This recall involves removing certain devices 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. Affected Product Spectrum V6 infusion pump startup screen Spectrum V8 infusion pump startup screen The FDA is…
Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
This recall involves removing certain devices 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. Affected Product The FDA is aware that BD and their subsidiary Bard Access Systems have issued a…
Newway Import Inc. Issues Allergy Alert on Undeclared Wheat in “Preserved Mustard in Soybean Oil” La Puente, Calif. – December 23, 2025
Summary Company Announcement Date: December 23, 2025 FDA Publish Date: January 05, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat Company Name: Newway Import Inc. Brand Name: Brand Name(s) Newway Import Product Description: Product Description Preserved mustard in soybean oil Company Announcement Newway Import Inc., located in La…
Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the…
Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
This recall involves removing certain devices 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. Affected Product The FDA is aware that Alcon has issued a letter to affected customers recommending certain…
Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets
This recall involves removing certain devices 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. Affected Product The FDA is aware that B. Braun Medical Inc. has issued a letter to affected…
Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
This recall involves updating instructions for using certain 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. Affected Product The…
Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
This recall involves removing certain devices 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. Affected Product Affected Item Numbers Product Description UDI Lot Number B33359 23″ (58 cm) 150 mL Burette…
Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
This recall involves updating instructions for using 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. Affected Product The FDA…
Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
This recall involves correcting devices and does not involve removing the devices 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 Name: Dexcom G6 Continuous Glucose…