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 Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 boxes distributed worldwide.
American Surgical Company is recalling 41 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 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 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.
American Surgical Company is recalling 237 units of 1-inch strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling 114 cases of Ultracot sponges because defective packaging compromises sterility.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.
American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 409 boxes of Delicot sponges because defective packaging may compromise sterility.
Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.
American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal sponges because defective packaging compromises sterility.
American Surgical Company is recalling 99 units of Delicot 4 mm x 50 mm sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 27 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Biomet, Inc. 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 Policot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.
Biomet, Inc. 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 Ultracot sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
Biomet, Inc. 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 45 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 37 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
American Surgical Company is recalling 99 boxes of Delicot 4 mm x 50 mm sponges because defective packaging compromises sterility.
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