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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.
Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.
Smiths Medical is recalling 156,400 CADD-Solis AC adapters due to damaged or broken input plugs that may expose metal contacts. The affected adapters could pose a risk of electrical shock or fire.
Hobbs Medical is recalling Posi-Stop Injection Needles (25 gauge) because some units contain debris in the needle shaft that blocks injection solution flow.
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris inside the needle shaft that blocks medication flow. The affected lot was distributed across multiple US states and Canada.
EnChroma Inc recalls 53 units of safety glasses with Rx indoor lenses that fail impact safety standards, posing a risk of eye injury. Affected models include Martinez Cx1 Indoor Rx, Summit Indoor Rx, and Martinez Black Cx Rx.
Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.
Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris that can block needle flow. Some units may contain debris in the inner sheath that prevents injection solutions from functioning properly.
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.
Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.
Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.
Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls found in similar devices.
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