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.
Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.
NeuroLogica is recalling HS70A Diagnostic Ultrasound Systems due to a potential risk of probes overheating when users decrease the Doppler Sample Volume size in Doppler Only mode.
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x38 due to a manufacturing flaw in the sterile barrier system.
NeuroLogica is recalling WS80A Diagnostic Ultrasound Systems because probes may overheat when users decrease the Doppler Sample Volume size in Doppler Only mode.
Zimmer Biomet is recalling 30 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective.
Zimmer Biomet is recalling 19 units of Orthopedic Salvage System Hybrid Poly Tibia components because cleaning processes may be ineffective.
Santanello Surgical LLC is recalling 98 VAMPIRO V5001 suction sleeves because package integrity issues may compromise sterility.
Codman & Shurtleff Inc is recalling 28 units of the Galaxy G3 Mini Microcoil Delivery System because the label displays the incorrect coil length.
Zimmer Biomet is recalling 39 units of the Orthopedic Salvage System Hybrid Poly Tibia due to potentially ineffective cleaning processes.
Suntech Medical is recalling 80 neonate blood pressure cuffs because size #3 cuffs were packaged with size #4 labels.
Luminex is recalling ARIES HSV 1&2 Assay kits because side cassette seals did not meet specifications, potentially affecting test sensitivity and stability.
Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.
Zimmer Biomet is recalling 29 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The recall covers units distributed in the US, Japan, and the Netherlands.
Luminex Corporation is recalling Aries Bordetella Assay kits because partially sealed side cassette assemblies may reduce assay sensitivity or stability.
Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.
St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.
Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.
St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Intellijoint Surgical is recalling 23 G2 Workstations because the Apple MacBook Pro components may overheat and pose a fire safety risk.
Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.
St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
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