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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 is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.
Philips Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.
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 Allura Xper FD10 imaging devices because the patient table mattress may not securely hold patients during procedures, creating a fall hazard. The recall affects 2,274 units worldwide, including 459 in the U.S.
Philips is recalling 114 units of the Allura Xper FD20/20 imaging table due to mattress defects that could cause patients to fall. 33 units are in the US; 81 are internationally distributed.
Philips Medical Systems is recalling Azurion 5 M12 imaging tables due to a mattress defect that could allow patients to fall from the table.
Philips Azurion 7 M12 patient tables are recalled due to a mattress defect that could cause patients to fall. Approximately 1,837 units are affected globally.
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 is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.
The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.
RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.
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.
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.
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.
KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.
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.
DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.
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.
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
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.
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
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