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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.
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which reduces the standard curve slope.
Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.
Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.
Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.
Siemens Medical Solutions USA is recalling 21 Mobilette Mira mobile x-ray systems due to a risk of lost images during examination.
Stryker Howmedica Osteonics is recalling 8 Tibial Offset Bushings because rotational reference numbers were marked incorrectly or missing.
First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps because they may deliver medication at a higher flow rate than specified, risking over-administration.
Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.
Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.
Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.
Medtronic is recalling 12 Vertex Max Drill Tubes due to a defect in the internal threading used for component setup.
Parks Medical Electronics is recalling 349 vascular blood flow machines after two incidents where an air supply tube was connected to a patient's IV instead of a blood pressure cuff.
Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.
Zimmer is recalling specific lots of NexGen knee components because they were processed outside validated cleaning parameters, potentially leaving residual particulate.
GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.
Biomet, Inc. is recalling four Echo Bi-Metric hip stems because the etching on the 11mm stems incorrectly indicated they were 13mm stems.
GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the interface.
Metrex Research is recalling Pinnacle Cure Sleeves because boxes labeled for 11mm light guides contain sleeves for 7mm or 8mm guides.
Kimberly-Clark is recalling 400 Model 1000 Patient Warming System Control Units because the Error 85 alarm occasionally triggered inappropriately.
Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.
GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.
Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.
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