FDA•MODERATE
Stryker InZone Detachment System
Stryker is recalling the InZone Detachment System due to premature battery drain that may prevent coil detachment during medical procedures.
Medical Devices Recalls
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FDA•MODERATEAcumed Hexalobe ScrewsAcumed is recalling various hexalobe screws used in wrist fixation systems due to a risk of the screws breaking during use.
2 products
FDA•MODERATEZimmer Off-Axis Comprehensive Shoulder Reamer GuideZimmer recalls Off-Axis Shoulder Reamer Guide Model 110040240 due to breakage risk.
5 products
FDA•MODERATEPFM Medical Multi-Snare SetPFM Medical is recalling Multi-Snare Set catheter devices due to a failure to meet biocompatibility requirements for in-vitro cytotoxicity.
FDA•MODERATEVentec VOCSN+Pro Respiratory SystemVentec is recalling the VOCSN+Pro respiratory system because a damaged battery may prevent the backup alarm from sounding during power loss.
FDA•MODERATEPhilips Avalon Fetal Monitor FM20Philips recalls Avalon Fetal Monitor FM20 over speaker connector assembly issue causing cable pull-out and loss of speaker output.
2 products
FDA•MODERATEDa Vinci Surgical System E-Brake Retainer PinIntuitive Surgical is recalling the Da Vinci surgical system E-brake retainer pin due to a risk of uncontrolled motion and patient injury.
FDA•MODERATETMJ Bilateral ImplantsTMJ Solutions is recalling custom temporomandibular joint implants due to incorrect components causing a poor fit and potential open bite.
FDA•CRITICALGiraffe Stand-alone Infant Resuscitation System Blender KnobDatex-Ohmeda recalls Giraffe Infant Resuscitation System over blender knob that may cause incorrect oxygen delivery.
3 products- Device RecallFDA•MODERATEHeartMate 3 LVAS Backup Battery
HeartMate 3 LVAS kits recalled due to backup battery failures.
6 products - Device RecallFDA•MODERATESTAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
2 products 
FDA•MODERATEInspire Respiratory Sensing LeadInspire Medical recalls Respiratory Sensing Lead Model 4340 due to incorrect Use By dates that may cause premature revision surgery.
3 products
FDA•CRITICALImpella CP Set with SmartAssistAbiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
FDA•MODERATEBD Connecta Luer-Lok StopcockBD is recalling Connecta Luer-Lok stopcocks due to a potential connection failure at Port C when using plastic luer-lok syringes.
FDA•MODERATESplashwire Hydrophilic Guide WireMerit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.
2 products
FDA•MODERATETriathlon Universal BaseplateStryker recalls Triathlon Universal Baseplate due to packaging mix-up between Size 3 and Size 4.
2 products
FDA•MODERATEMedline Red Rubber Latex Urethral CatheterMedline recalls Red Rubber Latex Urethral Catheters over surface, connector, and size defects.
34 products
FDA•MODERATEGiraffe OmniBed Canopy SoffitGE HealthCare recalls Giraffe OmniBed over canopy soffit fasteners that may disengage, risking patient injury.
3 products
FDA•MODERATEConMed AirSeal 5 mm Smooth Access Port and ObturatorConMed recalls AirSeal 5 mm trocar (iASB5-150) over overpressure alert risk.
11 products
FDA•MODERATEPhilips MultiDiagnost ElevaPhilips recalls MultiDiagnost Eleva systems over hand switch button that may not fully release, risking radiation exposure.
3 products
FDA•MODERATERitmed Neurological SpongesAMD Medicom recalls Ritmed Neurological Sponges (7+ variants) over elevated endotoxin risk; full REF list on FDA page.
2 products
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•MODERATETrigen Proximal Straight Humeral NailSmith & Nephew is recalling the Trigen Proximal Straight Humeral Nail due to a manufacturing error that may cause surgical delays or revision.
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 SystemSteris recalls HarmonyAIR A-Series Surgical Lighting System due to detachable light intensity buttons.
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•CRITICALParacentesis KitArrow recalls paracentesis kits over supplier drug quality issues that may cause serious injury.
51 products
FDA•MODERATEMedline EBSI Kit EBSI1534Medline recalls EBSI Kit EBSI1534 due to cracked tubing and recalled adhesive.
42 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling 30+ models of Impella Controllers due to a software error that may affect left ventricular support devices.
2 products
FDA•MODERATEFresh Roast Systems ColorTrack InstrumentFresh Roast Systems is recalling the ColorTrack instrument (Model BENCH R-100) due to a potential laser safety hazard.
FDA•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits (AMPK48-01) due to unsterilized pouches.
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 Electrodes over potential performance issues.
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•MODERATEPhilips DigitalDiagnost C90 Wall StandPhilips is recalling DigitalDiagnost C90 systems because the Wall Stand VS2 lacks a required seismic stability kit.
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 quality issues with lidocaine injection.
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•MODERATEAllia IGS 3 Pulse angiographic X-ray systemGE HealthCare 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.