FDA•MODERATE
QuickVue Dipstick Strep A Test
Quidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
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Medical Devices Recalls
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FDA•MODERATELVIS Intraluminal Support DeviceMicroVention recalls LVIS Intraluminal Support Devices (REF 214022-CAS, 214518-CAS, 213517-CAS) due to dimensional nonconformance risking vessel injury or thrombosis.
FDA•MODERATEDePuy Synthes Attune Revision Hinge Femoral ComponentDePuy Synthes is recalling the Attune Revision Hinge Femoral component due to a potential loss of sterility from packaging defects.
9 products
FDA•MODERATEGrace Medical Stapes ProsthesisGrace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
FDA•MODERATEepoc BGEM BUN Test CardSiemens is recalling epoc BGEM BUN Test Cards due to the risk of inaccurate pH and carbon dioxide results that may lead to improper treatment.
FDA•MODERATEPhilips Bridge Prep KitMerit Medical Systems is recalling the Philips Bridge Prep Kit due to potential catheter resistance during use.
4 products
FDA•CRITICALCook Centimeter Sizing CatheterCook is recalling Centimeter Sizing Catheters due to a risk of marker band breakage, which may cause vessel injury or life-threatening harm.
3 products
FDA•MODERATEda Vinci X and Xi Surgical System Universal Surgical ManipulatorIntuitive Surgical is recalling USM arm sub-assemblies for da Vinci X and Xi systems due to a risk of internal screw breakage.
2 products
FDA•MODERATEOne Step 10A In Vitro Diagnostic TestDFI is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
7 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsWindstone Medical is recalling Angio Pack kits containing Medline Namic syringes due to a risk of adapter disconnection and potential injury.
FDA•MODERATEi-STAT Blood Gas CartridgesAbbott is recalling i-STAT EG7+, EG6+, and G3+ cartridges due to inaccurate blood gas readings that may lead to incorrect clinical decisions.
3 products
FDA•MODERATEBiofire Spotfire Respiratory/Sore Throat PanelBiofire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEErbe Medical ERBEFLO CleverCap CO2 Tubing/Cap SetsErbe Medical is recalling ERBEFLO CleverCap CO2 tubing and cap sets due to a risk of unintended water flow and potential respiratory injury.
3 products
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
FDA•MODERATEDisposable Mixing Bowls with SpatulaZimmer is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to compromised sterile barrier seals.
FDA•MODERATEBoston Scientific LUX-Dx II Arrhythmia DetectorBoston Scientific is recalling LUX-Dx II arrhythmia detectors due to a software error that prevents proper monitoring and data collection.
2 products
FDA•MODERATEMicro-X Rover Mobile X-ray GeneratorMicro-X is recalling the X-ray generator in Rover Mobile X-ray Systems due to a malfunction that can make the device inoperable.
FDA•CRITICALAIDBAG First Aid Kits with McKesson TRUE Metrix PRONorth American Rescue is recalling AIDBAG first aid kits with McKesson TRUE Metrix PRO glucose meters over E-5 error code software defect risking treatment delays.
2 products
FDA•MODERATEStraumann n!ce PMMA Full-arch RestorationStraumann is recalling n!ce PMMA Full-arch Restoration abutments (Article 010.0304) due to an incorrect screw seat interface.
2 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATEImmy Myco DDR Trident Neutralization Buffer BImmuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.
FDA•MODERATESpacelabs Ultraview SL Command ModuleSpacelabs is recalling the SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
FDA•MODERATEGE Revolution CT SystemsGE is recalling Revolution CT systems due to a security vulnerability in the AW Server software used with the CT Smart Subscription feature.
7 products
FDA•MODERATEOxoid Salmonella 9-O Agglutinating SeraRemel Europe is recalling Oxoid Salmonella 9-O Agglutinating Sera due to potential cross-reactivity and misidentification risks.
