Dialysis clinics using B. Braun's Dialog+ machines have been told to stop using, quarantine, and return three lots of the blood tubing that carries a patient's blood to and from the machine. The FDA posted an Early Alert on the bloodline…
A software glitch that locks clinicians out of scanning and an unstable cable connection have left patients without imaging at the moments they needed it most, prompting an FDA early alert and a warning letter from Philips. Four patients have…
Oct 19, 2020, 08:00 ET "The new Biofine peritoneal dialysis solutions line is part of our ongoing commitment to expand supply of peritoneal dialysis solutions and make home dialysis available to more patients with kidney failure," said Mark Costanzo, President of FMCNA's Renal…
BETHLEHEM, Pa. — A Pennsylvania-based company on Wednesday issued a voluntary recall of a common intravenous fluid used by medical facilities to replace lost water and body salts. The company announcement states that the 1,000-millileter solution, which was distributed to facilities…
Oct 21 (Reuters) – Saluda Medical said on Wednesday it is undertaking a voluntary recall of certain Evoke neurostimulation devices after identifying a manufacturing-related issue, sending shares of the US-based firm to a record low. • The recall relates to certain Evoke Closed…
The recall affects 199 units distributed nationwide to healthcare facilities, including Diagnostic Radiological Services, Groote Schuur Hospital, Netcare facilities, Life Wilgers Hospital, Life Peglerae Hospital, Capital Radiology, and other healthcare providers. Microcatheters issued at Groote Schuur, Life, Netcare and more recalled…
Updated Oct. 20, 2026, 9:13 a.m. | By Kubobonke Luthuli The company has identified a manufacturing defect, which it says could pose a serious risk to patients The recall affects 199 units of the company’s tiny medical tubes, Direxion and Direxion HI-FLO Torqueable Microcatheters, which navigate…
An issue with the delivery component of Edwards’ SAPIEN M3 TMVR system has been associated with one patient death and one serious injury as of 5 October. The US Food and Drug Administration (FDA) has conveyed a ‘potentially high-risk’ issue affecting certain…
The FDA classified the MiniMed Flex insulin pump recall as Class II on October 5, 2026. Medtronic had initiated the recall on August 20, 2026, after discovering gaps in manufacturing verification testing. According to the FDA's official recall record, some pumps were released with…
Oct 15 — The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences delivery systems used in transcatheter mitral valve replacement after one death and one serious injury. The FDA said Edwards Lifesciences had asked customers to…
Medical device recalls, FDA safety warnings, faulty implants and devices that harmed patients.
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