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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.
Sentec AG is recalling V-Sign 2 Sensors because of a problem with configuration parameter writing during manufacturing.
Teleflex Medical is recalling 611 units of TAUT Cholangiogram Catheter Intraducers because the internal packaging is missing labels. The devices were distributed to 27 states.
Terumo is recalling three Sarns System 8000 bases because they were distributed with incorrect amperage ratings on the nameplate labels.
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.3.0 and later because test results may be filed to the wrong patient containers.
GE OEC Medical Systems is recalling 17 FluoroTrak Spinal Navigation Applications because they may display incorrect instrument positions relative to reference images.
Siemens Healthcare Diagnostics is recalling 2,554 Dimension Reagent Management System power cords due to a fire hazard caused by partial cord insertion.
Stryker Spine is recalling 30 Luxor Retractor Base devices because blades may disassemble from the base, causing the retractor to collapse during use.
Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.
Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.
Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.
Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.
Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.
Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.
Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.
Smith & Nephew is recalling 2,204 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.
Tango3 LLC is recalling 44 water storage tanks with ozone disinfection systems due to quality system deficiencies and lack of assurance that systems operate at minimum ozone levels.
Apheresis Technologies is recalling 13 Plasma Pump Model PP-04a units because a rotor stopped during treatment, interrupting flow.
Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.
Transenterix is recalling SPIDER Flexible Clip Applier surgical instruments because some units may fail to close clips properly during minimally invasive procedures.
Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.
Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.
Finapres Medical Systems is recalling three Portapres blood pressure monitors in the US because the NiMh battery pack may become hot and leak.
Stryker Spine is recalling Reliance AL Implant Blockers because six reports indicated that prongs on the instruments broke during use.
Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.
Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.
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