FDA•MODERATE
Medline Micro-Kill Bleach Germicidal Wipes
Medline Micro-Kill Bleach Germicidal Wipes may lose disinfecting strength before their 12-month shelf life ends.
4 productsFilters
Category
Agency
Severity
Date
Distributed in
Medical Devices Recalls
Back to home ←
FDA•MODERATEV-Loc 90 Absorbable Wuture Closure DeviceCovidien recalls V-Loc 90 wound closure devices over possible sterile barrier tears that may cause infection or prolonged surgery.
7 products
FDA•MODERATEBoston Scientific Enhance Transcarotid/Peripheral Access KitBoston Scientific recalls Enhance Transcarotid/Peripheral Access Kits over detachable depth markings.
FDA•MODERATESpacelabs Xhibit Central Station DisplayPort SplitterSpacelabs recalls Xhibit Central Station over DisplayPort splitter audio/video failures.
2 products
FDA•MODERATEGORE VIABIL Biliary EndoprosthesisGORE VIABIL biliary endoprosthesis recalled due to mislabeling of size and drainage holes.
2 products- Device RecallFDA•MODERATEnavify Digital Pathology Software
Ventana recalls navify Digital Pathology v2.5 over image/metadata discrepancy in the Viewer window.
FDA•MODERATEBOBBY Balloon Guide CatheterMicroVention recalls BOBBY Balloon Guide Catheters due to increased balloon pinhole defects.
FDA•MODERATENeuroguard IEP Carotid Stent SystemContego Medical recalls Neuroguard IEP carotid stent system over filter opening failure risk.
FDA•MODERATECOAPTIUM ConnectTISSIUM recalls COAPTIUM Connect nerve repair device over unsubstantiated 36-month shelf life.
8 products
FDA•MODERATEBlom-Singer Classic Indwelling Voice ProsthesisBlom-Singer Classic Voice Prosthesis recalled due to incorrect labeling of flange types.
2 products
FDA•MODERATEGEM Premier 7000 with iQM3Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 due to lysing bag solution concentration issue.
2 products
FDA•MODERATEU2 Total Knee System Femoral Offset BushingU2 Total Knee System femoral offset bushing recalled due to incorrect engraved numbering that may cause misorientation.
2 products
FDA•MODERATEMedline Hudson RCI Heated Breathing CircuitMedline recalls Hudson RCI heated breathing circuits for infants due to connector thermal damage risk.
5 products
FDA•MODERATEAtellica CH Urine Albumin AssaySiemens recalls Atellica CH Urine Albumin assay over falsely depressed UN_c and A1c_E results and QC failures.
2 products
FDA•MODERATEMicroScan LabPro UpdateBeckman Coulter is recalling MicroScan LabPro Update Panel Update Software Update, MicroScan LabPro Update Panel 11 (US), due to potential incorrect antibiotic resistance results that may lead to delayed or inappropriate treatment.
2 products
FDA•MODERATE5-PLASMA Bivalirudin AMR Verification KitAniara recalls 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) due to stability issues causing degradation of bivalirudin.
3 products
FDA•MODERATEPhilips Allura Xper Interventional Fluoroscopic X-Ray SystemsPhilips recalls Allura Xper X-ray systems over unauthorized HDDs causing loss of imaging, movement, or data.
5 products
FDA•MODERATEHardyDisk Cefiderocol 30µg Susceptibility DisksHardy Diagnostics recalls HardyDisk Cefiderocol 30µg disks due to incorrect cartridges that may cause false susceptibility results.
FDA•MODERATEU2 Total Knee System PSA Box TrialUnited Orthopedic recalls U2 Total Knee PSA Box Trials (models 9323-5511 thru 9323-5526) due to screw defect.
4 products
FDA•MODERATEGE Portrait Core Services Software V1.2.0GE recalls Portrait Core Services SW V1.2.0 over a security vulnerability.
2 products
FDA•MODERATEFilmArray NGDS Warrior PanelBiofire Defense recalls FilmArray NGDS Warrior Panel due to strain mismatches affecting test accuracy.
FDA•MODERATEGE MAC VU360 ElectrocardiographGE recalls MAC VU360 ECG over software issue that may mix patient data.
FDA•MODERATEMerge PACS Medical Imaging WorkstationMerge PACS workstation recalled over risk of displaying thumbnails from a prior patient study.
