FDA•MODERATE
BD 10mL Non-Sterile Luer-Lok Syringe
BD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.
Filters
Category
Agency
Severity
Date
Distributed in
Medical Devices Recalls
Back to home ←
FDA•MODERATEIBA Proton Therapy System PROTEUS 235IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling the ShockPulse-SE Lithotripsy System generator due to a wiring issue that may cause treatment delays.
2 products
FDA•MODERATEMedline Nail KitMedline is recalling the Nail Kit (model DYKM1528) because the included sterile saline wound wash may not meet sterility requirements.
5 products
FDA•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 products- Device RecallFDA•MODERATEDatascope CS300 IABP
Datascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
2 products 
FDA•MODERATESTA Liatest Free Protein S KitDiagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.
- Device RecallFDA•MODERATEB. Braun 21G Winged Infusion Set
B. Braun recalls 21G winged infusion sets due to risk of dull or broken needle tip.
3 products 
FDA•MODERATEEVO+ Visian Toric Implantable Collamer Lens (TICL)Staar Surgical is recalling EVO+ Visian Toric ICL Model VTICM5 due to incorrect length labeling (12.1 mm labeled vs. 12.6 mm actual) causing excessive vault and potential angle closure.
FDA•MODERATEAesculap Minop TrocarAesculap is recalling the Minop Trocar 150mm because the shaft may be too long.
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
FDA•MODERATECobas Pro Integrated Solutions Analytical UnitsRoche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated test results.
2 products
FDA•MODERATEGE Healthcare Centricity Universal ViewerGE Healthcare is recalling Centricity Universal Viewer software due to a risk of patient information and image mismatch.
FDA•MODERATEOctopus Nuvo Tissue StabilizerMedtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATEAgiliti Adapt PumpAgiliti is recalling the Adapt Pump (model 61600200) for a software failure that prevents the Microclimate Management function from restarting.
FDA•MODERATEMedline Apheresis and Dialysis KitsMedline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.
6 products
FDA•MODERATEEncore Medical Knee and Shoulder ImplantsEncore Medical is recalling EMPOWR 3D Knee and RSP Humeral Socket implants due to incorrect labeling.
3 products
FDA•MODERATEPIE PAK Trolley SystemEdermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
FDA•MODERATEHitachi Proton Beam Therapy SystemHitachi recalls Proton Beam Therapy System over patient positioning software anomaly.
2 products
FDA•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
FDA•MODERATELaerdal Compact Suction Unit 4 RTCALaerdal is recalling LCSU 4 RTCA suction units due to potential electromagnetic noise levels exceeding regulatory limits.
FDA•MODERATEMedline Surgical and Biopsy Convenience KitsMedline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.
62 products
FDA•MODERATEAuris Health MONARCH Platform Bronchoscopy SystemAuris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.
FDA•MODERATEMOLLI 2 Surgical Marker SystemStryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
FDA•MODERATEMediHoney Gel DressingIntegra LifeSciences is recalling MediHoney Gel dressing models 31805 and 31815 due to a potential breach in the sterile packaging barrier.
3 products
FDA•MODERATESpectrum IQ Infusion PumpBaxter is recalling Spectrum IQ Infusion Pumps (Model 3570009) due to incomplete testing of occlusion alarm functionality.
- Device RecallFDA•MODERATEPhilips Azurion 5 M20 and 7 M12 Systems
Philips recalls Azurion 5 M20 and 7 M12 systems over risk of unexpected table movement when Reset Geometry is pressed.
8 products 
FDA•MODERATEAlphatec Spine Lateral Navigation Disc Prep InstrumentsAlphatec Spine is recalling 10mm Osteotome navigation instruments due to a design flaw in the array connection geometry.
2 products
FDA•MODERATEHalyard Transport Bag Kit LIFE0080-01Halyard Transport Bag Kit LIFE0080-01 recalled due to Tyvek bag seal issue that may compromise sterility.
FDA•LOWStraumann WB Impression Post Closed TrayStraumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.
FDA•CRITICALTRUE METRIX Blood Glucose Meter InstructionsTrividia recalls TRUE METRIX meter instructions over inadequate E-5 error guidance.
7 products
FDA•MODERATEPhilips Brilliance iCT Gantry Rotor FastenersPhilips is recalling Brilliance iCT systems due to a risk of rotor parts becoming unsecured and potentially expelled during gantry rotation.
4 products
FDA•MODERATEOlympus Single Use 3-Lumen Sphincterotome VOlympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a risk of deformation and performance loss.
30 products
FDA•MODERATEMaquet Venous Bubble SensorMaquet is recalling the Venous Bubble Sensor (Model 701055720) due to cable durability issues that may cause device errors.
FDA•MODERATEFDR Visionary Suite X-ray GeneratorFUJIFILM is recalling FDR Visionary Suite X-ray generators due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
FDA•MODERATEVITEK 2 Gram-negative Susceptibility CardsBiomerieux is recalling 30+ VITEK 2 susceptibility cards due to potential quality control failures and false resistant test results.
2 products
FDA•MODERATEPrismaflex M100 SetVantive is recalling the Prismaflex M100 Set due to a potential dislodgement of the deaeration chamber from the control unit.
8 products
FDA•MODERATEEncore Medical EMPOWR Acetabular and Knee InsertsEncore Medical is recalling EMPOWR acetabular liners and knee inserts due to a packaging discrepancy that may cause surgical delays.
2 products- Device RecallFDA•Olympus ViziShot 2 FLEX (19G) EBUS-TBNA Needles
Olympus expands recall of all ViziShot 2 FLEX (19G) EBUS-TBNA needles due to component detachment risk, including one death.