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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.
Philips is recalling Intera 1.5T R11 MRI systems because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could contact patients and cause skin injuries.
Philips is recalling Enterprise 1.5T MRI scanners (Model 781145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.
LeMaitre Vascular is recalling Pruitt Irrigation Occlusion Catheters (Catalog Numbers 2102-09, E2102-09) due to incomplete sterile barrier seals found during internal testing. The defect affects approximately 26,872 units distributed nationwide and internationally.
Philips is recalling Intera 1.5T MRI systems due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and contact patient skin during scanning.
Medline Industries is recalling Centurion Sterile Weitlaner Retractor 3 x 4 Prong units because the retractors may puncture through the sterile packaging. The product is distributed nationwide.
Klinika Medical is recalling the KliniTray tissue resection margin examination board (Model 2001105-F) due to potential microbial contamination. The device was distributed nationwide in Massachusetts.
Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.
KliniTray Platte Faxitron sterile tissue resection margin examination boards (Model 2001155-F) are being recalled due to potential for microbial contamination. Affected units were distributed nationwide.
Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrectly sized coils in affected lots. The devices are used for vascular embolization procedures.
Philips is recalling SmartPath to dStream 3.0T MRI systems (Model 782145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.
AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a raw material defect in surgical needle coating that may cause diminished performance or coating removal during use.
Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.
Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.
Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin injuries.
Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.
Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.
Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.
Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.
Philips is recalling Intera 1.0T Power/Pulsar MRI systems (Model 781103) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and injure patients during scanning.
Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.
Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and create sharp edges that could injure patients during scanning.
Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3012) due to mislabeling. Thirty-four weights distributed nationwide are affected.
AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.
Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.
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