October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor. Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice to inform users about the potential for elevated levels of…
Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Jaco Assistive Robotic Arm Models: …
Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication
Español 简体中文 (Simplified Chinese) Tagalog Date Issued: October 25, 2024 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter referred to simply as BioZorb Markers) by Hologic Inc. On October 25, 2024, Hologic announced a voluntary recall…
Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX 101/800/060CZ 3895097392583540256004106716423014942525004382002 BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX 101/800/070CZ 3895101392596039330884010050402279040348264037975413361241524404156971421780442382374249341430594443059474368641 BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX 101/800/075CZ 3895100392574839330864025599403482540379744073768411792741348274152439415697042382344249234434889843488994365892 BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX 101/800/080CZ 3895103390967039330444037971405262141382254156969422469542300784232686424546942474074270931429119043059334305934430593543059364305938 BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX 101/800/085CZ 39220273951221403482442563834348861 BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX 101/800/090CZ 3895099395122039684064039797419702542178034238236426164842732314306047431043943766124387369 BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX 101/800/100CZ 389511039512194000129423007643060584372161438660043907444413606 BLUSELECT 6.0, CUFFED, FEN, 10/BX 101/802/060CZ…
FDA’s Critical Role in Ensuring Safe and Effective Flu Vaccines
Image Español The flu (influenza) vaccine you get at your doctor’s office or pharmacy is the result of year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts. Sound complicated? It is. As new strains of flu viruses emerge, the U.S. Food and Drug Administration closely coordinates with sister agencies and works…
Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life
This recall does not involve removing all products. Users should contact Medtronic if they experience significant reduced battery life to determine if a new pump is needed. The FDA has identified this recall as the most serious type. Affected Product Product Names: MiniMed 630G, 670G, 770G, 780G Model: See full list of affected devices. Lot/Serial…
Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life
Summary Company Announcement Date: October 04, 2024 FDA Publish Date: October 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Defect Company Name: Medtronic plc Brand Name: Brand Name(s) Product Description: Product Description MiniMed™ 600 series or 700 series insulin pumps Company Announcement Customers are being notified…
Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
This recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. UPDATE – Friday,…
Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
Summary Company Announcement Date: October 10, 2024 FDA Publish Date: October 16, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Presence of glass particulates Company Name: STASKA Pharmaceuticals Inc. Brand Name: Brand Name(s) STASKA Pharmaceuticals Product Description: Product Description Ascorbic Acid Solution for Injection Company Announcement FOR IMMEDIATE…
UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
Español 简体中文 (Simplified Chinese) Tagalog Update: October 16, 2024 The FDA has classified Cue Health’s recall of their two COVID-19 tests as Class II. FDA has also revoked the Emergency Use Authorization (EUA) for Cue Health’s two COVID-19 tests. Additional information is provided in FDA Actions. Date Issued: May 13, 2024 The U.S. Food and Drug Administration…