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.
Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.
Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.
Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.
Non-Invasive Monitoring Systems, Inc. is voluntarily recalling 91 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.
Philips Healthcare is recalling 433 MultiDiagnost Eleva X-ray systems worldwide due to potential damage to system cables from repeated movement.
Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.
Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.
Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.
Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.
Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.
App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.
Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.
Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.
Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.
Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.
Stryker is recalling T5 Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.
General Electric is recalling 3,796 Revolution XR/d digital radiographic imaging systems worldwide due to a reported incident where an operator's finger was pinched.
General Electric is recalling 3,796 Definium 8000 Digital Radiographic Systems because an operator's finger was pinched between the fixed roller and the gliding tabletop.
MicroAire Surgical Instruments is recalling 15 Lipofilter 3000 fat collection canisters because they were not manufactured under Good Manufacturing Procedures, potentially preventing proper sterilization.
Philips Healthcare is recalling 11 mobile X-ray systems because they may generate unintended radiation pulses when switched off or parked.
Aesculap Implant Systems is recalling eight Columbus Tibia Plateau components because they were found out of specification during internal quality inspection.
General Electric is recalling 3,796 Proteus XR/a Radiographic Systems worldwide because an operator's finger was pinched between the fixed roller and the gliding tabletop.
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers nationwide distribution across 23 states.
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes. The recall covers syringes and kits distributed nationwide.
Looking for a different category? Browse all recalls.