Class IOngoingZ-2979-2026
BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
BMC Medical Co., Ltd.Aug 26, 2026
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 634 recalls
Class IOngoingZ-2978-2026
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific Corp…MNAug 26, 2026
Class IOngoingZ-2977-2026
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System
Potential for arterial sheath tip separation or partial tip separation during use.
Boston Scientific Corp…MNAug 26, 2026
Class IOngoingZ-2872-2026
Bard Access Systems, Inc. recalls BD Needle Kit for Powered Driver 15mm x 15Ga
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove o…
Bard Access Systems, I…UTAug 26, 2026
Class IOngoingZ-2873-2026
Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter.…
Spectra Medical Device…MAAug 19, 2026
Class IOngoingZ-2766-2026
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Baxter Healthcare Corp…ILAug 19, 2026
Class IOngoingZ-2879-2026
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
Boston Scientific Neur…CAAug 12, 2026
Class IOngoingZ-2798-2026
AVID Medical, Inc. recalls Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
AVID Medical, Inc.VAAug 12, 2026
Class IOngoingZ-2797-2026
AVID Medical, Inc. recalls Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
AVID Medical, Inc.VAAug 12, 2026
Class IOngoingZ-2796-2026
AVID Medical, Inc. recalls Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds.…
AVID Medical, Inc.VAAug 12, 2026
Class IOngoingZ-2792-2026
Medical Action Industries, Inc. 306 recalls Pack Angiography NCMC 3/Cs BANNER
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within bl…
Medical Action Industr…NCAug 5, 2026
Class IOngoingZ-2735-2026
ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides cont…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
ResMed Ltd.Aug 5, 2026