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17 stories matching this filter · ← front page

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  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 2d agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda recalls · 12d agoCRLNegative
73
fda recalls48
fda medwatch41
fda press28
911
Psychiatry & CNS727
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease362
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  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 12d agoCRLNeutral↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 17d agoCRLNegative↗ 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
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 18d agoCRLNegative↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 19d agoCRLNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 22d 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 recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 29d agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 29d agoCRLNegative↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 29d agoCRLNegative↗ source
  • Bolton Medical Issues Urgent Recall of Relay Pro Thoracic Stent Graft Over Unclasping Fault
    Bolton Medical announced an urgent Class I recall of its Relay Pro Thoracic Stent Graft System, specifically the non-bare stent configuration 32 mm and larger. The recall was triggered because the…
    fda medwatch · 1mo agoCRLNegative↗ source
  • 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 · 1mo 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 · 1mo agoCRLNegative↗ source
  • 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 · 1mo 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 · 1mo agoCRLNegative↗ source