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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.
Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.
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.
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.
American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.
American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.
ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.
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.
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.
ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
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.
Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.
A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.
Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.
Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.
Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.
Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
Pending LLM rewrite. Source: FDA_DEVICE Z-1639-2022.
Boston Scientific ZOOM LATITUDE programmer software may have anomalies when communicating with certain Boston Scientific defibrillators, potentially affecting device programming and communication functions.
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.
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