Recalls
Insulin Pump Recall
Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life Medtronic is notifying users of MiniMed 600 and 700 series insulin pumps of an increased risk for reduced battery life and less time until...
FDA publishes running list of unsafe imported radiation-emitting products for consumers
The U.S. Food and Drug Administration (FDA) has significant concerns about potentially hazardous radiation-emitting electronic products that importers try to bring into the U.S.To help protect public health, the FDA publishes “Import Alerts” along with information...
Safely Charge Hearing Aids, Glucose Monitors, Insulin Pumps, and Other Medical Devices to Avoid Overheating
Medical devices with rechargeable batteries meet important medical needs, but if they are not charged properly, they can overheat, which may result in fires, or cause minor injuries or serious burns. These devices: use USB ports to recharge batteries, include hearing...
Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA issued a Warning Letter to Cue...
FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to encourage the public to follow established anti-choking protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve the...
Latest Update on FDA’s Evaluation of Plastic Syringes Made in China for Potential Device Failures
Today, the U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China and announcing expanded actions for Jiangsu Shenli Medical Production Co. Ltd. with an...
Recall of Certain Philips Respironics Sleep Therapy Machines
Federal District Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines A federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to...
Avanos Recalls Kits Containing Sterile Water Based Products under Recall by Nurse Assist
Avanos Medical, Inc., in direct response to the Nurse Assist recall due to sterility concerns of their 0.9% sodium chloride irrigation USP and sterile water for irrigation USP. Certain lots of MIC Gastric-Jejunal Feeding Tube -...
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose – FDA Safety Communication
On February 21, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood...
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients,...
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn patients and health care providers to carefully monitor their Philips...
Evaluating Plastic Syringes Made in China for Potential Device Failures
Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform consumers, health care providers, and health care facilities that the FDA is...