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.
Inovo, Inc. is recalling 117 Inovo Purefill Oxygen Compressor Model PF1100 units because the device can fail during operation.
Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.
Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.
Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors because packaging seals may separate, compromising sterility.
Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.
Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.
Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.
Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.
Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.
Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.
Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.
Stryker is voluntarily recalling 749 Performance-LOAD Ambulance Cot Fasteners because they may not fasten securely, posing a risk of injury.
Firefly Medical is recalling 239 IVEA 500A medical beds because a dowel pin could slip out, causing the bed to slump and potentially making a patient stumble.
Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.
Merge Healthcare is recalling Merge Cardio software versions 8.30.0 through 10.1.1 because images sent without an order may be matched to the wrong accession number.
GE Healthcare is recalling specific Avance CS2, Avance, and Amingo anesthesia devices because they may enter a System Malfunction state if a storage drawer closes with excessive force.
GF Health Products is voluntarily correcting Patriot homecare beds because contaminated motor housings may crack, potentially causing the head section to fall.
Accuray is recalling 40 CyberKnife Robotic Radiosurgery Systems with software version 10.6 due to a potential safety issue involving unexpected treatment robot motion when removing an accessory.
Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to discoloration and degradation of the fiberoptic bundle at the pad and box connection.
Ellman International is recalling 370 boxes of Minor Surgery Bipolar Cables because the expiration dates on the outer boxes and individual pouches do not match.
Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.
Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.
Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.
Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.
C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect may compromise product sterility.
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