FDA: Class I recall of Teleflex Iso-Gard Filter S
Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…
FDA issues Safety Communication on tracheostomy tube shortages
Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Medical Device Safety Communication on tracheostomy tube shortages. Included in the shortages are Bivona tracheostomy tubes manufactured by ICU Medical, which are more likely to affect pediatric patients. Also on the shortage list are JOH Tube Tracheostomy…
FDA: Five companies are having amoxicillin shortages
Editor's Note As of November 1, the Food and Drug Administration (FDA) listed 26 amoxicillin products on its current drug shortages site. The FDA says increased demand is the largest cause of the shortage. The FDA does not list resupply dates, but the American Society of Health-System Pharmacists (ASHP) estimates…
FDA: Class I recall of Jiangsu Well Biotech COVID-19 Ag Rapid Test
Editor's Note The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA. No…
FDA: Philips Respironics recalls certain BiPAP, CPAP masks
Editor's Note The Food and Drug Administration (FDA) on October 19 identified the recall by Philips Respironics of certain masks for BiPAP and CPAP machines as Class I, the most serious. The recall was initiated because magnetic headgear clips that hold the masks in place can cause injury or death…
FDA authorizes bivalent COVID-19 vaccines as boosters for younger groups
Editor's Note On October 12, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines, Bivalent, to authorize their use as a single booster dose in younger groups, Health Purchasing News October 12 reports. The Moderna vaccine is now authorized for…
HHS expands provider list authorized to administer monkeypox treatment
Editor's Note The US Department of Health and Human Services (HHS) on October 3 amended the Public Readiness and Emergency Preparedness Act declaration for smallpox medical countermeasures to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox, monkeypox, and other orthopoxviruses during the declared emergency, Healthcare…
FDA: Class I recall of LivaNova’s LifeSPARC System
Editor's Note The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious. The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a…
FDA: Class I recall of certain Philips Respironics BiPAP machines
Editor's Note The Food and Drug Administration (FDA) on September 23 identified the recall by Philips Respironics of certain models of its BiPAP machines as Class I, the most serious. The recall was initiated because certain machines may contain a plastic contaminated with a noncompatible material. If the plastic is…
FDA: Class I recall of Baxter Clearlink Basic Solution Set with Duovent
Editor's Note The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious. The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances…
Free Daily News
- Comfort, targeted nursing speed recovery in colorectal surgery patients
- Study: Preoperative behavioral health evaluations improve orthopedic recovery
- 2026 ICD-10 updates bring hundreds of new codes, new complexity
- Standardized pathways cut costs, hospital days in pediatric surgery without raising complication rates
- UC Davis secures $2M to study bone health in prostate cancer, prevent post-injury arthritis
- Artificial disc replacement proves safe, efficient, cost-saving in outpatient spine surgery
- Hospital-affiliated doctors drive highest costs by avoiding lower-cost sites
- Imposter syndrome widespread among surgical trainees, disproportionately affects women
- Global nursing workforce grows but inequities jeopardize health progress
- Largest US healthcare fraud case reveals billions in false Medicare, Medicaid claims and vast schemes nationwide