FDA•MODERATE
Ritmed Neurological Sponges
AMD Medicom recalls Ritmed Neurological Sponges due to elevated endotoxin risk; full REF list on FDA page.
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Medical Devices Recalls
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FDA•MODERATEdirectCHECK ACT-LR Whole Blood Quality ControlAccriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.
FDA•MODERATEMedtronic O-arm O2 Imaging SystemMedtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemHarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
2 products
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.
FDA•MODERATEMedline EBSI KitMedline recalls EBSI Kit (EBSI1534) due to cracked butyrate tubing and recalled MASTISOL adhesive.
42 products
FDA•CRITICALImpella Heart Pump Software RecallAbbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
FDA•CRITICALParacentesis KitArrow International recalls paracentesis kits due to supplier quality issues with included injectables, risking serious injury.
51 products
FDA•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits (AMPK48-01) over possible lack of sterilization.
4 products
FDA•MODERATEMOSAIQ Oncology Information SystemElekta is recalling the MOSAIQ Oncology Information System due to a software error that may prevent the loading of baseline shift plans.
FDA•MODERATEBoston Scientific Orca Air/Water and Suction ValvesBoston Scientific is recalling Orca single-use air/water and suction valves due to reports of the suction button sticking during use.
- Device RecallFDA•MODERATEMerlin Patient Care System Programmer Software
Abbott Medical is recalling Merlin PCS software for the Model 3330 programmer due to a potential failure to terminate pacing tests.
FDA•MODERATEBoston Scientific Clik X AnchorBoston Scientific is recalling the Clik X Anchor due to a potential lack of sterility assurance.
FDA•MODERATEBoston Scientific CSK ElectrodesBoston Scientific recalls CSK reusable electrodes over performance concerns.
4 products
FDA•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a GTIN labeling error that may result in the use of an incorrect potassium solution.
FDA•MODERATEAdvance Aluminum Chloride Gel Hemostatic KitInter-Med is recalling Aluminum Chloride Gel kits due to an incorrect package insert that provides dangerous first aid instructions.
FDA•MODERATEHintermann Series Talar ImplantDT MedTech is recalling the Hintermann Series Talar Implant due to a labeling error that may result in the wrong implant being used.
FDA•MODERATESiemens Dimension Tacrolimus Flex Reagent CartridgeSiemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.
FDA•MODERATEMedartis APTUS Cannulated Compression ScrewsMedartis is recalling APTUS cannulated compression screws due to a manufacturing defect where the cannulation is not centered.
FDA•MODERATEEXENT AnalyserThe Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.
FDA•MODERATENeoSpan SuperElastic Compression StapleIn2bones USA is recalling 10+ variants of NeoSpan compression staples due to missing MR Conditional safety labeling.
2 products
FDA•MODERATEMicromed SD LTM 64 PLUS EEG AmplifierMicromed is recalling SD LTM 64 PLUS EEG amplifiers due to a potential one-second temporal delay that may cause misinterpretation of results.
FDA•MODERATECGuard Prime Carotid Stent SystemInspireMD recalls CGuard Prime Carotid Stent System (model CND0830) due to deployment complications.
6 products
FDA•MODERATECORFLO Safety PEG KitAvanos recalls CORFLO Safety PEG Kit (model 30-4320) due to supplier-recalled lidocaine.
20 products
FDA•MODERATEMahurkar Elite PASS TraysMozarc Medical is recalling Mahurkar Elite PASS Trays because the Tegaderm CHG dressing is missing from the packaging.
2 products
FDA•MODERATEGE Allia IGS 3 Pulse Angiographic X-ray SystemGE recalls Allia IGS 3 Pulse X-ray systems over electrical shock risk to service personnel.
5 products
FDA•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a luer-lock leak issue that poses a slip and fall hazard.
FDA•MODERATEPlum Solo Precision IV PumpICU Medical recalls Plum Solo IV Pump over soft limit alert failure.
