FDA•MODERATE
Zeiss Intrabeam Spherical Applicator
Zeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.
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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 Patient Circuit KitHillrom Volara circuit kits recalled over nebulizer cup leakage causing oxygen drops 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•MODERATESiemens ARTIS icono CeilingSiemens recalls ARTIS icono systems over potential loss of movement after detector lift adjustment.
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 Balloon DilatorBoston Scientific recalls CRE Pro Wireguided balloon dilators 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•CRITICALSpring & Mulberry Date-Sweetened ChocolateSpring & Mulberry is recalling Mango Chili and Pecan Date-Sweetened Chocolate bars due to potential Salmonella contamination.
11 products
FDA•MODERATELevothyroxine Sodium Tablets 300 mcgAccord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.
FDA•MODERATEprednisoLONE Acetate Ophthalmic Suspension 1%Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.
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•MODERATEImuldosa (ustekinumab-srlf) InjectionAccord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.
FDA•MODERATELe Chef Bakery: 2 productsLe Chef Bakery recalls Mini Tiramisu and Mini Italian Pastry Assortment for undeclared Yellow #5.
2 products
FDA•MODERATEMedline Convenience KitsMedline recalls convenience 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.
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with Swan-Ganz catheters over leak/breakage risk.
9 products
FDA•CRITICALHigh Valley Orchard Chocolate Covered RaisinsHigh Valley Orchard Chocolate Covered Raisins are recalled due to undeclared peanuts caused by a mis-packaging error.
FDA•MODERATEPovi-One 10% Povidone-Iodine Oral AntisepticElevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.
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•MODERATEPerampanel CIII TabletsSun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.
FDA•MODERATELacosamide 100mg TabletsCamber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
FDA•LOWHydroxyzine Hydrochloride Oral SolutionANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.
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•MODERATEDuloxetine Delayed-Release CapsulesDirect Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
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•MODERATEAmgen Corlanor and Sensipar TabletsAmgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 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•MODERATEMethylergonovine Maleate TabletsMajor Pharmaceuticals is recalling 0.2 mg Methylergonovine Maleate Tablets due to subpotency.
FDA•MODERATEFenofibrate Capsules, USP 200 mgAjanta Pharma is recalling Fenofibrate Capsules, USP 200 mg, due to manufacturing process deviations.
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•MODERATEMARS SNACKING: 2 productsMars Snacking recalls MorningStar Farms Buffalo Chik'n Nuggets and Sausage Patties over plastic contamination.
2 products
FDA•MODERATEKeystone Industries: multiple drugsKeystone recalls 20% benzocaine gels from 7 brands over defective container seals.
7 products