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  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 4mo agoCRLNegative↗ source
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  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 4mo agoNeutral↗ source
  • Biopharma manufacturers turn to flexible, modular facilities to meet diverse therapy demands
    Biopharma development is increasingly focused on specialized and personalized treatments such as cell and gene therapies, antibody-drug conjugates and monoclonal antibodies. At the same time, the m…
    Fierce Biotech · 5mo agoPositive↗ source
  • Biotech layoff tracker 2026 shows Clinuvel cuts 20% staff, Novartis sheds 322 US jobs
    Fierce Biotech released its fifth annual layoff tracker for 2026, noting that workforce reductions continue to rise in the sector after a year of increasing cuts. The July update lists two compani…
    Fierce Biotech · 10mo agoLayoffsNegative↗ source
  • Biotech fundraising tracker reports $70M Series C for Ratio Therapeutics and $130M Series B for Crystalys Therapeutics
    The Fierce Biotech Fundraising Tracker continues to log only large venture capital rounds, focusing on deals of $50 million or more. Ratio Therapeutics secured a $70 million Series C, backed by in…
    Fierce Biotech · 10mo agoDealNeutral↗ source