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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 JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.
Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
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.
Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.
Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.
Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.
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.
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.
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.
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.
Bard Peripheral Vascular Inc. is recalling 2,880 Atraumatic Adult Lumbar Puncture Trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally.
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 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.
Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.
Boston Scientific is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.
Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.
Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.
Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.
Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.
Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.
GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.
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