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.
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urethral catheters due to a potential defect in the distal tip.
Carefusion 2200 Inc is recalling Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.
Siemens is recalling syngo.via RT Image Suite software versions VB30 and VB40 because modified MR image orientations may result in incorrect geometry and radiation treatment plans.
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Medtronic is recalling Accurian RF Ablation Cannulas because the probe may catch on a lip inside the hub, causing insertion difficulty.
U&I Corp. is recalling six ANAX 5.5 Poly-Reduction Screws because they were laser etched with the wrong size (6.0x45 instead of 6.0x50).
Medtronic is recalling Accurian RF Ablation Cannulas because the probes may catch on a lip inside the hub, causing insertion difficulty.
Medtronic is recalling Accurian RF Ablation Cannulas because the probes catch on a lip inside the hub, causing insertion difficulty.
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches on a lip inside the hub, causing insertion difficulty.
Smith & Nephew is recalling 12 TRIGEN intramedullary nail sleeves because a manufacturing error led to improper re-sterilization of the polyethylene material.
NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.
LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.
CME America is recalling BodyGuard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
CME America, LLC is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that may cause over-infusion or under-infusion of therapy.
CME America is recalling BodyGuard Microset infusion sets because delivery inaccuracy could cause over-infusion or under-infusion of therapy.
CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
CME America is recalling Standard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.
CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard Microset infusion sets due to delivery inaccuracies that may cause over- or under-infusion of therapy.
Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
CME America, LLC is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over-infusion or under-infusion of therapy.
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