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.
Collagen Matrix Inc is recalling 136 units of Porcine Anorganic Bone Mineral 4.0cc because the product may contain only 2.0cc volume, resulting in mislabeling.
Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.
Swissray Medical AG is recalling three ddRCombi Plus FP X-ray systems because a lifting column component may break, causing the arm to drop and potentially seriously injure patients or users.
Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.
Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.
Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.
GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.
Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.
Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.
Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.
GE Healthcare is recalling 64 VariCam units because a collimator locking handle defect may prevent the warning circuit from detecting an unlocked state during scans.
Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.
Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.
GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.
Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.
Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.
Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.
Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.
Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.
Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.
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