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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.
Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.
Olympus Corporation recalls Tracheal Intubation Fiberscope Models LF-P and LF-V nationwide. The device can become lodged in the endotracheal tube connector due to oversized diameter.
Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.
Olympus is recalling 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
The GS70 Salus Surgical Table may continue moving after the control button is released if communication between the control pendant and table is interrupted. This affects 110 units distributed across the US and Australia/New Zealand.
Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.
The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.
Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.
Oculus Pentacam AXL Wave optical devices may have insufficient anti-reflective coating, potentially causing inaccurate axial length measurements used in eye surgery planning.
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.
Olympus is updating labeling for 363 Visera Hysterovideoscope devices nationwide to correct ethylene oxide sterilization parameters and eliminate certain reusable cleaning brush recommendations.
Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
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