FDA•MODERATE
ID NOW Influenza A & B 2 Test Kit
Abbott is recalling ID NOW Influenza A & B 2 test kits (Model 427-000) due to an increased rate of invalid results.
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FDA•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.
FDA•MODERATEMedline Cardiac Procedure KitsMedline is recalling cardiac procedure kits to clarify that the included chest drainage units are intended for adult patients only.
FDA•MODERATEMedline Medcrest Surgical GownsMedline is recalling Medcrest surgical gowns due to fabric delamination risks that may lead to infection or delays in patient care.
3 products
FDA•MODERATELutronic CLARITY II Laser SystemLutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.
FDA•MODERATETemozolomide Capsules 5mgRising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
FDA•MODERATEAmnesteem Isotretinoin Capsules 40 mgMylan is recalling Amnesteem Isotretinoin 40 mg capsules (NDC 0378-6614-93) due to failed dissolution specifications.
FDA•MODERATESodium Iodide (I-131) Therapeutic Oral SolutionRadnostix is recalling Sodium Iodide (I-131) Therapeutic Oral Solution due to the presence of particulate matter.
FDA•MODERATEArtelon FlexBand Dynamic MatrixArtelon FlexBand Dynamic Matrix recalled over failed endotoxin testing.
3 products
FDA•MODERATEBeckman Coulter DxC 700 AU Chemistry AnalyzerBeckman Coulter recalls DxC 700 AU and AU5800 analyzers over software delay risk.
2 products- Device RecallFDA•MODERATEHealthCast Vital Sync Remote Patient Monitoring System
HealthCast is recalling Vital Sync software due to a failure to transmit or receive critical patient bedside monitor alarms.
2 products 
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to compromised seals on the included antiseptic swabsticks.
FDA•MODERATEEndo-Model Replacement PlateauEndo-Model Replacement Plateau is recalled due to a risk of bushing detachment from the screw shaft caused by longitudinal fractures.
13 products
FDA•MODERATEGEM Premier 5000 PAKInstrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause ejection and delay patient results.
20 products
FDA•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that could impact therapy delivery.
2 products
FDA•MODERATEAPTUS 2.5 TriLock ScrewsMedartis is recalling APTUS 2.5 TriLock Screws (model A-5750.16/1) due to a mix-up with 2.8mm screws.
2 products
FDA•MODERATEVegetarian Chicken Flavor RamenPalmetto Gourmet Foods is recalling Vegetarian Chicken Flavor Ramen 3oz packages due to undeclared Yellow #5.
2 products
FDA•MODERATERaz Mobile Shower Commode ChairsRaz Design is recalling various mobile shower commode chairs due to a seat bracket issue that may pose a fall risk to users.
2 products
FDA•MODERATEBD 10mL Non-Sterile Luer-Lok SyringeBD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.
FDA•MODERATEIBA Proton Therapy System PROTEUS 235IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
FDA•MODERATEHTO Nevada: Multiple Dermal Source ProductsKirkman recalls Vasocaine Spray and Zone 1/2 Lidocaine Creams over unsupported expiry dates.
3 products
FDA•MODERATEMedline Nail KitMedline is recalling the Nail Kit (model DYKM1528) because the included sterile saline wound wash may not meet sterility requirements.
5 products
FDA•LOWCipla: Multiple Packaged In Cartons CapsulesCipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.
2 products
FDA•MODERATEMidodrine Hydrochloride Tablets, USP 5 mgMajor Pharmaceuticals is recalling Midodrine Hydrochloride Tablets 5 mg (NDC 0904-6818-06) due to inadequately sealed blister packaging.
FDA•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 products- Device RecallFDA•MODERATEDatascope CS300 IABP
Datascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
2 products 
FDA•MODERATESTA Liatest Free Protein S KitDiagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.
FDA•MODERATEACME UNITED: multiple drugsAcme United is recalling 22 varieties of BZK Antiseptic Towelettes due to manufacturing process deviations.
22 products
FDA•MODERATESemaglutide Bulk APIHarbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.
2 products- Device RecallFDA•MODERATEB. Braun 21G Winged Infusion Set
B. Braun recalls 21G winged infusion sets due to risk of dull or broken needle tip.
3 products 
FDA•MODERATEAesculap Minop TrocarAesculap is recalling the Minop Trocar 150mm because the shaft may be too long.
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
FDA•MODERATESavannah Bee Honey BBQ Sauce MustardSavannah Bee Honey BBQ Sauce "Mustard" bottles may contain "Sweet" sauce with undeclared wheat and soy.
FDA•MODERATETeva Pharmaceuticals: multiple tabletsTeva recalls Metoprolol Succinate ER tablets (25-200 mg) over failed dissolution specs.
4 products
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
FDA•MODERATECobas Pro Integrated Solutions Analytical UnitsRoche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated test results.
2 products
FDA•MODERATEGE Healthcare Centricity Universal ViewerGE Healthcare is recalling Centricity Universal Viewer software due to a risk of patient information and image mismatch.
FDA•MODERATEOctopus Nuvo Tissue StabilizerMedtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATEAgiliti Adapt PumpAgiliti is recalling the Adapt Pump (model 61600200) for a software failure that prevents the Microclimate Management function from restarting.
FDA•MODERATEPure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep ResetPure Solutions recalling 1 fl oz sleep formula bottles due to undeclared milk allergen from bovine colostrum.
FDA•MODERATEMedline Apheresis and Dialysis KitsMedline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.
6 products
FDA•MODERATEEncore Medical Knee and Shoulder ImplantsEncore Medical is recalling EMPOWR 3D Knee and RSP Humeral Socket implants due to incorrect labeling.
3 products
FDA•MODERATEPIE PAK Trolley SystemEdermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
FDA•LOWEptifibatide Injection 75 mg/100 mLSlate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.
FDA•MODERATEAmantadine HCl Capsules 100 mgAvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.
FDA•MODERATEAdbry (tralokinumab-ldrm) InjectionLEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.
FDA•MODERATEGerber Arrowroot BiscuitsGerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.
FDA•MODERATEMcCain Foods: 2 productsMcCain Foods recalls Ore-Ida Tater Tots and Sonic Tots over possible small hard plastic fragments.
2 products
FDA•LOWSodexo Stars Saccharin PacketsDomino Foods recalls Sodexo Stars Saccharin Packets due to undeclared aspartame.