Summary Company Announcement Date: February 13, 2025 FDA Publish Date: February 14, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared walnuts Company Name: JE Bakery LLC DBA Broadway Bakery Brand Name: Brand Name(s) Cub Foods, Jerrys Foods, Country Market Product Description: Product Description Raisin Bran Muffin Company Announcement JE Bakery…
ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
Summary Company Announcement Date: February 13, 2025 FDA Publish Date: February 14, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. Company Name: ICU Medical Brand Name: Brand Name(s) ICU Medical Product Description: Product Description POTASSIUM…
Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
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 StatStrip Glucose Hospital Meter System StatStrip…
AKT Trading Inc. Recalls Seasoned Bamboo Shoots Because of Possible Health Risk
Summary Company Announcement Date: February 11, 2025 FDA Publish Date: February 12, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Botulism Company Name: AKT Trading Inc. Brand Name: Brand Name(s) Product Description: Product Description Menma Ajitsuke Prepared Bamboo Shoot Company Announcement AKT Trading Inc of…
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
Date Issued: January 30, 2025 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers, health care facilities, patients, and caregivers that cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors (which are Contec CMS8000 patient monitors relabeled as MN-120) may put patients at risk after being connected…
Tri-Union Seafoods Issues Recall of Select Genova®, Van Camp’s®, H-E-B and Trader Joe’s® Tuna Cans Due to Clostridium Botulinum Risk
Summary Company Announcement Date: February 07, 2025 FDA Publish Date: February 10, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Botulism Company Name: Tri-Union Seafoods Brand Name: Brand Name(s) Genova, Van Camp’s, H-E-B, Trader Joe’s Product Description: Product Description Canned tuna Company Announcement EL SEGUNDO,…
Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
Summary Company Announcement Date: January 31, 2025 FDA Publish Date: January 31, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch Company Name: Alvogen, Inc. Brand Name: Brand Name(s) Product Description: Product Description Fentanyl…
Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow
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 Product Names/Models and Part Numbers: Phasitron Kit, VDR, Single Patient A50094-D, A50094-D-5PK Unique Device Identifier…
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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. The affected…
Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable
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: Life2000 Ventilator System Model/Unique Device…