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.
Incisive Surgical Inc is recalling 1,200 units of INSORB Subcuticular Skin Staplers (Ref 2030) due to a possible compromise of the sterile barrier integrity.
Reckitt Benckiser LLC is recalling Durex Synthetic polyisoprene condoms in New York due to insufficient data ensuring they meet internal burst pressure specifications at the end of their 5-year shelf life.
Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems because they may dispense insufficient sample volumes without suppressing potentially incorrect results.
Widex A/S is recalling two BABY440 hearing aids because they were fitted with non-tamper-resistant battery drawers. The devices were distributed in Georgia and New York.
AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.
Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.
Stryker Spine is recalling five AVS Aria Cage units because the anterior and posterior markers were placed on the incorrect sides of the device.
Implant Direct is recalling 217 units of Legacy Implant Closed-Tray Transfer components due to potential cap mislabeling. The correct part number is on the main vial label.
Agfa Healthcare is recalling 17 Enterprise Imaging Desktops because adding a comparison study may disrupt the chronological sorting of images in the Clinical Side Bar.
GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.
GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.
Becton Dickinson is recalling BD FocalPoint Slide Profiler and GS Review Station units because they may not function below 15°C. The agency states this issue has no potential to cause harm.
B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
B. Braun Medical is recalling 6,850 clamp-style catheter connectors because they may not stay closed, causing leakage or disconnection.
Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.
B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.
B. Braun Medical is recalling 1,980 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.
Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.
Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.
Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System due to observed Type III endoleaks.
Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension Endografts due to observed Type III endoleaks.
B. Braun Medical is recalling CE18TKDP catheter connectors because they may not stay closed, leading to leakage or disconnection.
B. Braun Medical is recalling 1,760 CE18TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.
B. Braun Medical is recalling 17GA Safety Tuohy Needle Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
B. Braun Medical is recalling 430 units of CONT STIM BASIC KIT W/4 IN INSUL TUOHY catheter connectors because they may not stay closed, leading to leakage or disconnection.
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