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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.
BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs (Lot 6066752) containing Sol-M syringes. Approximately 22 units distributed nationwide in the US have been affected.
The FDA is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes under a voluntary recall from the syringe manufacturer affecting nationwide distribution.
McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.
Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.
Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.
Alcon is recalling ClearCut S and A-OK ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 5,039 units were distributed nationwide and internationally.
Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery and may not perform as intended.
Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.
Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.
Medline is recalling 964 units of multiple medical procedure kits due to slight dimensional variations that may cause difficulty fitting components into the outer canister. No injuries or illnesses have been reported.
Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.
Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.
Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.
Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.
FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
Alcon is recalling 18,726 ClearCut ophthalmic knives worldwide due to reports of inadequate sharpness. The defect could compromise surgical precision during eye surgery.
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to increased complaint reports related to blade sharpness. Healthcare providers should not use affected units pending further evaluation.
Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.
Alcon Research LLC is recalling 7,108 ClearCut and A-OK ophthalmic surgical knives due to increased complaint reports about blade sharpness. The affected knives were distributed nationwide and internationally.
Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.
Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.
Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.
Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.
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