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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.
Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.
Volcano Corp is recalling 227 Intravascular Ultrasound Imaging and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia system that may impact Fraction Flow Reserve calculations.
RTI Surgical is recalling 25 units of the Songer Spinal Cable System because the box end label incorrectly identifies the material as Titanium instead of Stainless Steel.
Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.
Stradis Healthcare is recalling surgical shoulder packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall by Medtronic.
Stradis Healthcare is recalling surgical and general surgery packs because they contain Devon Light Gloves, a component being recalled by Medtronic.
Stradis Healthcare is recalling Stradi 4500 convenience kits because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Face Lift Packs because they contain a Devon Light Glove that is being recalled by its manufacturer, Medtronic.
Stradis Healthcare is recalling Tummy Tuck Packs because they contain a Devon Light Glove component that is subject to a separate recall by Medtronic.
Synthes is recalling three units of a titanium end cap for tibial nails because they were shipped before a required internal inspection was completed.
Stradis Healthcare is recalling Vaginal Rejuvenation Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Blepharoplasty Packs because they contain Devon Light Gloves, which are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling surgical hand packs because they contain Devon Light Gloves, a component recalled by manufacturer Medtronic.
Stradis Healthcare is recalling Podiatry Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Upper Extremity Packs because they contain a Devon Light Glove component being recalled by Medtronic.
Allergan is recalling 9 units of expired Natrelle 410cc Re-Sterilizable Breast Implant Sizers because they were shipped to the user level.
Stradis Healthcare is recalling Advanced Vein Care kits because they contain a Devon Light Glove component recalled by Medtronic.
Stradis Healthcare is recalling three Laser Evlt Packs and Laser One Leg Evlt kits because they contain a Devon Light Glove component recalled by Medtronic.
Stradis Healthcare is recalling Vasc Custom Kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Stradis Healthcare is recalling General Packs that contain Devon Light Gloves. The recall is necessary because the glove manufacturer, Medtronic, is recalling the specific glove component.
Stradis Healthcare is recalling Minor Pack and Minor Pack II surgical kits because they contain a recalled Devon Light Glove component.
Stradis Healthcare is recalling Vein & Vascular Packs because they contain a Devon Light Glove component that is being recalled by its manufacturer, Medtronic.
Stradis Healthcare is recalling Head & Neck Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Lima Pack surgical kits because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling 15 endovenous kits because they contain Devon Light Gloves, a component recalled by Medtronic.
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