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.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical due to a voluntary recall by the syringe manufacturer.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip syringes. The recall affects 150 units distributed nationwide.
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these components.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall. The recall affects 9 units distributed nationwide.
The FDA is issuing a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes affecting 1,029 units distributed nationwide.
BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary manufacturer recall. The affected packs were distributed nationwide in the U.S.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 196 units distributed nationwide.
Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., subject to a voluntary recall by the manufacturer.
Beaver Visitec International is recalling 59 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
Beaver Visitec International is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall by the syringe manufacturer, Sol-Millennium Medical, Inc.
Beaver Visitec International is voluntarily recalling 216 units of BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-M. The recall affects nationwide distribution.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
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.
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.
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.
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 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.
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.
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.
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