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.
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.
Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.
Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.
Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.
Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.
Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.
bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.
AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.
bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.
Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.
Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.
Looking for a different category? Browse all recalls.