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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.
Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.
Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.
Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.
The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.
Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.
Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.
Bard Peripheral Vascular is recalling 29,870 lumbar puncture trays due to manometer failure that causes leaking and improper connections. The defect could compromise device function during lumbar puncture procedures.
Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.
Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.
Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.
Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.
Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.
Boston Scientific is recalling 7,115 units of JAGTOME REVOLUTION RX devices worldwide due to sterile barrier breach that could allow contamination.
Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.
Boston Scientific has recalled 3,578 units of the JAGTOME RX medical device due to sterility compromise from a barrier breach. Affected units were distributed worldwide.
Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.
Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.
Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.
Boston Scientific has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a compromised sterile barrier that affects device sterility. The affected devices were distributed worldwide.
Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.
Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL (Model CS203-EN, Lot Y060321-09) with defective dressing containing holes that prevent creating an occlusive seal for chest wounds.
Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.
Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.
Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.
Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.
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