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.
Philips is recalling Azurion 5 M20 imaging tables worldwide due to a mattress defect that could cause patients to fall from the table. This FDA Class I recall involves 632 units.
Philips is recalling Azurion 3 M12 patient tables due to possibility of patient falling from the table related to the mattress. The recall affects 263 units distributed in the US and internationally.
Philips is recalling the Allura CV20 patient table due to a mattress defect that could allow patients to fall. The recall affects 111 units distributed worldwide.
Philips recalls Azurion 7 M20 patient tables due to a mattress defect that could cause patients to fall. Approximately 1,480 units in the US and 2,741 units overseas are affected.
Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.
Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.
Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.
Philips is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.
Philips is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.
Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.
Augustine Temperature Management recalls 3 Hot Dog patient warming mattresses (US530) due to cable connector deflection that may cause intermittent connection failure, potentially occurring after one year of use.
Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.
RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.
KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.
XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.
Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.
RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
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