2 products
FDA•LOWSyva Emit Tox Tricyclic Antidepressant Calibrator/ControlsSiemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
FDA•LOWSyva Emit Disopyramide AssaySiemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.
FDA•MODERATEMaquet Flow Anesthesia Machine VaporizerMaquet recalls Flow anesthesia machines over risk of insufficient anesthesia.
FDA•MODERATEStryker AHTO Tube Set PackagingStryker recalls AHTO Tube Set Packaging (Cat. 0250070600) over handpiece leaking.
5 products
FDA•MODERATEDialysis Change Tray Clear SequenceMedical Action recalls Dialysis Change Tray Clear Sequence (Model 78791) due to improper seal in needle-free access device.
FDA•MODERATEOXOS MC2 Portable X-Ray SystemOXOS Medical recalls MC2 Portable X-Ray System due to overheating circuit board.
2 products
FDA•MODERATEVector Pedicle Screw System Anti-TorqueInnovasis recalls Vector Pedicle Screw System anti-torque instrument (LS-749) due to undersized tip that may prevent engagement during surgery.
FDA•CRITICALHalyard Cardiac Cath Pack with Medline ManifoldAVID Medical recalls Halyard kits with Medline manifolds due to particulate risk.
3 products
FDA•MODERATEmunevo DRIVE Powered Wheelchair Control SystemMunevo recalls wheelchair control systems over software calibration issue causing steering drift and collision risk.
- Device RecallFDA•MODERATEWASPLab WebApp Software
Copan WASP recalls WASPLab WebApp software over a result-overwrite issue.
FDA•MODERATERadial Jaw 4 Biopsy ForcepsBoston Scientific recalls Radial Jaw 4 biopsy forceps due to sterile barrier breach risk.
4 products
FDA•MODERATEFORWARD Oral Airway KitIntegrated Medcraft recalls FORWARD Oral Airway Kits due to possible occluded airway tip.
2 products- Device RecallFDA•MODERATEQuantum 4Front 2 Wheelchair Controller
Quantum Rehab recalls the Quantum 4Front 2 wheelchair controller over a software issue that can cause unexpected park brake stops.
13 products 
FDA•MODERATETherabody Theragun G4 PRO ChargerTherabody recalls Theragun G4 PRO charger due to fire risk from overheating cradle.
FDA•CRITICALBD Needle Kit for Powered DriverBard Access recalls BD Powered Driver Needle Kits over obturator removal difficulty.
FDA•MODERATEPower Over Fiber Base ModuleTerex Utilities recalls Power Over Fiber Base Module due to missing laser certification and improper labeling.
FDA•MODERATEStryker Hoffmann II Connecting Rod Micro 3 x 30mmStryker recalls Hoffmann II Connecting Rod Micro 3 x 30mm due to potential cracking after cleaning and sterilization.
7 products
FDA•MODERATEGEM Premier 5000/7000 Bar Code Reader WandInstrumentation Laboratory recalls BCR Wand for GEM Premier 5000/7000 analyzers; may assign results to wrong patient ID.
10 products
FDA•MODERATEOsteoBallast 45 x 17.5 mmIsoTis recalls OsteoBallast 45 x 17.5 mm DBM mesh due to underfill, risking incomplete fusion.
FDA•CRITICALResmed Astral 100/150 VentilatorResMed recalls Astral 100/150 ventilators due to supercapacitor leakage that may interrupt ventilation.
FDA•MODERATEPhilips Brilliance CT ScannersPhilips recalls Brilliance CT scanners over possible scan trigger failure, risking patient rescan and extra radiation.
3 products
FDA•MODERATEAMS Spinal KitAMS SPINAL KIT recalled due to supplier quality issues with included Lidocaine HCl injection.
9 products
FDA•MODERATEMedtronic EOPA Arterial Cannula 22FRMedtronic recalls EOPA 22FR arterial cannula (Model 77422) over pinhole leak risk during bypass.
6 products
FDA•MODERATEArgon L-Cath PICC CathetersArgon recalls L-Cath PICC catheters over hub leak/crack risk.
2 products
FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls AMS medical convenience kits due to potential endotoxin variability in included sponges.
6 products
FDA•MODERATEMedline Pediatric Open Heart KitMedline is recalling convenience kits containing BD PurPrep 26 mL over possible Bacillus contamination.
4 products
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters (sizes 16, 18, 20) due to surface raw material risk.
9 products