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.
ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.
Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.
Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient samples.
Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.
Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks due to incorrect labels that may cause compatibility issues with milling machines.
Hill-Rom is recalling 67 Life2000 Ventilation Systems because they pose a risk of fire under certain conditions. The devices are used in home and institutional settings.
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.
Conformis, Inc. is recalling two iTotal Hip Replacement Systems because incorrect hip components were provided in the kits.
Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because they may have holes or cracks that allow fluid to leak.
Flexicare Medical Ltd. is recalling ProVu Single Use Video Stylets with ET Tubes because over-inflated cuffs may block the airway, making it difficult to ventilate patients.
Viewray, Inc. is recalling 35 ViewRay MRIdian Linac Systems because receive coil components may reach elevated temperatures, posing a risk of burn injury to patients or users.
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen 1-2mm 0.5g units because granules may be expelled all at once, posing a risk of tissue injury.
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.
Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.
RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.
Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.
Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.
ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.
Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.
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