Device Recall
FDA•MODERATE
HeartMate 3 LVAS Backup Battery
HeartMate 3 LVAS kits recalled due to backup battery failures.
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All Recalls
Back to home ←- Device RecallFDA•MODERATESTAAR ICL Calculation Software
Staar Surgical is recalling Version 8.00 of its ICL Calculation Software due to a coding error affecting toric lens orientation diagrams.
2 products 
FDA•MODERATEInspire Respiratory Sensing LeadInspire Medical recalls Respiratory Sensing Lead Model 4340 due to incorrect Use By dates that may cause premature revision surgery.
3 products
FDA•CRITICALImpella CP Set with SmartAssistAbiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
FDA•MODERATEBD Connecta Luer-Lok StopcockBD is recalling Connecta Luer-Lok stopcocks due to a potential connection failure at Port C when using plastic luer-lok syringes.
FDA•MODERATESplashwire Hydrophilic Guide WireMerit Medical is recalling various Splashwire Hydrophilic Guide Wire models due to unsealed pouches that may compromise device sterility.
2 products
FDA•MODERATEBuprenorphine HCl InjectionPar Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
FDA•MODERATETriathlon Universal BaseplateStryker recalls Triathlon Universal Baseplate due to packaging mix-up between Size 3 and Size 4.
2 products
FDA•MODERATEMedline Red Rubber Latex Urethral CatheterMedline recalls Red Rubber Latex Urethral Catheters over surface finish and connector issues.
34 products
FDA•MODERATEGiraffe OmniBed Canopy Soffit FastenersGE HealthCare recalls Giraffe OmniBed over canopy soffit fasteners that may disengage, risking patient injury.
3 products
FDA•MODERATEConMed AirSeal Access Port and ObturatorConMed recalls AirSeal access ports and obturators over potential overpressure alerts.
11 products
FDA•CRITICALTaro CakesE & S Grocery & Bakery is recalling Taro Cakes due to an undeclared egg allergen.
FDA•MODERATENutrisystem Chocolate CheesecakeNutrisystem is recalling Chocolate Cheesecake 2 oz packages due to an undeclared soy allergen.
FDA•MODERATEGreat Value Hawaiian Roll 4pkGreat Value Hawaiian Roll 4pk recalled due to oily substance on packaging; product never reached consumers.
FDA•MODERATEdirectCHECK ACT-LR Whole Blood Quality ControlAccriva Diagnostics is recalling directCHECK ACT-LR whole blood quality control, level 2, due to incorrect performance range labeling.
FDA•MODERATEAripiprazole 30 mg TabletsAjanta Pharma is recalling Aripiprazole 30 mg tablets due to a mix-up with Voriconazole 50 mg tablets.
FDA•MODERATEMedtronic O-arm O2 Imaging SystemMedtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris recalls HarmonyAIR A-Series Surgical Lights due to detachable intensity buttons that may fall into the sterile field.
2 products
FDA•MODERATEHarmonyAIR A-Series Surgical Lighting SystemSteris is recalling HarmonyAIR A-Series Surgical Lighting Systems due to a risk of paint delamination on the light heads.
FDA•CRITICALNara Organics Whole Milk Organic Infant FormulaNara Organics is recalling Whole Milk Organic Infant Formula over potential Clostridium botulinum contamination.
FDA•CRITICALParacentesis KitArrow recalls paracentesis kits over supplier drug quality issues that may cause serious injury.
51 products
FDA•MODERATEDabur India: Multiple Made In India ProductsDabur India recalls 14 OTC topical products over CGMP deviations.
14 products
FDA•MODERATEChlorthalidone 25 mg TabletsChlorthalidone 25 mg tablets are being recalled due to failed dissolution specifications.
FDA•LOWFocalin XR 5 mg CapsulesSandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
FDA•MODERATEAlyacen 7/7/7 TabletsGlenmark is recalling Alyacen 7/7/7 tablets due to out-of-specification results for total impurities.
FDA•MODERATEVasopressin 2 Units/2 mL SyringesIntegraDose is recalling Vasopressin 2 Units/2 mL syringes due to subpotency, which may cause the drug to be ineffective.
