FDA•MODERATE
Medline ENFit G-Tube Connector
Medline recalls ENFit G-tube connectors in care/discharge kits over seal failure and leakage risk.
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Medical Devices Recalls
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FDA•MODERATESterile Radiology Procedure Kits Model DYNDH1491BMedline is recalling Sterile Radiology Procedure Kits Model DYNDH1491B due to potential sterile pouch packaging breach.
FDA•MODERATEStryker CHROMOPHARE Softlit Ring Surgical LightStryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System due to a potential ceiling cover support failure.
FDA•MODERATEParadise Ultrasound Renal Denervation CatheterReCor Medical is recalling the Paradise Ultrasound Renal Denervation Catheter (Model PRDS-068-02) as these units were intended to be scrapped.
3 products
FDA•MODERATEVue Motion V12 Imaging SystemPhilips Vue Motion V12 (1017979) may display image frames out of sequence during dynamic imaging runs.
FDA•MODERATEPuracol and Puracol Plus Collagen Wound DressingsMedline is recalling Puracol and Puracol Plus wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH A1c_E assay due to a risk of depressed results when used alongside the RCRP assay on the same analyzer.
- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo Ventilator
Philips Respironics recalls Trilogy Evo ventilators over tidal volume discrepancy with non-pneumatic nebulizers.
4 products 
FDA•MODERATEBD Alaris System with Guardrails Suite MXBD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.
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•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•CRITICALHandy Solutions Neck & Shoulders Heating PadHandy Solutions Neck & Shoulders Heating Pad (Model 25607) may overheat and cause burns if folded or placed under the body.
FDA•CRITICALErbe Flexible CryoprobeErbe USA recalls Flexible Cryoprobes because probes may rupture or burst during use.
4 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•LOWDatascope Cardiosave Battery Charging StationDatascope is recalling the Cardiosave battery charging station due to a screw defect in the left bay that prevents proper charging.
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•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.
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•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•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•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.