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.
Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.
Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.
Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.
Microline Surgical is recalling 540 units of Renew Fenestrated Control Tip Graspers because the jaw may break when force is applied.
Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.
Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.
Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.
Heraeus Kulzer is recalling Gluma Desensitizer Power Gel because it may extrude all at once, causing irritation, burning, or blistering to patients or dental professionals.
Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.
SCM True Air Technologies is recalling 24 JK Bariatric Beds nationwide due to lack of design controls, missing Device Master Records, and unapproved vendors.
Fujifilm Medical System USA is recalling 14 MXR-35 Diagnostic X-ray High Voltage Generators because the labeling did not include the certification statement required by 21 CFR Part 10 10.2.
Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.
Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Arrow International Inc. is recalling Arrowgard Blue and Blue Plus catheters because the packaging incorrectly lists an echogenic needle, which may not be present.
SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.
Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Siemens Medical Solutions is recalling 64 syngo Imaging XS systems because a software change may have caused the deletion of archived medical images.
The Anspach Effort, Inc. is recalling 150 Anspach Irrigation Clip 40 units because they were assembled with incorrect, smaller clips.
SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.
Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.
Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.
CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.
Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.
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