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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.
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.
Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.
CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.
Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.
A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.
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