FDA•CRITICAL
Cetirizine Hydrochloride Tablets 5 mg
Rising Pharma recalls Cetirizine HCl 5 mg tablets due to ranitidine cross-contamination.
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FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgMajor Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
FDA•LOWTrokendi XR Topiramate ER Capsules 25mgSupernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products
FDA•MODERATEDivalproex Sodium Delayed-Release Tablets 500 mgBionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor gain causing inaccurate output.
3 products
FDA•MODERATEMedline Total Knee Pack Mixing Bowls and SpatulasMedline recalls Total Knee Pack kits with Zimmer Biomet mixing bowls and spatulas over sterility risk.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material with trace blood.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic is recalling replacement brush heads over a choking hazard from breakage.
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•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls carbamide peroxide 6.5% earwax removers (CVS Health, Clinere, TopCare, etc.) for subpotency.
11 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 XR200amx Radiographic SystemGE HealthCare recalls Optima XR200/220/240amx systems after column replacement due to risk of arm drop and patient injury.
3 products
FDA•MODERATEFunctional Formularies: 2 productsNutricia recalls Liquid Hope and Nourish organic meal replacement formulas 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 VTBI.
2 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•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•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•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•MODERATEMethohexital Sodium 100 mg/10 mLQuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.
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•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•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•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