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.
Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.
Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.
Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices because the internal patient label may be incorrect, although the product itself is correctly identified.
Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.
Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.
Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.
Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.
Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.
Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.
Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.
L3 Security & Detection is recalling 471 Examiner 3DX 6000 cabinet X-ray systems used for airline baggage screening due to shielding gaps that may cause excessive X-ray emissions.
Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.
Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.
Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.
Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.
Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.
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