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.
Valeritas is recalling DEMO No Needle Corrugated Cartons because there is a potential for the units to contain a needle.
Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.
Valeritas is recalling 852 DEMO No Needle Corrugated Cartons because they may contain a needle. The units were distributed nationwide in the U.S.
Baxter Healthcare is recalling 504 TherMax Blood Warmer Units because they may not meet electrical safety standards for protective earth connections.
Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.
Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.
Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.
LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.
Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.
Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.
Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.
Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Centurion Medical Products Corporation is recalling 200 Port Access Infusion Kits with 1-inch needles distributed in Illinois due to a supplier-initiated recall.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.
Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.
Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
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