FDA•MODERATE
HydroMARK Breast Biopsy Site Marker
Devicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.
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Medical Devices Recalls
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FDA•CRITICALOmnipod 5 PodsInsulet recalls Omnipod 5 Pods over cannula damage causing insulin leaks and under-delivery, risking DKA.
3 products
FDA•MODERATEHalyard Purezero Ultraviolet Nitrile Exam GlovesHalyard is recalling Purezero Ultraviolet Nitrile Exam Gloves due to a failure to meet chemical permeation performance specifications.
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemsPhilips is recalling various Azurion systems due to potential mechanical wear in the Float Tabletop control module affecting table movement.
2 products
FDA•MODERATEPhilips Azurion X-ray Tube Cooling Unit Deaeration HosePhilips recalls Azurion systems: deaeration hose may leak oil, causing cooling failure and low-dose fluoroscopy lockout.
4 products
FDA•MODERATEGlobus Medical OneLIF Integrated FixationGlobus Medical is recalling OneLIF integrated fixation systems because some units may not meet shelf-life specifications, which could affect product performance.
2 products
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic recalls GUNDRY Retrograde Cannula over sterile barrier breach risk.
9 products
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.
FDA•MODERATESwan-Ganz Catheters (Multiple Models)Becton, Dickinson and Company is recalling multiple variants of its Swan-Ganz pulmonary artery catheters due to a potential risk of valve leakage that may affect the balloon inflation performance.
3 products
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
FDA•CRITICALOmnicell i.v.STATION Syringe LabelsOmnicell is recalling sterile syringe label stock for the i.v.STATION device due to a risk of mislabeled IV medication syringes.
FDA•MODERATEBARD Dynamic Deca Steerable CatheterBARD Dynamic Deca Steerable EP catheter recalled due to incomplete seals on sterile product.
26 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
FDA•MODERATEQuickVue Dipstick Strep A TestQuidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
FDA•MODERATEThermedx FluidSmart Urology Tube SetStryker is recalling the FluidSmart Urology Tube Set (REF LL0006) due to the distribution of nonconforming products.
FDA•MODERATESelenia Dimensions Mammography SystemsHologic recalls Selenia Dimensions mammography systems over loose or broken internal bolts.
2 products
FDA•MODERATEDexcom G7 CGM iOS AppDexcom recalls G7 CGM iOS App (v2.9.0–2.11.2) over glucose alert delays that may cause missed hypo/hyperglycemic events.
4 products
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
FDA•MODERATELUCAS Chest Compression SystemJolife AB is recalling LUCAS 2, 3, and 3.1 chest compression systems due to missing service documentation.
2 products
FDA•MODERATERevolution Ascend CTGE HealthCare recalls Revolution Ascend CT over AW Server security vulnerability.
7 products
FDA•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
14 products
FDA•MODERATEDonJoy IceMan Classic CubeDonJoy IceMan Classic Cube recalled due to broken connector interrupting cold therapy.
4 products
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) for out-of-spec.
2 products
FDA•MODERATEMedline Convenience KitsMedline is recalling Ancillary Pack-LF and Open Heart Anesthesia ICC-A kits due to potential issues with sterilization and packaging calibration.
58 products
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.
FDA•MODERATEOne Step 10A in vitro diagnostic testOne Step 10A in vitro diagnostic test recalled for lack of FDA clearance.
7 products
FDA•MODERATEBiofire Spotfire Respiratory/Sore Throat PanelBioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
FDA•MODERATEDEX Ophthalmic Tissue ForcepsKatalyst Surgical recalls DEX Ophthalmic Tissue Forceps, model DVF4005-23, due to IFU corrective action.
12 products
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.
FDA•MODERATESpacelabs Ultraview SL Command ModuleSpacelabs is recalling the Ultraview SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
FDA•MODERATEProdisc C SK Cervical Disc ImplantCentinel Spine recalls Prodisc C SK cervical disc implants due to labeling mix-up (5mm/6mm).
2 products
FDA•CRITICALCook Centimeter Sizing CatheterCook recalls Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20) over marker band cracking risk.
3 products
FDA•MODERATEBoston Scientific LUX-DX II Arrhythmia DetectorBoston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
2 products
FDA•MODERATEERBEFLO CleverCap CO2 Tubing/Cap SetsErbe Medical recalls ERBEFLO CleverCap CO2 tubing/cap sets due to risk of water aspiration and respiratory failure.
3 products- Device RecallFDA•MODERATEda Vinci Surgical System Universal Surgical Manipulator
Intuitive Surgical is recalling the USM arm sub-assembly for da Vinci X and Xi systems due to a risk of internal screw breakage.
2 products 
FDA•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive is recalling SureForm 30 Gray stapler reloads due to the risk of an incomplete staple line during surgical procedures.
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline recalls kits with Webcol Alcohol Prep Pads due to possible non-sterility and contamination risk.
10 products
FDA•MODERATEImmy Myco DDR Trident Neutralization Buffer BImmuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.
FDA•MODERATEATTUNE Revision Hinge FemoralDepuy Synthes recalls ATTUNE Revision Hinge Femoral over packaging adhesion that may compromise sterility.
9 products
FDA•MODERATEepoc BGEM BUN Test CardSiemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.
FDA•MODERATEStraumann n!ce PMMA Full-arch RestorationStraumann recalls n!ce PMMA Full-arch Restoration due to incorrect screw seat interface.
2 products
FDA•MODERATEBD GasPak EZ CO2 Pouch SystemBD recalls GasPak EZ CO2 and Campy pouch systems over low CO2 output.
2 products
FDA•MODERATEPhilips Bridge Prep KitMerit Medical recalls Philips Bridge Prep Kit (REF K12-09098B) over catheter resistance on guidewire.
4 products
FDA•MODERATEi-STAT EG7+ CartridgeAbbott recalls i-STAT EG7+ cartridges (03P76-25) over inaccurate PCO2/pH results.
3 products