Category
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.
Applied Medical Technology is recalling NutraGlide 5 F-6 F x 55 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.
Medline is recalling 65 reprocessed LigaSure Blunt Tip sealer/dividers, 23 cm, because certain areas of the device can trap residual material that may become dislodged.
Medline is recalling 4,226 reprocessed LigaSure Exact dissectors, 21 cm, because certain areas of the device can trap residual material that may become dislodged.
Abbott Laboratories is recalling 833 Alinity hq Analyzers because a software issue means the system does not visibly flag results when saturation is present, which may give incorrect results.
Medline is recalling one reprocessed LigaSure Impact Curved Large Jaw sealer/divider because certain areas of the device can trap residual material that may become dislodged.
Medline is recalling 1,446 reprocessed LigaSure Blunt Tip sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.
Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.
Medline is recalling 60,917 reprocessed LigaSure Blunt Tip sealer/dividers, 37 cm, because certain areas of the device can trap residual material that may become dislodged.
Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.
Covidien is recalling 3,263 Signia Small Diameter Curved Tip Intelligent Reloads because a manufacturing issue can allow internal components to move during firing, risking uncontrolled motion.
Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Medline is recalling 57,244 reprocessed LigaSure Maryland Jaw sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Olympus is recalling 1,528 ShockPulse Lithotripsy Transducers because the device may fail to start or stop shortly after starting, and the handpiece body may heat up during clinical use.
Medline is recalling 4,007 reprocessed LigaSure Maryland Jaw sealer/dividers, 23 cm, because certain areas of the device can trap residual material that may become dislodged.
GE Healthcare is recalling 2,857 FLEX-3S2P lithium-ion batteries used with patient monitors because they can lose the capability to hold charge and provide backup power.
Siemens Healthcare Diagnostics is recalling 34 units of IMMULITE 2000 Oak Mix Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
Applied Medical Technology is recalling NutraGlide 6 F-8 F x 55 nasal feeding tubes with stylet and ENfit from one lot because the tube may be occluded.
Shimadzu is recalling 1,766 ceiling type X-ray tube supports, models CH-200 and CH-200M, because the mounting shaft may break and the tube assembly could come off.
Abbott Medical is recalling 722 Liberta RC deep brain stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
Philips Respironics is recalling 56 SimplyGo Mini standard battery kits because a defective chip can make the battery fail, shutting down the concentrator and stopping oxygen delivery.
NeuroLogica is recalling 236 GM85 digital mobile X-ray systems because the four M5 bolts securing the tube head unit to the arm may loosen or fracture from metal fatigue.
Sonesta Medical is recalling 10 Sonesta 6210 video urodynamics procedure tables because an inadequate weld on the backrest bracket can result in the backrest dropping.
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