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.
Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.
Dexcom, Inc. is recalling Dexcom ONE+ iOS CGM App versions 1.5.0 and 1.6.0 due to a software defect that can delay glucose alerts and notifications, risking delayed detection of low or high blood sugar events.
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.
The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter is being recalled because of incomplete seals on the sterile product. 449 units are affected.
Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.
Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect may compromise sterility.
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.
Dexcom G7 CGM iOS and watchOS app versions 2.9.0 through 2.11.2 are being corrected because a software defect can delay glucose value and alert processing.
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on sterile product packaging that could compromise sterility.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters with incomplete seals on sterile packaging. The defect may allow contamination of the sterile product.
Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.
GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected worldwide.
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.
DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.
GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.
DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.
Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.
GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.
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