix, LLC Brand Name: Brand Name(s) Product Description: Product Description Nimbus Pump System…

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 and Codes:  AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, 2K8000  AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, without Mask, 2K8001 …

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 US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with…

Summary Company Announcement Date: March 19, 2024 FDA Publish Date: March 20, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil Company Name: Pyramid Wholesale Brand Name: Brand Name(s) Product Description: Product Description Dietary supplements for sexual enhancement Company Announcement FOR IMMEDIATE RELEASE – March 19, 2024, Los Angeles,…

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…

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…

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…

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,…

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:…