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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.
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
Datascope Corporation is recalling 6,111 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.
Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.
Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.
RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.
Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.
Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.
The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.
OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.
OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.
CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.
CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.
Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.
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