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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.
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.
Happiest Baby, Inc is recalling 4 refurbished SNOO Smart Sleeper bassinets (Model S1000) that failed to meet quality standards before distribution. The recall is being reported retroactively.
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
Medical Action Industries is recalling cardiovascular procedure kits containing manifolds that may have particulate in the fluid path, which could enter blood circulation and lodge in blood vessels. FDA Class I.
ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.
Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.
IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.
Permobil Inc. is recalling 715 M5 Corpus Power Wheelchairs (REF 120032) because firmware versions 1.27 through 1.57 lack drive inhibit logic, which may allow driving under restricted conditions and cause instability.
Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, and organ dysfunction.
Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796060) because they may crack after cleaning and sterilization. The recall covers all lots and about 9,658 units distributed worldwide.
Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.
Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.
Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.
Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.
Medicom is recalling specific lots of Ritmed Neurological Sponges (Models 55992C to 55998C) because of potential unexpected variability in endotoxin levels.
Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.
Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm due to a potential risk of the rods cracking after cleaning and sterilization.
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