FDA•MODERATE
OverStitch Suture Cinch
Boston Scientific recalls OverStitch Suture Cinch over deployment and suture-cutting failures.
2 productsFilters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•MODERATEProspector Popcorn: 4 productsProspector Popcorn recalls gourmet popcorn varieties over inaccurate nutrient declarations.
4 products
FDA•MODERATETD Navio Midi Speech Generating DeviceTobii Dynavox recalls TD Navio Midi speech device over battery tab damage risk.
2 products
FDA•MODERATEArrow-LOK ImplantArrowhead recalls Arrow-LOK Implants over missing gamma radiation audit, risking infection.
2 products
FDA•MODERATEPhilips Cardiac Workstation 5000Philips recalls Cardiac Workstation 5000 over intermittent inaccurate heart-rate data.
2 products
FDA•MODERATEDentsply Sirona Capsule MixerDentsply Sirona Capsule Mixer recalled over electrical discharge risk when unplugged.
FDA•MODERATEIntersurgical One-Piece Guedel AirwayIntersurgical recalls One-Piece Guedel Airway, size 00, ISO 5.0, Blue, due to potential occlusion.
2 products- Device RecallFDA•MODERATEHamilton Microlab STAR PCT Software
Foundation Medicine recalls Hamilton Microlab STAR PCT v2.0.0 over spontaneous software closures.
FDA•MODERATEEndoFLIP 1 SystemCovidien recalls EndoFLIP 1 System due to 24-hour limit flagging products as expired.
2 products
FDA•MODERATEShoolin Pharma Chem: multiple drugsShoolin Pharma Chem recalls Sildenafil and Tadalafil APIs due to CGMP deviations.
5 products
FDA•MODERATEClear Eyes Maximum Itchy Eye ReliefClear Eyes Maximum Itchy Eye Relief recalled over potential sterility issues.
FDA•MODERATEPresource KitsCardinal Health is recalling multiple Presource procedural kits due to possible endotoxin contamination.
13 products
FDA•MODERATEBD Intravascular Administration and Extension SetsBD recalls IV administration and extension sets due to possible sterilization failure.
2 products
FDA•CRITICALOma's Pride Woof Complete Canine Chicken RecipeOma's Pride recalls Woof Complete Canine Chicken Recipe frozen dog food over potential Salmonella.
FDA•MODERATEMarketside Tomato Bisque Soup KitMarketside Tomato Bisque Soup Kit recalled due to possible Listeria contamination.
FDA•MODERATEERBECRYO 2 Cryosurgical UnitErbe USA recalls ERBECRYO 2 Cryosurgical Unit (Model 10402-000) over risk of cryoprobe rupture from CO2 leak.
FDA•MODERATEBIOFIRE Respiratory Panel 2.1BioFire recalls BIOFIRE Respiratory Panel 2.1 over increased false negatives.
FDA•CRITICALVitasia Asian Style Wok Spice MixVitasia Asian Style Wok Spice Mix recalled due to Salmonella.
FDA•MODERATEStraumann Bone Level Tapered ImplantStraumann recalls BLT Implant D 4.1mm RC SLActive 14mm due to possible 12mm length mismatch.
FDA•CRITICALBaxter Duo-Vent Solution SetBaxter recalls Duo-Vent Solution Set (1C8507) over air bubble risk in drip chamber and tubing.
FDA•CRITICALMorphine Sulfate Injection 2 mg/mL Prefilled SyringesFresenius Kabi recalls Morphine Sulfate 2 mg/mL syringes over a label mixup that may contain Dilaudid.
2 products
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.
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•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•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•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•CRITICALGlutathione 200 mg/mL InjectionVictory Medical Center Pharmacy recalls Glutathione 200 mg/mL vials over bacterial endotoxin contamination.
FDA•MODERATEMedline Hudson RCI Heated Breathing CircuitMedline recalls Hudson RCI heated breathing circuits for infants due to connector thermal damage risk.
5 products
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•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