FDA•MODERATE
i-STAT EG7+ Cartridge
Abbott recalls i-STAT EG7+ cartridges (03P76-25) over inaccurate PCO2/pH results.
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Medical Devices Recalls
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FDA•LOWPALAMIX uno Mixing UnitHeraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
2 products
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•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEPhilips Achieva 1.5T MREPhilips recalls Achieva 1.5T MRE over stiffness value errors from incorrect voxel size settings.
19 products
FDA•MODERATEHiResolution Bionic Ear 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•MODERATEDisposable Mixing Bowls with SpatulaZimmer is recalling Disposable Mixing Bowls with Spatula due to compromised sterile barrier seals that may lead to infection.
FDA•MODERATEMilestone Vacuum Bag SU Large Specimen ContainerMilestone is recalling Vacuum Bag SU Large specimen containers (Model 68409SS) due to possible reagent leakage.
FDA•MODERATEHealthmark Mesh Style Tip ProtectorsHealthmark is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) because they lack required FDA clearance.
FDA•MODERATEKiwi Omni Vacuum Delivery SystemClinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.
FDA•MODERATEGenius Digital Diagnostics System Review Station DisplayHologic is recalling Genius Review Station displays (Model CMP-01669) due to unauthorized user modifications to validated monitor settings.
FDA•MODERATEWindstone Custom Convenience Kits Pre Op KitWindstone recalls Custom Convenience Kits Pre Op Kit (Part AMS14433) due to potential IV backflow and priming issues.
3 products
FDA•MODERATEMicro-X Rover Mobile X-ray SystemMicro-X is recalling the Rover Mobile X-ray System due to a generator malfunction that can render the device inoperable.
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•MODERATEFoundationOne CDx Sequencing Agent SEQ0067Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
FDA•MODERATELSL Infant Central Line Dressing Change KitLSL Healthcare recalls Infant Central Line Dressing Change Kit (Model 2925H) due to non-sterile alcohol prep pads.
6 products
FDA•MODERATEArrow Echogenic Introducer NeedleArrow recalls Echogenic Introducer Needle due to incorrectly manufactured liquid adhesive.
13 products
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 recalls Flamingo Funnel Small over sterilization drape nonconformance.
3 products
FDA•MODERATEOlympus OER-ELITE Connecting TubesOlympus recalls OER-ELITE connecting tubes (MAJ-2110) due to premature lock lever failure.
12 products
FDA•MODERATEnanOss 3D Advanced Bone Graft SubstituteXTANT Medical is recalling nanOss 3D bone graft substitutes due to an incorrect five-year shelf life label.
FDA•MODERATEAvitene Ultrafoam Microfibrillar Collagen HemostatDavol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.
FDA•MODERATEGentuity HF-OCT Imaging SystemGentuity is correcting HF-OCT Imaging System software (versions 21.11–23.3.13) to prevent inaccurate longitudinal measurements during imaging.
FDA•MODERATEMedline Namic GuidewiresMedline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.
28 products
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline is recalling convenience kits containing select 10mL polycarbonate syringes due to potential cracking or breakage of the syringe barrel and/or plunger, which could result in loss of sterility and potential patient infection.
21 products
FDA•MODERATELeadCare II Blood Lead Test KitsMagellan recalls LeadCare II blood lead test kits over false elevated results from certain micro-collection devices.
4 products
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATESoft-Vu Angiographic CatheterAngiodynamics recalls Soft-Vu Angiographic Catheters due to guidewire passage defect.
20 products
FDA•CRITICALMedline Namic Angiographic Control SyringesWindstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEPhilips Spectral CT on RailsPhilips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.
FDA•MODERATECytal Wound Matrix 2-Layer 5x5 cmCytal Wound Matrix 2-Layer 5x5 cm recalled over out-of-specification endotoxin results.
5 products
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•CRITICALB. Braun STREAMLINE Bloodline SetB. Braun recalls STREAMLINE bloodline sets for Dialog DR over arterial line air bubble risk.
6 products
FDA•MODERATEElegance Anterior Cervical PlatesClariance-SAS is recalling Elegance Anterior Cervical Plates due to the presence of burrs on the finished product.
2 products
FDA•MODERATEInstinct Plus Endoscopic Clipping DeviceWilson-Cook Medical is recalling the Instinct Plus Endoscopic Clipping Device due to a potential for the device to malfunction.
FDA•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for incorrect antimicrobial susceptibility testing results.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software because the MAFA ratio provides unreliable prognostic data for aneurysm treatment decisions.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may detach from the bladder, preventing the device from maintaining pressure.
FDA•CRITICALMedline Convenience Kits with Namic RA SyringesMedline recalls convenience kits with Namic RA syringes over risk of loose connection or disconnection during use.
25 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.
FDA•MODERATESpacelabs Multi-parameter Command Module Model 91496Spacelabs is recalling Model 91496 Multi-parameter Command Module due to circuit board issue causing inaccurate cardiac output readings.
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
FDA•MODERATEXTANT MEDICAL Xpress Pedicle Screw SystemXTANT MEDICAL is recalling Xpress Pedicle Screw System 6.5 x 50 mm (X073-6555-DL) due to mislabeling identifying incorrect screw length.
FDA•MODERATETornier HRS Max Tuberosity Body and Trial PartsTornier is recalling shoulder system components incorrectly labeled as HRS Max parts, as they are incompatible with the HRS Max system.
FDA•MODERATEMedline Anterior Hip Pack Biopsy ValveMedline is recalling Anterior Hip Packs containing Olympus biopsy valves over risk of rubber fragment detachment.
8 products
FDA•MODERATESIGNA Premier MR Scanner Magnet FittingsGE Healthcare is recalling SIGNA Premier MR scanners due to ferrous magnet fittings that could cause personnel injury during service.
FDA•MODERATEMedtronic MiniMed Insulin PumpsMedtronic MiniMed recalls all Paradigm, 600, and BLE 700 series insulin pumps over insulin delivery errors that can cause severe hypoglycemia or ketoacidosis.
14 products