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.
Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.
Philips is recalling 20 Integris Allura 9 systems because a capacitor may fail, preventing image acquisition.
Materialise N.V. is recalling TRUMATCH Orthognathics Genioplasty Surgical Kits because the package labeling indicates a different plate than the one actually contained in the kit.
Arthrex, Inc. is recalling 20 units of Low Profile Screws because they are 6 mm longer than intended. The defect may affect bone fixation.
Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.
Philips is recalling 128 Allura CV20 X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.
Philips is recalling 69 OmniDiagnost Eleva Systems because a capacitor may fail, preventing image acquisition.
Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.
Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.
CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.
Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.
Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.
Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.
Maquet Cardiovascular is recalling Getinge 88-Series washer disinfectors because ruptured spot welds may cause water leakage, posing slip and infection risks.
Cardinal Health is recalling Monoject Hypodermic Safety Needles that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.
Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.
RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.
RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.
Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.
RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.
RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.
RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.
RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.
Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.
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