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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.
Becton Dickinson is recalling Bard MyPICC Kits because they contain surgical gowns subject to a supplier recall.
Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.
Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.
Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post within the inner packaging, resulting in loose devices and coating debris.
Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.
Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1 due to an observed internal repetitive software glitch.
Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.
Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.
Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.
Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.
The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.
Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.
Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.
Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.
Cardiac Assist, Inc. is recalling 15 TandemHeart pump kits due to an assembly error that may prevent the device from priming.
Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components that may increase the risk of needle sticks.
Remel Inc. is recalling 250 units of the SWIN 2017 database (Model YSW4000) due to the potential for out-of-range microbial results.
Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.
BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.
The Magstim Company Limited is recalling 71 Horizon PSU Stim Interconnecting Cables because the high-voltage cable may fail. The device is used for treating Major Depressive Disorder.
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