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.
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.
MERCHSOURCE LLC is recalling a handheld ultraviolet-C germicidal wand (model 1013622) due to excessive ultraviolet-C radiation emission. Consumers should stop using the product immediately.
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.
Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.
Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.
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