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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.
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.
Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.
Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.
Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.
Smith & Nephew is recalling RENASYS EDGE 300ML canisters due to black particulate matter from the carbon filter that may enter the pump. The recall affects 6,895 units distributed in the US, Canada, and Chile.
Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.
Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.
Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.
RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.
Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.
Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.
Baxter Healthcare is recalling power cord models globally because the insulation does not meet electrical safety standards, creating a potential risk of electrical shock or fire.
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.
Medline is recalling 79 Bed Assist Bars that failed to comply with federal safety standards for adult portable bed rails. The products were manufactured after the compliance deadline.
Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.
Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.
Certain patient lift models may have a hanger bar that could come loose during use, potentially causing patient falls. Approximately 10 units distributed to TX, IL, OK, and CA are affected.
Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.
Hillrom Welch Allyn Spot Vision Screener VS100 units recalled due to power cord insulation that does not meet electrical safety standards. The affected devices may pose an electrical hazard to users.
Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.
Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.
Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
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