Category
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.
Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.
Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls found in similar devices.
Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.
Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.
Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.
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 because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.
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.
Philips is recalling Vue PACS Diagnostic Viewer software versions 12.1.5 to 12.2.8.454 because a defect may cause incorrect ischemic map calculations, potentially leading to misdiagnosis.
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.
Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.
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.
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.
Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.
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.
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.
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.
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
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.
OrganOx Ltd is recalling 20 metra liver perfusion systems because battery movement caused a cell to short against the retention bracket.
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