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 449 boxes of Ray-Cot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.
American Surgical Company is recalling 24 boxes of Delicot non-xray sponges because defective packaging compromises sterility.
American Surgical Company is recalling 182 boxes of strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall affects 4 boxes distributed worldwide.
American Surgical Company is recalling 7 boxes of Uniqcot sponges because defective packaging may compromise sterility. The product was distributed worldwide.
American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling tonsil sponges due to packaging defects that compromise sterility. The recall covers four boxes distributed worldwide.
American Surgical Company is recalling 23 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 barrier packaging could compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 78 boxes distributed worldwide.
American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility. The product is distributed worldwide.
American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling specific lots of strung cotton balls because defective packaging may compromise sterility.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes distributed worldwide.
American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 boxes distributed worldwide.
American Surgical Company is recalling 13 boxes of strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.
American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.
American Surgical Company is recalling 113 boxes of Delicot 6 mm x 50 mm sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 35 boxes of Americot Blue sponges because defective packaging may compromise sterility.
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