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.
Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.
GE Healthcare is recalling AW Server software due to a defect where patient data from one individual may be displayed in the Results Viewer for a different patient.
Heritage Labs is recalling 25 Path Study Extra Supplies Kits because they contain blood collection tubes with a Lithium Heparin contaminant that could cause erroneous lab results.
Transonic Systems Inc. is recalling HCS3011 and HCS3021 AV Loop Kits due to complaints of blood leakage. The kits are used for cardiovascular status assessment.
Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.
GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.
Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.
Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode patient identification barcodes.
Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.
GE Healthcare is recalling 48 Innova IQ systems manufactured between March 2010 and July 2011 because a safety label is missing from the gantry pivot section.
Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.
Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.
Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.
Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.
Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.
EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.
Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.
Biomet U.K., Ltd. is recalling 430 Oxford Uni Knee System Toffee Hammers because excessive use may cause the head to detach from the handle.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.
Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.
Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.
Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.
Toshiba is recalling 233 Aplio 500/400/300 diagnostic ultrasound systems due to startup issues that may cause system damage.
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