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.
Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.
Edwards Lifesciences is recalling Vent Catheters because the white plastic coating on the stylet may disrupt. The action covers 157,305 units distributed worldwide.
Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.
Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.
Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP Assay reagents because approximately 2,000 ReadyPacks contain an incorrect human-readable side label.
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration instead of 2 years.
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.
Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration period instead of the correct 2-year period.
Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration instead of the correct 2-year period.
Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.
Medacta is recalling GMK Intramedullary Extension Rods 100 mm after three reported cases of breakage during total knee replacement surgeries.
GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.
Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.
Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.
Fisher and Paykel Healthcare is recalling IW900-Series Infant Warmers and spare parts because a broken nut may allow the heater head to swing and injure infants.
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