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…
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…
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…
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…
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…
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
Date Issued: February 5, 2025 The U.S. Food and Drug Administration (FDA) is alerting patients who use diabetes devices and their caregivers of reports where users of continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices did not receive or did not hear alerts from their smartphones. A missed alert…
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
This recall involves removing 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: TRUAIRE-5 02 CONCENTRATOR Model: O2C5L Serial Numbers: All units within serial number range: JA2311000001-JA2312000740…