FDA•MODERATE
Olympus 4K UHD LCD Monitor
Olympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
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Medical Devices Recalls
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FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and FARAPOINT CatheterBoston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.
3 products
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor gain causing inaccurate output.
3 products
FDA•MODERATEMedline Total Knee Pack Mixing Bowls and SpatulasMedline recalls Total Knee Pack kits with Zimmer Biomet mixing bowls and spatulas over sterility risk.
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 Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material with trace blood.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic is recalling replacement brush heads over a choking hazard from breakage.
2 products
FDA•MODERATEOrthofix MINIRAIL Standard LengthenerOrthofix recalls MINIRAIL Standard Lengthener (M101) over incorrect labeling.
8 products
FDA•MODERATEOptima XR200amx Radiographic SystemGE HealthCare recalls Optima XR200/220/240amx systems after column replacement due to risk of arm drop and patient 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 VTBI.
2 products
FDA•CRITICALOscor Impella Introducer KitOscor recalls Abiomed Impella Introducer Kit (14F) due to sheath leakage risk.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon recalls Transvenous Pacing Electrode Trays due to non-sterile lidocaine ampules in kits.
6 products
FDA•CRITICALAbiomed Impella RP Flex IntroducerAbiomed recalls Impella RP Flex introducers over sheath leakage risk.
13 products
FDA•MODERATEOlympus Toomey Evacuator 30ccOlympus recalls Toomey Evacuator 30cc (Model 188) over sterilization failure risk.
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•MODERATEVitek 2 AST-N447 Test KitBiomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant results caused by pouch foil fractures.
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 applicator set due to risk of IU 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•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G Insulin Pumps due to a software error that can cause the device to unexpectedly stop delivering insulin.
FDA•MODERATEMedline Anesthesia Kit Peds 90-LFMedline recalls Anesthesia Kit Peds 90-LF due to included temperature probe distribution error.
3 products
FDA•MODERATE5008X Blood Tubing SetsFresenius recalls 5008X Blood Tubing Sets over potential online port errors.
2 products
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 NIBP Cuff and ECG SetMasimo recalls Radius VSM NIBP cuffs and ECG sets over false heart-rate alarms and cuff edge irritation.
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 Hose (Model 60-1812-101-00) due to sterility breach risk.
2 products
FDA•MODERATEGORE TAG Thoracic Branch EndoprosthesisW.L. Gore & Associates is recalling its GORE TAG Thoracic Branch Endoprosthesis due to a device defect.
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 lidocaine ampoules made under deficient practices.
20 products
FDA•MODERATEMedline Gravity SetMedline is recalling gravity sets labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.
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 recalls Shiley Disposable Decannulation Plug over incorrect non-DEHP labeling; product contains 30-35% DEHP.
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 KitDSAEK Pack-RX kits recalled due to contaminated alcohol prep pads; stop use and contact firm.
4 products