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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.
The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.
FDA Class II recall of Palindrome SI Chronic Catheter Sport Packs by Covidien LLC due to potential failure to meet antimicrobial specifications.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.
Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.
Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.
GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.
Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.
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