FDA•MODERATE
Atellica CH Urine Albumin Test
Siemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
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FSIS•MODERATEPunahele Jerky Beef CrispsPunahele Jerky beef crisps recalled for undeclared soy allergen; best by 2/17/2027 or prior.
4 products
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.
FSIS•CRITICALBremer Italian Style MeatballsRosina recalls frozen Bremer Italian Style Meatballs over possible metal contamination.
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•CRITICALUdenyca Pegfilgrastim-cbqv InjectionAccord BioPharma is recalling Udenyca injection due to improper storage temperature conditions.
FDA•MODERATEOxycodone Hydrochloride 5 mg TabletsAmerican Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.
FDA•MODERATECetrorelix Acetate Injection KitMeitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.
FDA•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
FDA•MODERATELaerdal Compact Suction Unit 4 RTCALaerdal is recalling LCSU 4 RTCA suction units due to potential electromagnetic noise levels exceeding regulatory limits.
FDA•MODERATEMedline Surgical and Biopsy Convenience KitsMedline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.
62 products
FDA•MODERATEAuris Health MONARCH Platform Bronchoscopy SystemAuris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.
FDA•MODERATEMOLLI 2 Surgical Marker SystemStryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
FDA•CRITICALRosabella Moringa Dietary Supplement CapsulesAmbrosia Brands is recalling Rosabella Moringa dietary supplement capsules due to potential Salmonella contamination.
FDA•MODERATEThiamine HCl Injection 500 mg/100 mLFresenius Kabi recalls thiamine HCl 500 mg/100 mL IV bags over sterility concerns.
5 products
FDA•MODERATEMediHoney Gel DressingIntegra LifeSciences is recalling MediHoney Gel dressing models 31805 and 31815 due to a potential breach in the sterile packaging barrier.
3 products
FDA•MODERATETestosterone 100 mg Sterile PelletsAsteria Health recalls Testosterone 100 mg Sterile Pellets over possible metal contamination.
25 products
FDA•MODERATEDiclofenac Sodium Topical Gel 3%Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.
FDA•LOWDoxazosin Tablets, USP 4 mgUnichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.
FDA•MODERATETrazodone Hydrochloride 50 mg TabletsGranules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.
- Device RecallFDA•MODERATEPhilips Azurion 5 M20 and 7 M12 Systems
Philips recalls Azurion 5 M20 and 7 M12 systems over risk of unexpected table movement when Reset Geometry is pressed.
8 products 
FDA•MODERATEAlphatec Spine Lateral Navigation Disc Prep InstrumentsAlphatec Spine is recalling 10mm Osteotome navigation instruments due to a design flaw in the array connection geometry.
2 products
FDA•MODERATEWinCo Foods Deli Margherita PizzaWinCo Foods is recalling Deli Margherita Pizza Thin Crust due to potential metal fragment contamination.
FDA•MODERATEPro Numb Tattoo Numbing SprayPro Numb Tattoo Numbing Spray recalled over cGMP deviations.
2 products
FDA•MODERATEHalyard Transport Bag Kit LIFE0080-01Halyard Transport Bag Kit LIFE0080-01 recalled due to Tyvek bag seal issue that may compromise sterility.
FDA•LOWStraumann WB Impression Post Closed TrayStraumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.
FDA•CRITICALTRUE METRIX Blood Glucose Meter InstructionsTrividia recalls TRUE METRIX meter instructions over inadequate E-5 error guidance.
7 products
FDA•MODERATEPhilips Brilliance iCT Gantry Rotor FastenersPhilips is recalling Brilliance iCT systems due to a risk of rotor parts becoming unsecured and potentially expelled during gantry rotation.
4 products
FDA•MODERATEOlympus Single Use 3-Lumen Sphincterotome VOlympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1520) due to a risk of deformation and performance loss.
30 products
FDA•MODERATEMaquet Venous Bubble SensorMaquet is recalling the Venous Bubble Sensor (Model 701055720) due to cable durability issues that may cause device errors.
FDA•MODERATEFDR Visionary Suite X-ray GeneratorFUJIFILM is recalling FDR Visionary Suite X-ray generators due to a risk of overheating and smoke caused by faulty electromagnetic contactors.
FDA•CRITICALPrime Food Processing Dried Croaker FishPrime Food Processing is recalling 8 oz packages of Dried Croaker Fish due to the risk of Clostridium botulinum toxin contamination.
FDA•MODERATEVITEK 2 Gram-negative Susceptibility CardsBiomerieux is recalling 30+ VITEK 2 susceptibility cards due to potential quality control failures and false resistant test results.
2 products
FDA•MODERATEPrismaflex M100 SetVantive is recalling the Prismaflex M100 Set due to a potential dislodgement of the deaeration chamber from the control unit.
8 products
FDA•MODERATEEncore Medical EMPOWR Acetabular and Knee InsertsEncore Medical is recalling EMPOWR acetabular liners and knee inserts due to a packaging discrepancy that may cause surgical delays.
2 products