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.
Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.
Ventana Medical Systems has recalled 9,214 BenchMark ULTRA and DISCOVERY ULTRA instruments due to potential fluid leak that could cause electrical short circuit, smoke, and fire.
Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.
Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.
Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.
RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm because the set screw may loosen due to a manufacturing defect, creating a fall hazard.
Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
InfuTronix is recalling Nimbus PainPro ambulatory infusion pumps after an unreleased software version was installed in error. The defective units may impact patient safety.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
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