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Medline Convenience Kits with Swan-Ganz Catheters
Medline recalls convenience kits with Swan-Ganz catheters over leak/breakage risk.
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Medical Devices Recalls
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FDA•MODERATEMentor Luer Lok 10cc SyringesMentor is recalling a lot of 10cc Luer Lok syringes that were distributed after their expiration date.
FDA•MODERATEIntera 3000 Hepatic Artery Infusion PumpBoston Scientific recalls Intera 3000 pump over drug pathway leakage risk.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL polycarbonate syringes over unapproved design changes.
23 products
FDA•CRITICALAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CPAbiomed recalls Impella CP introducer kit over thrombus risk.
4 products
FDA•MODERATEPhilips Telemetry Monitor 5500Philips is recalling Telemetry Monitor 5500 units due to a potential reset error that prevents connection to the central monitoring system.
- Device RecallFDA•MODERATEThuvera Laser Console
IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.
FDA•CRITICALMedline Convenience KitsMedline recalls convenience kits with recalled lidocaine and bupivacaine injections due to supplier quality issues.
5 products
FDA•MODERATEGE Healthcare AW Server 3.2 ext.6.5GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.
FDA•MODERATEOctopus Evolution Tissue StabilizerMedtronic recalls Octopus Evolution Tissue Stabilizer over incorrect tubing assembly.
3 products
FDA•MODERATESurgify Halo Drill BurrSurgify Halo drill burr recalled over breakage risk during spinal surgery.
19 products
FDA•MODERATEStryker InZone Detachment SystemStryker is recalling the InZone Detachment System due to premature battery drain that may prevent coil detachment during medical procedures.
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 System Reamer GuideZimmer recalls shoulder reamer guides due to breakage risk; 5 complaints reported.
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.
- 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•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 finish and connector issues.
34 products
FDA•MODERATEGiraffe OmniBed Canopy Soffit FastenersGE HealthCare recalls Giraffe OmniBed over canopy soffit fasteners that may disengage, risking patient injury.
3 products
FDA•MODERATEConMed AirSeal Access Port and ObturatorConMed recalls AirSeal access ports and obturators over potential overpressure alerts.
11 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•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 Lights due to detachable intensity buttons that may fall into the sterile field.
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 Convenience KitsMedline recalls convenience kits over cracked tubing risk from MASTISOL 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•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits over 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•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 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