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.
Smith & Nephew is recalling 2,646 Dyonics Saw Blades because they are provided sterile but lack an expiration date on the label.
Smith & Nephew is recalling 1,410 Dyonics Saw Blades because the single-use sterile devices lack expiration dates on the label.
Smith & Nephew is recalling 8,748 Dyonics Saw Blades because the single-use sterile devices lack expiration dates on their labels.
Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.
BioMerieux SA is recalling ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips due to potential performance issues that may result in false susceptibility or intermediate results.
Siemens Healthcare Diagnostics is recalling N Latex HCY Reagent kits due to reduced stability that may cause inaccurate homocysteine test results.
DeRoyal is recalling Heart Tracecarts because they contain a sterile chest drainage product affected by a packaging configuration issue.
Quidel Corporation is recalling Influenza Transport Swab Packages because they may contain incorrect sample swabs mixed with the proper ones.
Smith & Nephew is recalling Dyonics Saw Blades because they are provided sterile but lack an expiration date on the label.
Smith & Nephew is recalling 3,462 Dyonics Saw Blades, Narrow (Product Number 3705) because the single-use sterile devices lack an expiration date on the label.
DeRoyal Industries is recalling Heart Tracecarts because they contain a Maquet Getinge chest drainage product affected by a separate packaging recall.
Smith & Nephew is recalling 4,500 Dyonics Saw Blades, Short (Product Number 3703) because the single-use sterile devices lack expiration dates on their labels.
Sage Products Inc is recalling 640 Q Care Continue Care Kits because the kit's printed expiration date is incorrect. The kits contain oral care products with an earlier expiration date than printed on the main kit.
Applied Medical Technology is recalling 110 units of the AMT Bridle Nasal Tube Retaining System because expired expiration dates are listed on the pouches.
Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device because it was reclassified from Class III to Class II, triggering new documentation requirements.
Applied Medical Technology is recalling 110 units of AMT 12-inch Right Angle Feeding Sets with Y-Ports due to expired expiration dates listed on the pouches.
Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 device because it was reclassified from Class III to Class II, triggering new documentation requirements.
Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.
GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.
Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.
Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.
Siemens is recalling 194 PRIMUS radiation therapy systems due to incorrect collimator position displays and improper weld seams at the overhead suspension.
Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.
Zimmer Biomet is recalling 4,388 Comprehensive Reverse Shoulder System Humeral Trays because they are fracturing at higher-than-anticipated rates, posing a risk of revision surgery.
Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.
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