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.
American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers three boxes distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 38 boxes distributed worldwide.
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is distributed worldwide.
American Surgical Company is recalling 70 units of strung cotton balls because defective packaging may compromise sterility.
American Surgical Company is recalling 15 boxes of Ultracot sponges because defective packaging may compromise sterility.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
American Surgical Company is recalling Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall affects 266 boxes distributed worldwide.
American Surgical Company is recalling 315 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Delicot X sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
American Surgical Company is recalling Telfa 1" x 1" neurosurgical and nonneurosurgical sponges because defective packaging compromises sterility.
American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.
American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers two boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.
American Surgical Company is recalling Telfa neurosurgical sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 10 boxes of non-strung cotton balls due to packaging defects that compromise sterility.
Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.
American Surgical Company is recalling 22 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 287 boxes of Delicot sponges because defective packaging may compromise sterility.
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