FDA•MODERATEAvitene Ultrafoam Microfibrillar Collagen HemostatDavol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.
FDA•MODERATEOlympus OER-ELITE Endoscope Reprocessor Connecting TubesOlympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (model MAJ-2110) due to potential premature failure of the lock levers.
12 products
FDA•LOWHeraeus PALAMIX uno Mixing SystemHeraeus is reducing the shelf life of PALAMIX uno mixing systems to 17 months due to a risk of the mixing rod detaching during use.
2 products
FDA•CRITICALVOCSN V+Pro Respiratory SystemVentec is recalling VOCSN V+Pro respiratory systems (REF: PRT-01198-000, PRT-01185-000) due to potential oxygen leaks that may increase fire risk.
FDA•MODERATEDEX Ophthalmic Tissue ForcepsKatalyst Surgical is updating the Instructions for Use for DEX Ophthalmic Tissue Forceps and 23ga DEX NanoTapered AWH Forceps.
12 products
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth is recalling BioCera Fibers bone void filler products that do not meet standard manufacturing specifications.
2 products
FDA•CRITICALOmnicell i.v.STATION Syringe Label StockOmnicell is recalling i.v.STATION syringe label stock due to the potential for mislabeled IV medication syringes.
FDA•MODERATEHamilton AutoLys STAR Protocol Configuration Tool SoftwareFoundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR due to risk of spontaneous software closures during protocol execution.
FDA•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for inaccurate antimicrobial susceptibility testing results.
FDA•CRITICALMedline Namic Angiographic ManifoldMedline is recalling custom Namic Angiographic Manifolds due to the presence of particulate matter within the fluid path.
14 products
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•MODERATEGentuity HF-OCT Imaging SystemGentuity is correcting the HF-OCT Imaging System (Model G10-01) to address a software issue that may cause inaccurate length measurements.
FDA•MODERATEOlympus Thunderbeat II ShearsOlympus is recalling Thunderbeat II Shears (Model TB2-0520FC) due to the risk of a distal tip component detaching during use.
4 products- Device RecallFDA•MODERATEGenius Digital Diagnostics System Review Station Display
Hologic is correcting Genius Review Station displays due to unauthorized configuration changes that deviate from validated settings.
FDA•MODERATEHiResolution Bionic Ear System M Zn-Air Battery PakAdvanced Bionics is recalling M Zn-Air Battery Paks for cochlear implants due to a non-compliant battery door design.
2 products
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to a risk of fractures at the distal shaft tip.
FDA•MODERATEFoundationOne CDx Sequencing Agent SEQ0067Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
FDA•MODERATEProdisc C SK U.S. Cervical Disc ImplantCentinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up between 5mm and 6mm sizes.
2 products
FDA•CRITICALBoston Scientific Essentio, Proponent, Accolade, and Altrua 2 PacemakersBoston Scientific is updating software for Essentio, Proponent, Accolade, and Altrua 2 pacemakers to address dual-chamber device performance.
3 products
FDA•MODERATECytal Wound Matrix 2-LayerIntegra LifeSciences is recalling Cytal Wound Matrix 2-Layer 5x5 cm dressings due to out-of-specification endotoxin results.
5 products- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software due to unreliable MAFA ratio data that may lead to incorrect clinical decisions.
FDA•CRITICALB. Braun Hemodialysis BloodlinesB. Braun is recalling Streamline Bloodline Sets for Dialog iQ machines due to a risk of air bubble accumulation in the arterial line.
6 products- Device RecallFDA•MODERATELeksell Vantage Arc System
Elekta is recalling the Leksell Vantage Arc System due to a defect in the locking mechanism that may cause coordinate shifting during procedures.
FDA•MODERATEMedline Neuro SpongesMedline is recalling various neuro sponges due to higher-than-expected endotoxin levels.
38 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsAmerican Contract Systems is recalling Medline Namic Angiographic Control Syringe kits due to a risk of syringe disconnection during use.