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8 stories matching this filter · ← front page

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  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 1d agoCRLNegative↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 11d agoCRLNegative↗ source
73
fda recalls49
fda medwatch41
fda press28
Psychiatry & CNS727
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease364
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 16d agoRegulatoryNegative↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 17d agoCRLNegative↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 26d agoCRLNegative↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 1mo ago↗ source