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.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.
Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.
GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.
Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.
GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.
Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.
Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.
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