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.
Olympus is recalling 1,605 Bronchovidescope BF-1T240 units because attaching non-Olympus accessories may have loosened the instrument channel port.
Olympus is recalling 655 Bronchovideoscope BF-Q180-AC units because using non-Olympus accessories may have loosened the instrument channel port.
Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Radiometer America Inc. is recalling ABL90 FLEX analyzers with software version 3.3MR1 or below because they may aspirate calibration solution instead of rinse solution.
Oridion Medical is recalling 56 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling three Capnostream20 M bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.
Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.
Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.
Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.
Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling specific ACCOLADE pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.
Boston Scientific is recalling PROPONENT pacemakers because hydrogen exposure may cause the battery to deplete faster than expected, requiring early replacement.
Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.
Agfa N.V. is recalling 108 DX-D 600 X-ray systems because support cables may break, posing a risk of the equipment falling.
Bausch & Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the body of the device.
GE Medical Systems is recalling 516 Discovery MR750w MRI systems because a small area on the bore surface can become warm enough to cause a serious burn if a patient touches it without proper padding.
Philips is recalling NTEGRIS Allura 9 0 FDXD systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Philips is recalling AlIura Xper F010 F systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.
Philips is recalling INTEGRIS SUITE systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.
Philips is recalling 5,115 Allura Xper F010/10 DRTables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
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