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.
Merge Healthcare is recalling 47 units of Merge LIS software because a defect causes unrelated medications to appear on patient reports.
RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.
Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.
W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.
GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.
Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.
Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.
Medline Industries is recalling 26 Quidel Triage BNP Calibrators because the product was compromised during shipment. The recall affects domestic distribution in CA, NY, TX, and VA.
Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.
Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.
Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.
Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.
Boston Scientific is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base.
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.
Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.
Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.
RTI Surgical is recalling 420 units of Streamline TL Navigation System taps because they have experienced binding with other devices.
Becton Dickinson is recalling Bard 3F SL PowerMidline Full Kits because they may lack the stylet/T-lock assembly, potentially causing procedural delays.
Thread Counsel Inc is recalling LOM Disposable Surgical Gowns due to missing labeling and potential non-compliance with FDA standards.
GE Healthcare is recalling specific PET/MR imager models due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.
Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.
Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.
Vascular Solutions, Inc. is recalling 1,680 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
Baxter Healthcare is recalling 152,539 SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.
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