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.
Medline Industries, LP is recalling specific Medline NEURO PACK convenience kits because they may contain low levels of Bacillus species contamination.
Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.
Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.
AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.
Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.
Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.
Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.
Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.
Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.
Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits do not meet sterility release criteria.
ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.
Abiomed is recalling ABIOMED Introducer Kit 23 Fr due to potential sheath leakage from manufacturing defects. The leakage risk is not visually detectable and affects all current batches worldwide.
ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.
Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
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