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.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.
Seca is recalling 254 baby scale carts because wheels can loosen and detach, causing the cart to tip over and potentially injure a baby.
DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.
Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.
Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.
Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.
Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.
Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.
Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.
Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs because a software error causes the analyzer to incorrectly eject them as expired.
Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs due to a software error that causes the analyzer to incorrectly eject them as expired.
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