JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...
Abiomed has issued an Urgent Medical Device Correction updating the instructions for its Impella RP with SmartAssist and also its Impella RP Flex with SmartAssist heart pumps. The US Food and Drug ...
Medical device recalls, whether voluntary or mandated, are crucial for ensuring patient safety. Here are three recent recalls reported to the FDA: Phillips recalls monitoring service application ...
When it comes to medical devices, recalls can include not only "removals ... a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they ...
Lee, a practicing lawyer, provided some reassuring data about the legalities of using medical devices under recall ... "no," then he will back off on the procedure, he said.
The food and drink industry faced several major recalls in 2024, driven by safety risks, such as lead-contaminated cinnamon ...
Over the past few years, companies in consumer goods industries have seen a concerning trend that presents a complex challenge: product recalls ... and medical devices. This absence of easily ...
The product was first recalled by the company in December of 2024 with a letter to customers titled "URGENT: MEDICAL DEVICE RECALL," but the FDA only recently issued its recall. The FDA said ...
In contrast, the food and drink industry under the U.S. Department of Agriculture's (USDA) purview recorded the second lowest annual total in the last decade in 2024, despite setting a six-year high ...
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...