FDA•MODERATE
ZYMUTEST HIA IgG ELISA Kit
ZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
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Medical Devices Recalls
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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•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•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•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•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•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.
- Device RecallFDA•MODERATELeksell Vantage Arc System
Elekta is recalling the Leksell Vantage Arc System due to locking mechanisms that may fail to secure, causing coordinate shifts.
FDA•MODERATEMedline Neuro SpongesMedline is recalling various neuro sponges due to higher-than-expected endotoxin levels that may exceed safety specifications.
38 products
FDA•MODERATEDonJoy IceMan Classic3 Cold Therapy UnitDJO is recalling the IceMan Classic3 cold therapy unit due to a broken connector that may interrupt cold therapy.
4 products
FDA•MODERATEDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon DilatorDiversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators due to incorrect inflation tag labeling.
4 products
FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEStraumann Custom Abutment TiStraumann is recalling custom abutments manufactured with incorrect raw materials due to a production mix-up.
2 products
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEAccess Total T4 CalibratorBeckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
FDA•MODERATEFlamingo Funnel SmallSurgiSmoke Solutions is recalling the Flamingo Funnel Small due to a manufacturing nonconformance involving incompatible sterilization drapes.
3 products
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline is recalling convenience kits containing non-sterile alcohol prep pads due to potential bacterial contamination.
10 products
FDA•MODERATEMagellan Diagnostics LeadCare II Blood Lead Test KitsMagellan Diagnostics is recalling LeadCare II blood lead test kits due to the risk of false positive results.
4 products
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTOR In Vitro Diagnostic TestB.R.A.H.M.S PlGF Plus KRYPTOR (Catalog 859075N) recalled for out-of-range quality control values that may cause falsely elevated preeclampsia risk results.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may fail to maintain pressure due to a potential detachment at the welding connection.
FDA•MODERATEARTIS Pheno VE30A and VE40A Imaging SystemSiemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.
FDA•MODERATEMesh Style Tip ProtectorsHealthmark Industries is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) due to a lack of FDA clearance.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•MODERATEB Braun IV Administration SetsWindstone Medical Packaging is recalling Pre Op Kits containing B Braun IV administration sets due to potential medication backflow risks.
3 products
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEArrow Echogenic Introducer NeedleArrow is recalling the Echogenic Introducer Needle due to a manufacturing error with the device's liquid adhesive.
13 products
FDA•MODERATEARTIS pheno and ARTIS Icono Biplane X-ray SystemSiemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.