FDA•MODERATEPAI: Multiple Kerr Insta-char In An ProductsPAI Holdings recalls KERR INSTA-CHAR charcoal products for failing USP/OTC monograph standards.
4 products
FDA•MODERATEMedline Convenience KitsMedline recalls convenience kits over cracked tubing risk from MASTISOL adhesive.
42 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling 30+ models of Impella Controllers due to a software error that may affect left ventricular support devices.
2 products
FDA•CRITICALAzuma Foods Tako Wasabi Seasoned OctopusAzuma Foods is recalling Tako Wasabi Seasoned Octopus due to undeclared fish.
FDA•MODERATEHalyard Pain PackAVID Medical recalls Halyard Pain Pack kits over unsterilized pouches.
4 products
FDA•MODERATEMOSAIQ Oncology Information SystemElekta is recalling the MOSAIQ Oncology Information System due to a software error that may prevent the loading of baseline shift plans.
FDA•MODERATEBoston Scientific Orca Air/Water and Suction ValvesBoston Scientific is recalling Orca single-use air/water and suction valves due to reports of the suction button sticking during use.
- Device RecallFDA•MODERATEMerlin Patient Care System Programmer Software
Abbott Medical is recalling Merlin PCS software for the Model 3330 programmer due to a potential failure to terminate pacing tests.
FDA•MODERATEBoston Scientific Clik X AnchorBoston Scientific is recalling the Clik X Anchor due to a potential lack of sterility assurance.
FDA•MODERATEBoston Scientific CSK ElectrodesBoston Scientific recalls CSK Electrodes over potential performance issues.
4 products
FDA•LOWPrimidone 50 mg TabletsAmneal Pharmaceuticals is recalling Primidone 50 mg tablets due to potential cross-contamination with Acemetacin API.
FDA•MODERATEMinocycline Hydrochloride 115 mg TabletsAscend Laboratories is recalling Minocycline Hydrochloride 115 mg tablets due to failed dissolution specifications.
- Food RecallFDA•MODERATENeuro Nourish Dietary Supplement
Sensory Supplement is recalling Neuro Nourish dietary supplement due to premature lipid oxidation causing off odors and bitter taste.
3 products 
FDA•MODERATEZep Alcohol Sanitizer SprayZep Inc. is recalling 55-gallon containers of Alcohol Sanitizer Spray due to potential microbial contamination.
FDA•MODERATEAdvance Aluminum Chloride Gel Hemostatic KitInter-Med is recalling Aluminum Chloride Gel kits due to an incorrect package insert that provides dangerous first aid instructions.
FDA•MODERATEHintermann Series Talar ImplantDT MedTech is recalling the Hintermann Series Talar Implant due to a labeling error that may result in the wrong implant being used.
FDA•MODERATESiemens Dimension Tacrolimus Flex Reagent CartridgeSiemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.
FDA•MODERATEPark St. Deli Macaroni & CheesePark St. Deli Macaroni & Cheese is recalled due to an undeclared soy lecithin allergen.
FDA•CRITICALBeekeeper's Naturals Saline Nasal SprayBeekeeper's Naturals is recalling 1 FL OZ Saline Nasal Spray bottles due to potential microbial contamination.
2 products
FDA•MODERATEFarm Rich Pizza Cheese CrunchersRich Products Corp is recalling Farm Rich Pizza Cheese Crunchers due to potential metal contamination.
FDA•MODERATEMedartis APTUS Cannulated Compression ScrewsMedartis is recalling APTUS cannulated compression screws due to a manufacturing defect where the cannulation is not centered.
FDA•MODERATEEXENT AnalyserThe Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.
FDA•MODERATEBudesonide Inhalation SuspensionSun Pharmaceutical is recalling Budesonide Inhalation Suspension (1mg/2mL) due to the presence of foreign black or brown particles.
FDA•MODERATEBreckenridge Pharmaceutical: multiple capsulesBreckenridge recalls Duloxetine capsules over N-nitroso-duloxetine impurity above FDA limit.
2 products