FDA•MODERATE
Boston Scientific Rapid Refill Continuous Injection System
Boston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
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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•MODERATEPemetrexed for Injection 100mg/VialSomerset Therapeutics recalls Pemetrexed for Injection 100mg/Vial due to cGMP deviations.
4 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•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in multiple sizes due to subpotency, which may reduce antiseptic effectiveness.
6 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•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedVitalant is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated due to missing white blood cell count verification testing.
FDA•CRITICALFresh & Ready Foods: 2 productsFresh to You Burger Chicken Fillet sandwiches recalled over possible Salmonella from raw breaded patties.
2 products
FDA•CRITICALOrganic Moringa Leaf PowderTrafa Pharmaceuticals is recalling 15 kg bags of Organic Moringa Leaf Powder due to potential Salmonella contamination.
FDA•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
FDA•MODERATEVanilla Dessert ShellsSpecialty Bakers recalls Giant Vanilla Dessert Shells over undeclared soy allergen.
FDA•MODERATEAlabama Banana Pudding MarshmallowWondermade is recalling 4 oz packages of Alabama Banana Pudding Marshmallow due to potential metal contamination.
FDA•MODERATEMedline Remedy Specialized Silicone CreamMedline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.
FDA•MODERATEClomiphene Citrate USP Active Pharmaceutical IngredientShimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations.
FDA•MODERATESuper Healthy Hair Blow Dry SprayBeauty Pie is recalling Super Healthy Hair Blow Dry Spray (150 ml) due to potential contamination with Pseudomonas aeruginosa.
FDA•MODERATEMethohexital Sodium for Injection 500 mgAvet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.
FDA•MODERATEAquacel Ag Surgical SP DressingConvaTec is recalling Aquacel Ag Surgical SP dressings because they were manufactured with a thickness exceeding specifications.
FDA•MODERATEWise Onion RingsWise Foods is recalling 3.75 oz bags of Onion Rings due to undeclared colors and the presence of an unapproved color additive.
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•CRITICALAdams Extract & Spice: 5 productsAdams Extract recalls multiple seasonings due to undeclared sesame allergen.
5 products
FDA•CRITICALOrganic Whole BlueberriesFrutas y Hortalizas del Sur S.A. is recalling 10 oz bags of Organic Whole Blueberries due to potential E. coli O145:H28 contamination.
FDA•MODERATEPedigree High Protein Chopped Ground DinnerMars Petcare is recalling Pedigree High Protein Chopped Ground Dinner over potential contamination with plastic and metal foreign material.
FSIS•MODERATEBeef Jerky with Undeclared WheatFSIS issued a public health alert for a ready-to-eat beef jerky product due to misbranding and an undeclared wheat allergen.
FDA•CRITICALFusia Asian Inspirations Kimchi & Tofu KimbapFusia Kimchi & Tofu Kimbap recalled due to undeclared fish allergen.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets due to nitrosamine impurity above ADI.
3 products
FDA•MODERATEDextroamphetamine/Amphetamine Extended-Release CapsulesLannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.
FDA•MODERATEAsclemed: Multiple Lidocaine Hcl InjectionsAsclemed recalls Accucaine kits and Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL ampules due to lack of sterility assurance.
2 products
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.