FDA•MODERATE
Tosoh ST AIA-Pack Testosterone
Tosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
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Medical Devices Recalls
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FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor GAIN causing wrong output.
3 products
FDA•MODERATEMedline Total Knee Pack DYNJT6267Medline recalls Total Knee Pack DYNJT6267 over sterility breach risk from Zimmer Biomet mixing bowls and spatulas.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP One-Piece Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material risk.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic recalls Replacement Brush Heads model Papablic18B due to breakage risk.
2 products
FDA•MODERATEOrthofix MINIRAIL Standard LengthenerOrthofix recalls MINIRAIL Standard Lengthener Model M101 due to incorrect labeling.
8 products
FDA•MODERATEOptima XR200amx Radiographic SystemGE HealthCare recalls Optima XR200/220/240amx systems over risk of X-ray arm drop causing injury.
3 products
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
FDA•MODERATEICU Medical Plum Duo Infusion PumpICU Medical recalls Plum Duo Infusion Pump v1.2.3 due to risk of delivering up to twice the programmed volume.
2 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls pacing electrode trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALABIOMED Impella RP Flex Introducer SheathAbiomed recalls Impella RP Flex pump sets over introducer sheath leakage risk.
13 products
FDA•MODERATEOlympus Toomey Evacuator 30cc with AdaptorOlympus recalls Toomey Evacuator 30cc with Adaptor, Model 188, over sterilization concerns.
4 products
FDA•MODERATEVersius Surgeon ConsoleCMR Surgical is recalling the Versius Surgeon Console due to a cybersecurity risk involving the Secure Boot feature.
- Device RecallFDA•MODERATETMINI Miniature Robotic System Tracking Arrays
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.
FDA•MODERATEOmniTract Surgical Retractor SystemIntegra LifeSciences is recalling the OmniTract Surgical Retractor System due to insufficient drying time instructions in the user manual.
FDA•MODERATEGSP Neonatal GALT KitThe GSP Neonatal GALT Kit is recalled due to reduced on-board stability, which may cause test failures and delays in patient results.
FDA•MODERATEFletcher CT/MR Shielded Applicator SetElekta recalls Fletcher CT/MR Shielded Applicator Set over risk of intrauterine tube tip detachment.
3 products
FDA•MODERATEKlowen Custom Orthodontic SolutionKlowen is recalling the Custom Orthodontic Solution, model CIAS-800033, due to a defect that may cause incorrect bracket placement.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
FDA•MODERATEMedline Convenience KitsMedline recalls convenience kits with Covidien Mon-a-Therm probes due to distribution error.
3 products
FDA•MODERATEFresenius 5008X Blood Tubing SetsFresenius is recalling 5008X blood tubing sets due to potential connection errors between the tubing and the 5008X CAREsystem.
FDA•MODERATEIntracept Access InstrumentsBoston Scientific is recalling Intracept Access Instruments due to a potential sterile barrier breach that could lead to severe infection.
FDA•MODERATEEnovis EMPOWR 3D Knee InsertEncore Medical is recalling the EMPOWR 3D Knee Insert (11L 14MM) due to a packaging discrepancy involving incorrect product sizes.
2 products
FDA•MODERATEMasimo Radius VSM ECG Set and NIBP CuffMasimo recalls Radius VSM ECG Sets and NIBP Cuffs over false alarms and skin irritation risks.
2 products
FDA•MODERATEAquacel Ag Surgical SP DressingConvaTec is recalling Aquacel Ag Surgical SP dressings because they were manufactured with a thickness exceeding specifications.
FDA•MODERATEOlympus Single Use Distal CoverOlympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hoses over sterility breach risk.
2 products
FDA•MODERATEGore TAG Thoracic Branch Endoprosthesis Side Branch ComponentGore is recalling 30+ models of the TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation.
2 products
FDA•CRITICALReprocessed Electrophysiology and Ultrasound CathetersMedline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.
FDA•MODERATEBard Acute Drainage TraysBard recalls Acute Drainage trays due to deficient lidocaine ampoules from supplier.
20 products
FDA•CRITICALMedtronic Harmony Delivery Catheter SystemMedtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.
FDA•MODERATESolar GI System Water PerfusionLaborie is recalling Solar GI System configurations due to moisture accumulation that may affect pressure measurement performance.
FDA•MODERATECovidien Shiley Disposable Decannulation PlugCovidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
2 products
FDA•MODERATEZeiss Intrabeam Spherical ApplicatorZeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.
FDA•MODERATESiemens ARTIS icono Ceiling SuspensionSiemens is recalling the ARTIS icono ceiling suspension (Model 11328100) because monitor attachment screws may loosen over time.
FDA•CRITICALDSAEK Pack-RX Surgical Convenience KitWindstone Medical recalls DSAEK Pack-RX kits due to contaminated alcohol prep pads.
4 products- Device RecallFDA•MODERATERayCare 2024A SP1 Oncology Information Systems
RaySearch recalls RayCare 2024A SP1 over beam set delivery note data loss risk.
2 products 
FDA•CRITICALHillrom VOLARA System P.CIRCUIT KITBaxter recalls Hillrom VOLARA P.CIRCUIT KIT (REF M08085) over nebulizer cup leakage that may cause oxygen drop and ineffective treatment.
4 products
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Xchange Robotic Collimator Changer for the Cyberknife system due to a risk of the collimator falling from its housing.
FDA•MODERATEARTIS icono biplaneSiemens recalls ARTIS icono biplane over potential loss of detector lift movement.
3 products
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Cyberknife Xchange Robotic Collimator Changer due to a risk of the component falling from its housing.
FDA•MODERATECRE Pro Wireguided Dilatation BalloonBoston Scientific recalls CRE Pro Wireguided Dilatation Balloons over potential sterile pouch breach.
12 products
FDA•MODERATEIntelliCuff Portable Cuff Pressure ControllerThe IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.
FDA•MODERATEPilling Wecksorb NeurospongesTeleflex is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to potential out-of-specification levels of endotoxins.
2 products
FDA•MODERATEBaxter Adapter for Head PositioningBaxter is recalling the Adapter for Head Positioning due to a risk of the accessory becoming loose and moving during patient positioning.
FDA•MODERATERemel GC Agar BaseRemel is recalling GC Agar Base plates due to a risk of reduced or no recovery of Neisseria gonorrhoeae strains.
FDA•CRITICALHamilton Medical Ventilator Coaxial Breathing CircuitHamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.
FDA•MODERATEMedline Arterial Access TraysMedline recalls arterial access kits with Huons lidocaine ampules over quality issues.
19 products
FDA•MODERATEMedacta Shoulder System Short Monobloc Stem BroachesMedacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.