FDA•MODERATE
Presource Kits
Cardinal Health is recalling multiple Presource procedural kits due to possible endotoxin contamination.
13 productsFilters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•MODERATEBD Intravascular Administration and Extension SetsBD recalls IV administration and extension sets due to possible sterilization failure.
2 products
FDA•MODERATEMarketside Tomato Bisque Soup KitMarketside Tomato Bisque Soup Kit recalled due to possible Listeria contamination.
FDA•MODERATEApheresis Red Blood Cells, Leukocytes ReducedLifeShare Blood Centers recalls apheresis red blood cells, leukocytes reduced, from a donor with incomplete eligibility screening.
FDA•MODERATERed Blood Cells, Leukocytes ReducedLifeShare distributed leukoreduced red blood cells from a malaria-endemic-area donor.
FDA•MODERATEERBECRYO 2 Cryosurgical UnitErbe USA recalls ERBECRYO 2 Cryosurgical Unit (Model 10402-000) over risk of cryoprobe rupture from CO2 leak.
FDA•MODERATEProNephro AKI (NGAL) Reagent KitBioporto recalls ProNephro AKI (NGAL) Reagent Kit over non-validated rework that could cause missed renal disease diagnosis.
FDA•MODERATEBIOFIRE Respiratory Panel 2.1BioFire recalls BIOFIRE Respiratory Panel 2.1 over increased false negatives.
FDA•MODERATESchwarzkopf Professional Osis Grip MousseHenkel recalls Schwarzkopf Osis Grip Mousse 6.76 oz cans over explosion risk from packaging leak.
FDA•MODERATEStraumann Bone Level Tapered ImplantStraumann recalls BLT Implant D 4.1mm RC SLActive 14mm due to possible 12mm length mismatch.
FDA•MODERATEEndo-Model Tibial Plateau Replacement SetWaldemar Link recalls Endo-Model tibial plateau replacement sets that may contain the wrong hinge component.
FDA•MODERATEClindamycin Palmitate Hydrochloride Oral SolutionAvet recalls Clindamycin Palmitate Oral Solution 75 mg/5 mL over particles and white flakes.
FDA•MODERATEER-Spec Vaginal SpeculumOBP Medical recalls ER-Spec X-Small vaginal speculums over a sharp-edge burr risk.
- Device RecallFDA•MODERATEPhilips Azurion Interventional X-Ray System
Philips recalls Azurion x-ray systems over software issues that may delay therapy or cause complications.
- Device RecallFDA•MODERATEPhilips Azurion Interventional Fluoroscopic X-Ray System
Philips recalls Azurion X-ray systems over software issues that may cause image degradation or loss of geometry movements.
- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Hoxworth Blood Center recalls Red Blood Cells, Leukocytes Reduced over malaria risk.
FDA•MODERATEGM Helix Dental ImplantStraumann recalls GM Helix dental implants over a packaging label mismatch that could cause bone compression.
FDA•MODERATEPhilips Allura Xper FDPhilips recalls Allura Xper FD x-ray systems over firmware issue causing loss of geometry movements.
FDA•MODERATEGlidesheath Slender A-KitTerumo recalls Glidesheath Slender A-Kit 6F 10cm .021GW (60-1060) due to wrong guidewire.
FDA•MODERATEDiovan (valsartan) 160 mg TabletsNovartis recalls Diovan (valsartan) 160 mg tablets due to failed dissolution specs.
FDA•MODERATELyle Style: 2 Made In The Columbia River Gorge WashingtonsUndeclared soy allergen in Lyle Style Bloody Mary Mix.
2 products
FDA•MODERATEVodka Tomato Sauce 24 ozSHEANDRO recalls Vodka Tomato Sauce 24 oz jars for undeclared milk allergen.
FDA•MODERATESemaglutide 12.5mg Multi-Dose VialApollo Care recalls semaglutide 12.5mg vials due to particulate matter.
11 products
FDA•MODERATENeisseria meningitidis Gp C 2ml/VLRemel recalls Neisseria meningitidis Gp C 2ml/VL (R30166901) for failing to test positive within 60 seconds.
FDA•MODERATEMedline Micro-Kill Bleach Germicidal WipesMedline Micro-Kill Bleach Germicidal Wipes may lose disinfecting strength before their 12-month shelf life ends.
