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 is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.
Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.
bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.
Respironics is recalling 190 V680 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings and potentially causing delayed treatment.
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.
Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.
Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.
Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.
Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.
Microvention is recalling 1,187 units of Terumo AZUR CX Peripheral Coil Systems because the implant coil may be missing from the packaging.
Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.
Prollenium Medical Technologies is recalling 48,457 kits of Revanesse Versa because the product is labeled with an 18-month expiration date, but it is only approved for 12 months.
Implant Direct is recalling 78 Legacy 3 dental implants because some packages contain incorrect cover screws and extenders, which may delay surgery or require new procedures.
Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.
C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.
CooperVision is recalling specific lots of Vertex Toric contact lenses because they were manufactured with an incorrect power.
DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in surgery.
Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.
CooperVision is recalling 216 units of Vertex Toric contact lenses because they have an incorrect power than expected.
LivaNova USA Inc. is recalling five Sorin Connect Datapad devices because they have incorrect manufacturing date labels. The devices were distributed in New Jersey and California.
Taewoong Medical Co., Ltd. is recalling 178 esophageal stents because the Instructions for Use (IFUs) shipped with the devices were misprinted.
Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.
Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
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