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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.
Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.
Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.
Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.
Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.
Linkbio Corp. is recalling LINK SLED Knee System prostheses due to risk of early aseptic loosening or increased wear caused by suboptimal surgical technique. The company is providing amended surgical guidelines and training.
GE Healthcare's Centricity PACS-IW radiological system can mismatch information between patients when correcting patient or study data. No illnesses reported.
Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.
Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.
Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.
GE Healthcare's Centricity Universal Viewer can mismatch patient information when correcting patient or study data, affecting 329 units distributed worldwide.
FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.
Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.
Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.
Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.
OttLite Rechargeable UVC Disinfecting Wand model UV10002M emits excessive ultraviolet radiation above safe limits. Approximately 7,376 units were distributed nationwide.
FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.
Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.
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