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.
Nobel Biocare is recalling 594 units of NobelReplace CC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.
Nobel Biocare is recalling 72 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.
Nobel Biocare is recalling specific NobelReplace dental implants because packaging material may leave a sticky substance on the implant surfaces.
Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.
Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.
Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.
Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.
CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.
Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.
Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.
Looking for a different category? Browse all recalls.