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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.
Zimmer, Inc. is recalling NGK Stem Extenders because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer, Inc. is recalling 42,065 units of Distal Lateral Femoral Locking Plates because packaging testing revealed failures in sterile barrier integrity.
Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.
Zimmer, Inc. is recalling 42,065 femoral condylar buttress plates because packaging testing revealed failures in sterile barrier integrity.
Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.
Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.
Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.
Zimmer, Inc. is recalling 42,065 Tibia Nails because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.
Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.
Zimmer, Inc. is recalling 42,065 distal lateral femoral locking plates because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier integrity.
Zimmer is recalling specific CPT Hip System parts because they were packaged in the wrong outer cartons, though the product labels are correct.
Advanced Sterilization Products is recalling STERRAD Cyclesure Biological Indicators due to a microscopic flaw in the outer vial.
Steris is recalling Verify Dual Species Self-Contained Biological Indicators because the spore count is lower than labeled, potentially causing false sterilization results.
GE Healthcare is recalling 5 units of the Centricity Laboratory System because free-text data from instruments may be discarded if orders are not yet in the system.
Philips is recalling 93 HeartStart MRx Monitor/Defibrillators because the first therapy energy setting is mislabeled as 10 instead of 1-10.
Zimmer is recalling specific lots of medical devices because they were packaged in incorrect outer cartons, though the product labels are correct.
Steris Corporation is recalling SYSTEM 1E Liquid Chemical Sterilant Processing Systems because check valve o-rings degrade, causing nuisance aborts.
Zimmer is recalling specific lots of hip and shoulder devices due to incorrect outer packaging. Product labels are correct, but the outer cartons were wrong.
Synthes USA HQ, Inc. is recalling 290 Electric Pen Drive Hand Switches because the 'on' and 'lock' labels were interchanged.
Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter because some packages were shipped with incomplete installation and usage directions due to a printing error.
AdvanDx is recalling Gram-Negative QuickFISH BC kits because they are incompatible with certain fluorescence microscope light sources.
Merit Medical Systems is recalling 59 Maestro Microcatheters because the graphic on the carton's end panel does not match the front panel.
CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.
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