FDA•MODERATE
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
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FDA•MODERATEMedtronic DLP One-Piece Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material risk.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic recalls Replacement Brush Heads model Papablic18B due to breakage risk.
2 products
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEAmy's Organic Lentil Soup Light in SodiumAmy's is recalling 14.5 oz cans of Organic Lentil Soup Light in Sodium due to potential spoilage.
FDA•MODERATEOla-Ola Pounded GroundnutsOla-Ola Pounded Groundnuts are recalled due to undeclared peanuts, posing a risk to consumers with peanut allergies.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products
FDA•MODERATEWY Duck Sauce PacketsW.Y. Industries is recalling 0.35 oz. packets of WY Duck Sauce due to potential metal fragment contamination.
FDA•MODERATEOrthofix MINIRAIL External Fixation DeviceOrthofix recalls MINIRAIL external fixation devices due to incorrect labeling.
8 products
FDA•MODERATERuby Quartered Artichoke HeartsRuby Quartered Artichoke Hearts are being recalled due to potential glass contamination.
FDA•MODERATEWinfield's CWB Chocolate BarsWinfield's CWB Chocolate Bars recalled for undeclared milk allergen.
FDA•MODERATEPillsbury Bread Rolls: Hard Roll Dough and Kaiser Roll DoughGeneral Mills is recalling Pillsbury Hard and Kaiser roll dough products due to potential glass contamination.
2 products
FDA•MODERATENystatin Cream USPPadagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.
FDA•MODERATEOptima XR200/220/240amx Column Safety PawlGE HealthCare recalls Optima XR200/220/240amx systems over column safety pawl testing issue that could cause arm drop and patient injury.
3 products
FDA•MODERATENutricia North America: 2 productsNutricia recalls Liquid Hope and Nourish organic meal replacements due to subpotent vitamin A.
2 products
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
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 volume.
2 products
FDA•MODERATEOlympus Toomey Evacuator 30cc with AdaptorOlympus recalls Toomey Evacuator 30cc with Adaptor, Model 188, over sterilization concerns.
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 Shielded Applicator Set over risk of intrauterine tube tip detachment.
3 products
FDA•MODERATEPemetrexed for Injection 100mg/VialReliance Life Sciences recalls Pemetrexed for Injection 100mg/Vial over 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 Convenience KitsMedline recalls convenience kits with Medtronic temperature probes due to distribution error.
3 products
FDA•MODERATEGasco Industrial: Multiple Isopropyl Alcohol ProductsGasco recalls Isopropyl Alcohol 70% in 16 oz, 32 oz, and 1 gal sizes due to subpotency.
6 products
FDA•MODERATEFresenius 5008X Blood Tubing SetsFresenius is recalling 5008X blood tubing sets due to potential connection errors between the tubing and the 5008X CAREsystem.
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 ECG Set and NIBP CuffMasimo recalls Radius VSM ECG Sets and NIBP Cuffs over false alarms and skin irritation risks.
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•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 is recalling Vanilla Dessert Shells due to an 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•MODERATEPedigree High Protein Chopped Ground DinnerMars Petcare is recalling Pedigree High Protein Chopped Ground Dinner over potential contamination with plastic and metal foreign material.
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-nitroso impurity above safe limit.
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 Injection ProductsAsclemed recalls Accucaine kits and Lidocaine HCl injection ampules over sterility concerns.
2 products
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hoses over sterility breach risk.
2 products