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…
Jack and the Green Sprouts Recalls Expired Alfalfa Sprouts Because of Possible Health Risk
Summary Company Announcement Date: February 07, 2025 FDA Publish Date: February 08, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Jack and the Green Sprouts, Inc. Brand Name: Brand Name(s) Jack & the Green Sprouts Product Description: Product Description Alfalfa Sprouts…
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Bard Peripheral Vascular, a…
Turkana Food Inc. Recalls Aleppo Tahini Sesame Paste 1lb (16oz) Because of Possible Health Risk
Summary Company Announcement Date: February 06, 2025 FDA Publish Date: February 06, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Salmonella Company Name: Turkana Food Inc. Brand Name: Brand Name(s) Product Description: Product Description Tahini Sesame Paste Company Announcement Turkana Food Inc. Kenilworth, NJ is…
Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type, Class I. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Integrated Arterial Catheters found in Arterial Line Insertion kits, bundles, trays…