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BD Alaris System with Guardrails Suite MX
BD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.
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Medical Devices Recalls
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FDA•MODERATEOlympus PKS Cutting ForcepsOlympus recalls PKS Cutting Forceps over jaw breakage risk from defective welds.
7 products
FDA•MODERATEMICS3 Angled Sagittal Saw AttachmentHowmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment due to a risk of external screws loosening and detaching during use.
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•MODERATELantern Knee System Drill PlateThe Lantern Knee System drill plate is recalled due to a manufacturing error that may cause excessive bone cuts during surgery.
2 products
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G insulin pumps (models MMT-1884, MMT-1886) over software defects that may cause inaccurate insulin delivery.
FDA•MODERATEStraumann Custom Abutment TiStraumann recalls Custom Abutment Ti for Straumann RC due to material mix-up.
2 products
FDA•MODERATETECNIS Eyhance IOL with Simplicity Delivery SystemAMO is recalling TECNIS Eyhance IOLs with Simplicity Delivery System (model DIB00) because the lens may fail to unfold properly.
2 products
FDA•MODERATEBiDop 3 Pocket DopplerKoven Technology is recalling the BiDop 3 Pocket Doppler due to unauthorized fetal indication labeling.
2 products
FDA•MODERATEI.T.S. Headless Compression Screw SystemI.T.S. is recalling Headless Compression Screw System components due to updated MRI safety testing showing higher temperature risks.
24 products
FDA•MODERATEOlympus Endoscope Air/Water and Suction ValvesOlympus recalls endoscope valves MAJ-1444 and MAJ-1443 over reprocessor incompatibility.
4 products
FDA•MODERATEImactis CT-Navigation SystemGE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.
FDA•MODERATELeksell Gamma Knife Radiosurgery SystemElekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit systems due to potential adapter misalignment during radiation delivery.
FDA•MODERATEArtegraft Vascular GraftLeMaitre Vascular is recalling the Artegraft Vascular Graft due to a labeling mix-up on the outer packaging.
FDA•MODERATEConvatec EsteemBody Drainable PouchConvaTec recalls EsteemBody drainable pouches over possible leakage from a manufacturing issue.
3 products
FDA•MODERATEAptima HPV AssayHologic is recalling the Aptima HPV Assay due to the potential for the test to generate invalid or false negative results.
FDA•MODERATECub Pediatric Crib Model FL19HStryker is recalling Cub Pediatric Crib Model FL19H over missing access door warning labels.
FDA•MODERATESTA Liatest D-Di Assay KitDiagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate test results.
2 products
FDA•MODERATEWelch Allyn Spot Vision Screener VS100Welch Allyn is recalling the Spot Vision Screener VS100 (software v3.2.0.1) due to a screen flickering issue that may trigger seizures.
- Device RecallFDA•MODERATECentricity Universal Viewer Software
GE recalls Centricity Universal Viewer software over credential exposure risk.
4 products 
FDA•MODERATEID NOW Influenza A & B 2 Test KitAbbott is recalling ID NOW Influenza A & B 2 test kits (Model 427-000) due to an increased rate of invalid results.
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•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•MODERATELutronic CLARITY II Laser SystemLutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.
FDA•MODERATEArtelon FlexBand Dynamic MatrixArtelon FlexBand Dynamic Matrix recalled over failed endotoxin testing.
3 products
FDA•MODERATEBeckman Coulter DxC 700 AU Chemistry AnalyzerBeckman Coulter recalls DxC 700 AU and AU5800 analyzers over software delay risk.
2 products- Device RecallFDA•MODERATEHealthCast Vital Sync Remote Patient Monitoring System
HealthCast is recalling Vital Sync software due to a failure to transmit or receive critical patient bedside monitor alarms.
2 products 
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to compromised seals on the included antiseptic swabsticks.
FDA•MODERATEEndo-Model Replacement PlateauEndo-Model Replacement Plateau is recalled due to a risk of bushing detachment from the screw shaft caused by longitudinal fractures.
13 products
FDA•MODERATEGEM Premier 5000 PAKInstrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause ejection and delay patient results.
20 products
FDA•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that could impact therapy delivery.
2 products
FDA•MODERATEAPTUS 2.5 TriLock ScrewsMedartis is recalling APTUS 2.5 TriLock Screws (model A-5750.16/1) due to a mix-up with 2.8mm screws.
2 products
FDA•MODERATEEquinoxe Core Instrument KitExactech recalls Equinoxe Core Instrument Kit and Ergo Impactor Handle over missing cross-pin risk.
2 products
FDA•MODERATERaz Mobile Shower Commode ChairsRaz Design is recalling various mobile shower commode chairs due to a seat bracket issue that may pose a fall risk to users.
2 products
FDA•MODERATEMedline Unna-Z Stretch Zinc Paste BandageMedline is recalling Unna-Z Stretch Zinc Paste Bandages due to an incomplete ingredient list on the label.
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•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•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.