4 products
FDA•MODERATEApheresis Platelets, Leukocytes ReducedSuncoast Blood Bank recalls apheresis platelets from a donor with recent malaria-area travel.
FDA•MODERATEV-Loc 90 Absorbable Wuture Closure DeviceCovidien recalls V-Loc 90 wound closure devices over possible sterile barrier tears that may cause infection or prolonged surgery.
7 products
FDA•MODERATEBoston Scientific Enhance Transcarotid/Peripheral Access KitBoston Scientific recalls Enhance Transcarotid/Peripheral Access Kits over detachable depth markings.
FDA•MODERATESpacelabs Xhibit Central Station DisplayPort SplitterSpacelabs recalls Xhibit Central Station over DisplayPort splitter audio/video failures.
2 products
FDA•MODERATEGORE VIABIL Biliary EndoprosthesisGORE VIABIL biliary endoprosthesis recalled due to mislabeling of size and drainage holes.
2 products- Device RecallFDA•MODERATEnavify Digital Pathology Software
Ventana recalls navify Digital Pathology v2.5 over image/metadata discrepancy in the Viewer window.
FDA•MODERATEBOBBY Balloon Guide CatheterMicroVention recalls BOBBY Balloon Guide Catheters due to increased balloon pinhole defects.
FDA•MODERATEMirabegron Extended-Release Tablets 25 mgZydus recalls Mirabegron ER 25 mg tablets over nitrosamine impurity.
FDA•MODERATEOribe Serene Scalp Densifying ShampooOribe Serene Scalp Densifying Shampoo recalled over microbial contamination.
FDA•MODERATENeuroguard IEP Carotid Stent SystemContego Medical recalls Neuroguard IEP carotid stent system over filter opening failure risk.
FDA•MODERATECOAPTIUM ConnectTISSIUM recalls COAPTIUM Connect nerve repair device over unsubstantiated 36-month shelf life.
8 products
FDA•MODERATEBlom-Singer Classic Indwelling Voice ProsthesisBlom-Singer Classic Voice Prosthesis recalled due to incorrect labeling of flange types.
2 products
FDA•MODERATEGEM Premier 7000 with iQM3Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 due to lysing bag solution concentration issue.
2 products
FDA•MODERATEU2 Total Knee System Femoral Offset BushingU2 Total Knee System femoral offset bushing recalled due to incorrect engraved numbering that may cause misorientation.
2 products
FDA•MODERATEMedline Hudson RCI Heated Breathing CircuitMedline recalls Hudson RCI heated breathing circuits for infants due to connector thermal damage risk.
5 products- FDA•MODERATERed Blood Cells, Leukocytes Reduced
Rhode Island Blood Center recalls Red Blood Cells, Leukocytes Reduced units from a malaria-endemic-area donor.
FDA•MODERATEAtellica CH Urine Albumin AssaySiemens recalls Atellica CH Urine Albumin assay over falsely depressed UN_c and A1c_E results and QC failures.
2 products
FDA•MODERATEWangshin Doenjang Soybean PasteWangshin Doenjang soybean paste recalled over undeclared anchovy (fish) allergen.
FDA•MODERATEMicroScan LabPro UpdateBeckman Coulter is recalling MicroScan LabPro Update Panel Update Software Update, MicroScan LabPro Update Panel 11 (US), due to potential incorrect antibiotic resistance results that may lead to delayed or inappropriate treatment.
2 products
FDA•MODERATE5-PLASMA Bivalirudin AMR Verification KitAniara recalls 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) due to stability issues causing degradation of bivalirudin.
3 products- FDA•MODERATEPhilips Allura Xper Interventional Fluoroscopic X-Ray Systems
Philips recalls Allura Xper X-ray systems over unauthorized HDDs causing loss of imaging, movement, or data.
5 products 
FDA•MODERATEHardyDisk Cefiderocol 30µg Susceptibility DisksHardy Diagnostics recalls HardyDisk Cefiderocol 30µg disks due to incorrect cartridges that may cause false susceptibility results.
FDA•MODERATEU2 Total Knee System PSA Box TrialUnited Orthopedic recalls U2 Total Knee PSA Box Trials (models 9323-5511 thru 9323-5526) due to screw defect.
4 products
FDA•MODERATEBig Way Hot Pot Miso PasteBig Way Hot Pot Miso Paste recalled for undeclared milk allergen.
FDA•MODERATEDicyclomine Hydrochloride Capsules 10mgAurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.