FDA•MODERATE
Imactis CT-Navigation System
GE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.
Filters
Category
Agency
Severity
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•MODERATEB. Braun Winged Infusion SetsB. Braun is recalling 21GA Winged Infusion Sets (Model 7M2802) due to the risk of needle tips being dull, blunt, or breaking during use.
3 products
FDA•MODERATEMICS3 Angled Sagittal Saw AttachmentHowmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because external screws may loosen and detach during use.
FDA•MODERATEOn-X Mitral Heart Valve with Conform-X Sewing RingOn-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.
FDA•MODERATEBeckman Coulter Chemistry AnalyzersBeckman Coulter is recalling chemistry analyzers due to a software error that may cause system delays and impact patient diagnosis.
2 products
FDA•MODERATEMedline Cardiac Procedure KitsMedline is recalling cardiac procedure kits to clarify that the included chest drainage units are intended for adult patients only.
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G insulin pumps (software 6.60-6.62) due to software defects that may cause inaccurate insulin delivery.
- Device RecallFDA•MODERATECentricity Universal Viewer Software
GE is recalling Centricity Universal Viewer software versions 5.0 and 7.0 due to a cybersecurity vulnerability that may expose user credentials.
4 products - Device RecallFDA•MODERATEHealthCast Vital Sync Remote Patient Monitoring System
Covidien is recalling Vital Sync software because bedside monitor alarms may fail to transmit to the remote monitoring system.
2 products 
FDA•MODERATETandem Insulin Infusion PumpTandem is recalling insulin infusion pumps in Czech Republic and Slovakia due to user guide translation errors that could cause unintended insulin delivery.
FDA•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the risk of rubber fragments detaching during use.
2 products
FDA•MODERATEParadise Ultrasound Renal Denervation System CatheterReCor Medical is recalling Paradise Ultrasound Renal Denervation System catheters that were intended to be scrapped and are not for use.
3 products- Device RecallFDA•MODERATEB. Braun Cesk Northside Anesthesia Tray
B. Braun is recalling the Cesk Northside Anesthesia Tray (Model 555076) due to potential cracking of the included adhesive tubing.
8 products 
FDA•MODERATEJiffy Original Composite Polisher Cups (Coarse)Ultradent is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011, due to crumbling and breakage risk.
FDA•MODERATEMedline Medcrest Surgical GownsMedline is recalling Medcrest surgical gowns due to fabric delamination risks that may lead to infection or delays in patient care.
3 products
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed is recalling the Impella RP Flex with SmartAssist due to a potential dP sensor malfunction that may cause inaccurate readings.
3 products
FDA•MODERATEBD 10mL Non-Sterile Luer-Lok SyringeBD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.
FDA•MODERATELutronic CLARITY II Laser SystemLutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemPhilips is recalling Azurion 3 and 7 M12 systems over a software defect that can cause unexpected patient table movement.
8 products
FDA•MODERATEI.T.S. Headless Compression Screw SystemI.T.S. is recalling the Headless Compression Screw System due to higher-than-expected temperature increases during MRI procedures.
24 products
FDA•MODERATEDatascope CS300 IABPDatascope is updating the IFU for CS300 IABP software version C.01 to correct battery runtime and cycle specifications.
2 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•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•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that may prevent proper therapy delivery.
2 products
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•MODERATEAdapt Pump Model 61600200Agiliti is recalling Adapt Pump Model 61600200 due to Microclimate Management function failure after Autofirm use.
FDA•MODERATEGEM Premier 5000 PAKInstrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause cartridge ejection and delayed results.
20 products
FDA•MODERATECobas Pro Integrated Solutions Analytical UnitsRoche is recalling cobas pro analytical units due to a software defect causing erroneous, repeated lab results for specific Spline-type assays.
2 products
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
- Device RecallFDA•Olympus ViziShot 2 FLEX EBUS-TBNA Needles
Olympus is recalling ViziShot 2 FLEX (19G) EBUS-TBNA needles due to a device safety defect.
FDA•MODERATEMediHoney Gel DressingIntegra LifeSciences is recalling MediHoney Gel dressing (catalog numbers 31805 and 31815) due to a potential sterile barrier breach.
3 products
FDA•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the High Flow Insufflation Unit, Model UHI-3, due to a software issue that may cause overpressure events.
3 products
FDA•MODERATEGE Healthcare Centricity Universal Viewer Zero Footprint ClientGE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client (Models 2110344-039, -046, -047) due to patient information and image mismatch risk.
FDA•MODERATEReverse Shoulder Prosthesis Humeral Socket InsertEncore Medical is recalling the Reverse Shoulder Prosthesis Humeral Socket Insert (model 509-00-432) due to incorrect labeling.
3 products
FDA•MODERATEAesculap Minop TrocarAesculap is recalling the Minop Trocar 150mm (Model FF399R) due to a potential defect where the trocar shaft length may be too long.
FDA•MODERATEMedline Unna-Z Stretch Zinc Paste BandageMedline is recalling Unna-Z Stretch Zinc Paste Bandages due to a labeling error that omits castor oil and calamine from the ingredient list.
FDA•MODERATEPIE PAK Trolley SystemEdermy is recalling PIE PAK trolley system models P2HC-A, P2HC-S, and P2HC due to a lack of required 510(k) clearance.
2 products
FDA•MODERATEOctopus Nuvo Tissue StabilizerMedtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.
FDA•MODERATELaerdal Compact Suction Unit 4 RTCALaerdal is recalling Compact Suction Unit 4 RTCA models due to potential electromagnetic noise interference exceeding safety standards.
FDA•MODERATESpectrum IQ Infusion PumpBaxter is recalling Spectrum IQ Infusion Pumps (Model 3570009) because they were released without full occlusion alarm testing.
FDA•MODERATEEndo-Model Knee Replacement PlateauWaldemar Link is recalling the Endo-Model Replacement Plateau due to a risk of longitudinal fracture that may cause bushing detachment.
13 products
FDA•MODERATEAPTUS 2.5 TriLock Screw 16mmMedartis is recalling APTUS 2.5 TriLock Screw 16mm (Model A-5750.16/1) due to a packaging mix-up with 2.8mm screws.
2 products
FDA•MODERATEMaquet Venous Bubble SensorMaquet is recalling Venous Bubble Sensors for 3/8" x 3/32" tubing due to cable durability issues that may cause sensor failure.
FDA•MODERATEFDR Visionary Suite X-ray GeneratorFDR Visionary Suite X-ray generators are being recalled due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATEMedline Dialysis Insertion KitsMedline is recalling dialysis insertion kits due to defective Tego Connector silicone seals that may cause leakage or therapy interruption.
6 products
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling ShockPulse-SE Lithotripsy System generators due to a mis-wired component that may cause treatment delays.
2 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 manufacturing defect that may cause device deformation.
30 products
FDA•MODERATEMedline Surgical Convenience KitsMedline is recalling various surgical convenience kits due to potential issues with sterilization and packaging calibration.
62 products