FDA•MODERATE
RayCare 2024A SP1 Oncology Information Systems
RaySearch recalls RayCare 2024A SP1 oncology software due to potential data loss in beam set delivery notes.
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FDA•CRITICALHillrom Volara System Patient Circuit KitBaxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing 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 movement after detector lift height 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 DilatorBoston Scientific recalls CRE Pro Wireguided dilator due to 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•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•LOWFexofenadine Hydrochloride Tablets 180 mgOhm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.
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 due to undeclared Yellow #5.
2 products
FDA•MODERATEMedline Convenience Kits with LidocaineMedline recalls 3 convenience kits with Huons Lidocaine ampules due to 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•CRITICALTNVitamins Organic Moringa Capsules and PowderTNVitamins Organic Moringa Capsules and Powder recalled due to possible Salmonella contamination.
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with BD Swan-Ganz catheters due to hub failure risk.
9 products
FDA•CRITICALHigh Valley Orchard Chocolate: 2 productsHigh Valley Orchard Chocolate Covered Raisins recalled over undeclared peanut allergen.
2 products
CPSC•Treatlife Smoke and Carbon Monoxide DetectorsTreatlife smoke and CO detectors are recalled because they may fail to alert users to a fire, posing a risk of injury or death.
CPSC•Amana Air Conditioners and Heat PumpsAmana air conditioners and heat pumps are recalled due to a fire and burn hazard caused by a faulty heating element.
CPSC•Honlyne LED Party FavorsHonlyne LED party favors (Model HON-302HE) are recalled due to a button cell battery ingestion hazard that can cause serious injury or death.
CPSC•Kith Children's Loungewear SetsKith is recalling children's loungewear sets due to a violation of federal flammability standards, posing a risk of serious burn injuries.
CPSC•Small Fish Montessori Busy BoardSmall Fish Montessori Busy Board (model 2512JX02) is recalled due to a magnet ingestion hazard that can cause serious injury or death.
CPSC•Raychy Children's Light SneakersRaychy children's light-up sneakers are recalled due to a serious battery ingestion hazard from accessible lithium coin batteries.
CPSC•Lomi Roll-On Waxing KitsLomi Roll-On Waxing Kits are recalled because the warmer's power cord can overheat, posing fire, burn, and shock hazards.
CPSC•Sunderwell Youth Electric ATVsSunderwell XW-A17 youth electric ATVs are recalled for missing brake lights, which poses a crash hazard and violates federal safety standards.
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 PumpIntera 3000 Hepatic Artery Infusion Pump recalled over potential drug pathway leakage.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL polycarbonate syringes due to unapproved design changes.
23 products
FDA•CRITICALAbiomed Impella CP Introducer KitAbiomed recalls Impella CP introducer kit (14 Fr x 13 cm) 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 CV Anesthesia Room Setup KitsMedline recalls CV Anesthesia Room Setup kits due to quality issues with included lidocaine and bupivacaine injections.
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 TS2000 due to incorrect tubing assembly.
3 products
FDA•MODERATESurgify Halo BurrSurgify Halo 3.0 mm burr recalled due to potential breakage 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 Reamer GuideZimmer recalls Off-Axis Reamer Guide (Model 110040240) due to breakage risk from catching during reaming.
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.