3 products
FDA•MODERATETDC VELOCE 23G Two Dimensional CutterD.O.R.C. recalls TDC VELOCE 23G cutter over loose outer knife risk.
3 products
FDA•MODERATEEXCOR Pediatric VAD Blood Pump PU ValvesBerlin Heart is recalling EXCOR Pediatric VAD Blood Pump PU Valves due to an expiration date mismatch that could delay surgical procedures.
FDA•MODERATESporeTraq Mail-In Spore Testing ServiceSporeTraq Mail-In Spore Testing Service recalled due to incorrect incubation process; model 1023780.
4 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling Sharpoint microsurgical knives mislabeled as 2.2mm when they are actually 3.0mm.
FDA•CRITICALKayserBett IDA Pediatric Care BedKayserBett is recalling the IDA pediatric care bed due to an entrapment risk if the hand control is not locked while the child is unattended.
FDA•MODERATEGrace Medical Stapes ProsthesisGrace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
FDA•MODERATEDa Vinci 5 NIR Handheld CameraIntuitive Surgical is recalling the da Vinci 5 NIR handheld camera system due to a risk of unintentional illumination activation.
2 products
FDA•MODERATEDeRoyal Covaderm Plus Vascular Access DressingDeRoyal is recalling Covaderm Plus Vascular Access Dressing (Ref 46-406) due to a lack of sterility assurance.
FDA•MODERATEAligned Medical Fluids KitWindstone Medical Packaging is recalling Aligned Medical AMS16835 Fluids Kits due to a supplier recall of the included Lidocaine injection.
- Device RecallFDA•CRITICALIvenix Infusion System LVP Software
Fresenius Kabi is recalling Ivenix Infusion System LVP software due to a potential battery-health reporting error that may cause pump shutdown.
FDA•MODERATEGE MAC 5 A4 and A5 Resting ECG Analysis SystemsGE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
FDA•MODERATEBD Pyxis MedStation 4000 Fingerprint ScannerBD Pyxis MedStation 4000 recalled: fingerprint scanner may overheat, causing burns.
8 products
FDA•MODERATEMedrad Avanta Injection System Tube SetsBayer is recalling Avanta Multi-Patient Administration Tube Sets due to a fit issue that may cause connection instability during use.
FDA•CRITICALPencan Spinal Needle TraysB. Braun recalls Pencan spinal needle trays over potential quality issues with bupivacaine component.
6 products
FDA•MODERATEArvis Hip & Knee 3.0 Instrument SetKico recalls Arvis Hip & Knee 3.0 Instrument Set over magnet face wear/corrosion.
2 products
FDA•MODERATEShimadzu X-Ray Systems High Voltage GeneratorShimadzu recalls X-ray systems over generator contactor weld risk; full model list on FDA page.
2 products
FDA•MODERATEPhaseOne Antimicrobial Solution SprayerOculus Technologies is recalling PhaseOne Antimicrobial Solution due to sprayer spring corrosion that may contaminate the product.
FDA•MODERATECASE v7.0 Cardiac Testing SystemGE Medical is recalling the CASE v7.0 Cardiac Testing System due to a risk of electrical sparking at the printer head.
FDA•MODERATEHiRes Ultra 3D CI HiFocus Mid Scala Cochlear ImplantAdvanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.
2 products
FDA•MODERATENeptune Smart Docking StationStryker is recalling the Neptune Smart Docking Station (120V) due to missing safety testing and a potential electrical shock risk.
FDA•MODERATECovidien EndoStitch Polysorb Single Use Loading UnitCovidien is recalling EndoStitch Polysorb loading units (170053, 170071) due to packaging holes that may compromise sterility.
FDA•CRITICALIvenix Large Volume PumpFresenius Kabi is recalling Ivenix Large Volume Pumps due to potential touchscreen malfunctions caused by internal damage from drops or jarring.