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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.
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
Universal Meditech Inc. is recalling diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.
Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.
Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.
Preat Corp is recalling Neodent dental healing abutments (REF 9007124) due to a dimensional condition that may cause gaps between the abutment and implant, potentially allowing microleakage.
Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.
Universal Meditech is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.
A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
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