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.
Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.
American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
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 442 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.
American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.
American Surgical Company is recalling 87 boxes of strung cotton balls due to packaging defects that compromise sterility.
Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.
GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 37 boxes distributed worldwide.
American Surgical Company is recalling Telfa 1" x 3" sponges because defective packaging compromises sterility. The recall covers 57 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 Delicot sponges because defective packaging may compromise sterility. The recall covers 343 boxes distributed worldwide.
American Surgical Company is recalling 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.
American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.
American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The affected products were distributed worldwide.
American Surgical Company is recalling 11 boxes of cylindrical sponges because defective packaging may compromise sterility.
B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.
American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.
American Surgical Company is recalling Telfa 1/2" x 1/2" sponges because defective packaging may compromise sterility. The recall covers 24 boxes distributed worldwide.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 6 boxes distributed worldwide.
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