FDA•MODERATE
Thermedx FluidSmart Urology Tube Set
Stryker is recalling the FluidSmart Urology Tube Set (REF LL0006) due to the distribution of nonconforming products.
Filters
Category
Agency
Severity
Date
Distributed in
Medical Devices Recalls
Back to home ←
FDA•MODERATESelenia Dimensions Mammography SystemsHologic recalls 20+ Selenia Dimensions mammography systems over loose or broken internal bolts.
2 products
FDA•MODERATEDexcom G7 CGM iOS AppDexcom recalls G7 and ONE+ iOS CGM apps over software defect that may delay glucose alerts and cause missed hypoglycemia detection.
4 products
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATELUCAS Chest Compression SystemJolife AB is recalling LUCAS 2, 3, and 3.1 chest compression systems due to missing service documentation.
2 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsWindstone Medical is recalling Medline Namic Angiographic Control Syringe kits due to a risk of adapter disconnection and potential injury.
FDA•MODERATERevolution Ascend CTGE HealthCare recalls Revolution Ascend CT systems over AW Server security vulnerability.
7 products
FDA•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) over particulate in fluid path.
14 products
FDA•MODERATEDONJOY IceMan Classic Cube Cold Therapy UnitDJO recalls DONJOY IceMan Classic Cube cold therapy units due to broken connector risk.
4 products
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) due to out-of-spec product.
2 products
FDA•MODERATEMedline Convenience KitsMedline is recalling Ancillary Pack-LF and Open Heart Anesthesia ICC-A kits due to potential issues with sterilization and packaging calibration.
58 products
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.
FDA•MODERATEOne Step 10A In Vitro Diagnostic TestDFI recalls One Step 10A diagnostic test due to lack of FDA clearance.
7 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•MODERATEDEX Ophthalmic Tissue ForcepsKatalyst Surgical recalls DEX Ophthalmic Forceps (Models DVF4019-27, DVF4005-23) over IFU corrective action.
12 products
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.
FDA•MODERATESpacelabs Ultraview SL Command ModuleSpacelabs is recalling the Ultraview SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
FDA•MODERATEProdisc C SK Implant Extra Large 5mmCentinel Spine recalls Prodisc C SK Implant Extra Large 5mm over labeling mix-up with 6mm size.
2 products
FDA•CRITICALCentimeter Sizing CatheterCook recalls Centimeter Sizing Catheter over marker band cracking risk that may cause vessel injury or death.
3 products
FDA•MODERATEBoston Scientific LUX-DX II Arrhythmia DetectorBoston Scientific is recalling LUX-DX II arrhythmia detectors (Models M302/M312) due to a failure to monitor specific cardiac conditions.
2 products
FDA•MODERATEERBEFLO CleverCap Hybrid CO2 Tubing/Cap SetsErbe Medical recalls CleverCap Hybrid CO2 Tubing/Cap Sets over water aspiration risk.
3 products- Device RecallFDA•MODERATEda Vinci Surgical System Universal Surgical Manipulator
Intuitive 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•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive is recalling SureForm 30 Gray stapler reloads due to the risk of an incomplete staple line during surgical procedures.
FDA•MODERATEMedline Kits with Webcol Alcohol Prep PadsMedline recalls kits with Webcol Alcohol Prep Pads over non-sterility risk.
10 products
FDA•MODERATEImmy Myco DDR Trident Neutralization Buffer BImmuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.
- Device RecallFDA•MODERATEATTUNE Revision Hinge Femoral LT SZ 4 CEM
Depuy Synthes recalls ATTUNE Revision Hinge Femoral LT SZ 4 CEM due to packaging adhesion that may compromise sterility.
9 products 
FDA•MODERATEepoc BGEM BUN Test CardSiemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.
FDA•MODERATEStraumann n!ce PMMA Full-arch RestorationStraumann recalls n!ce PMMA Full-arch Restoration due to incorrect screw seat interface.
2 products
FDA•MODERATEBD GasPak EZ CO2 and Campy Pouch SystemsBD recalls GasPak EZ CO2 and Campy pouch systems due to low CO2 output.
2 products
FDA•MODERATEPhilips Bridge Prep KitMerit Medical recalls Philips Bridge Prep Kit due to catheter resistance over guidewire.
4 products
FDA•MODERATEi-STAT EG7+, EG6+, G3+ CartridgesAbbott recalls i-STAT EG7+, EG6+, G3+ cartridges over falsely high PCO2 and low pH results.
3 products
FDA•LOWPALAMIX duo / PALAMIX unoHeraeus recalls PALAMIX duo and uno mixing units due to risk of mixing rod loosening in units over 17 months old.
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•MODERATECustom Convenience Kits Pre Op Kit - NSWindstone Medical Packaging corrects Pre Op Kit - NS, Part AMS14433, due to IV backflow risk.
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 Healthcare Central Line Dressing KitLSL Healthcare recalls Central Line Dressing Kit 2717H due to non-sterile alcohol prep pads.
6 products
FDA•MODERATEArrow Echogenic Introducer NeedleArrow recalls Echogenic Introducer Needle over adhesive defect that may cause needlestick injury.
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 FunnelSurgiSmoke Solutions recalls Flamingo Funnels over sterilization drape nonconformance.
3 products