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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.
Hill-Rom is recalling 726 SlingBar Standard units because a retrospective review found a potential for impalement if a person falls onto the hooks.
AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.
Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.
Biomet is recalling 8 units of Active Articulation E1 hip bearing implants because outer and inner labels display incorrect or conflicting outer diameter sizes.
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.
Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
Invatec Llc is recalling 177 Diver C.E. aspiration catheters because the labeled indications for use were not included in the existing regulatory clearance.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.
Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.
Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.
Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Bion Enterprises is recalling 504 units of IgG FITC Conjugate because the labeled expiration date is one year too long.
Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.
Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.
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