FDA•MODERATE
Selenia Dimensions Mammography Systems
Hologic is recalling 15+ models of Selenia Dimensions Mammography Systems due to a risk of loose, missing, or broken internal bolts.
2 productsMedical Devices Recalls
LatestAll recalls →
- Device RecallFDA•MODERATEMedtronic SynchroMed Flex Infusion Mode A810 Software
Medtronic is recalling A810 software for SynchroMed pumps due to a display error that can cause incorrect or failed infusion delivery.
2 products 
FDA•MODERATESwan-Ganz CathetersBecton, Dickinson and Company is recalling 15+ models of Swan-Ganz Catheters due to a risk of hub leakage or breakage.
3 products
FDA•MODERATEBD GasPak EZ Gas Generating Pouch SystemsBecton Dickinson is recalling BD GasPak EZ CO2 and Campy Gas Generating Pouch Systems due to insufficient carbon dioxide production.
2 products
FDA•MODERATEQuickVue Dipstick Strep A TestQuidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
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 compromise of the sterile barrier.
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 incorrect 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•CRITICALCentimeter Sizing CatheterCook is recalling Centimeter Sizing Catheters due to a risk of marker band breakage that may cause vessel injury or life-threatening harm.
3 products
FDA•MODERATEda Vinci X and Xi Surgical System Universal Surgical ManipulatorIntuitive Surgical is recalling the USM arm sub-assembly 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 due to a lack of 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 results 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•MODERATEERBEFLO CleverCap CO2 Tubing/Cap SetsErbe Medical is recalling ERBEFLO CleverCap CO2 tubing and cap sets due to a risk of water aspiration and potential respiratory complications.
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 a risk of compromised sterile barrier packaging.
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 System GeneratorMicro-X is recalling Rover Mobile X-ray System generators (models MXU-RV35 and MXU-RV71) due to a risk of the device becoming 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 bridges 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 loss.
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 a risk of premature lock lever failure.
12 products
FDA•LOWHeraeus PALAMIX uno Mixing SystemHeraeus is reducing the shelf life of the PALAMIX uno mixing system to 17 months due to a potential mixing rod detachment issue.
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 Bioresorbable Bone Void FillerOrthorebirth is recalling BioCera bone void filler models due to the product falling outside of standard manufacturing specifications.
2 products
FDA•CRITICALOmnicell i.v.STATION Syringe Label StockOmnicell is recalling i.v.STATION syringe label stock due to a risk of mislabeled syringes during the IV medication compounding process.
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 11mL 10/box units due to the potential for incorrect antimicrobial susceptibility testing results.
FDA•CRITICALMedline Namic Angiographic ManifoldMedline is recalling 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 recalling HF-OCT Imaging Systems running software versions 21.11–23.3.13 due to potential measurement inaccuracies.
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 sound processors 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 potential 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 pacing issues.
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 treatment decisions.