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.
Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.
Avid Medical is recalling 24 knee arthroscopy kits because they may contain needles with loose polypropylene foreign material.
Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.
Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Avid Medical is recalling 52 TruCustom PV Minor Pack convenience kits because they may contain needles with loose polypropylene foreign material.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.
Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and ink transfer to devices.
Keystone Dental Inc is recalling 20 Stage-1 RDS Indexed Abutments because the expiration date on the label is incorrect.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Perkinelmer is recalling seven Janus and Janus G3 automated workstations because defective circuit boards may cause horizontal motion errors and instrument downtime.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and ink transfer to devices.
Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Ortho Clinical Diagnostics is recalling VITROS Performance Verifier II Lot K4852 because it fails long-term stability requirements for the AST analyte when refrigerated.
CooperVision is recalling specific Biofinity XR Toric contact lenses because the primary blister labels incorrectly identify them as Biofinity Multifocal Toric.
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
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