Device Recall
FDA•MODERATE
Merlin 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.
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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 reusable electrodes over performance concerns.
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.
FDA•MODERATENeuro Nourish Dietary SupplementSensory 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•MODERATEDragonfly Thai Ginger PowderDragonfly Thai Ginger Powder is being recalled due to potential lead contamination.
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 recalls Saline Nasal Spray due to microbial contamination.
2 products
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 30mg and 60mg capsules due to N-nitroso-duloxetine impurity above FDA limit.
2 products
FDA•CRITICALCareFusion 213: Multiple Chlorhexidine Gluconate SolutionsBD recalls ChloraPrep Clear and FREPP Clear applicators due to sterility seal breach risk.
4 products
FDA•MODERATECareFusion 213: Multiple Subsidiary Of Beckton SolutionsBD recalls ChloraPrep & PurPrep applicators due to lack of sterility assurance, posing infection risk.
10 products
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
FDA•MODERATEMicromed SD LTM 64 PLUS EEG AmplifierMicromed is recalling SD LTM 64 PLUS EEG amplifiers due to a potential one-second temporal delay that may cause misinterpretation of results.
FDA•MODERATECGuard Prime Carotid Stent SystemInspireMD recalls CGuard Prime Carotid Stent System (model CND0830) due to deployment complications.
6 products
FDA•MODERATECORFLO Safety PEG KitAvanos recalls CORFLO Safety PEG Kit (model 30-4320) due to supplier-recalled lidocaine.
20 products
FDA•MODERATEMahurkar Elite PASS TraysMozarc Medical is recalling Mahurkar Elite PASS Trays because the Tegaderm CHG dressing is missing from the packaging.
2 products
FDA•MODERATEGE Allia IGS 3 Pulse Angiographic X-ray SystemGE recalls Allia IGS 3 Pulse X-ray systems over electrical shock risk to service personnel.
5 products
FDA•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a luer-lock leak issue that poses a slip and fall hazard.
FDA•MODERATEPlum Solo Precision IV PumpICU Medical recalls Plum Solo IV Pump over soft limit alert failure.
3 products
FDA•MODERATETDC VELOCE 23G Two Dimensional CutterD.O.R.C. recalls TDC VELOCE 23G cutter over loose outer knife risk.
3 products
FDA•MODERATEEXCOR Pediatric VAD Blood Pump PU ValvesBerlin Heart is recalling EXCOR Pediatric VAD Blood Pump PU Valves due to an expiration date mismatch that could delay surgical procedures.
FDA•MODERATESporeTraq Mail-In Spore Testing ServiceSporeTraq Mail-In Spore Testing Service recalled due to incorrect incubation process; model 1023780.
4 products
FDA•CRITICALHaleon US: multiple softgelsHaleon recalls Gas-X Extra Strength softgels (120 & 72 ct) over possible coolant contamination.
2 products
FDA•CRITICALThe Coffee Connexion: 4 Poly Bag And PackedsCheese sauce mixes and related products recalled over potential Salmonella from dry milk powder.
4 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling Sharpoint microsurgical knives mislabeled as 2.2mm when they are actually 3.0mm.
FDA•CRITICALKayserBett IDA Pediatric Care BedKayserBett is recalling the IDA pediatric care bed due to an entrapment risk if the hand control is not locked while the child is unattended.
FDA•MODERATEGrace Medical Stapes ProsthesisGrace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
FDA•MODERATEDa Vinci 5 NIR Handheld CameraIntuitive Surgical is recalling the da Vinci 5 NIR handheld camera system due to a risk of unintentional illumination activation.
2 products
FDA•MODERATENiacin Extended-release Tablets 1,000 mgLannett is recalling Niacin Extended-release Tablets 1,000 mg due to failed dissolution specifications.
FDA•MODERATEKirkland Signature Ultra Strength AntacidKirkland Signature antacid recalled due to metallic particles in tablets.
23 products
FDA•MODERATEXyvona (levorphanol tartrate) 2mg TabletsForte BioPharma recalls Xyvona (levorphanol tartrate) 2mg tablets due to FDA denial of proprietary name.
2 products
FDA•MODERATEDeRoyal Covaderm Plus Vascular Access DressingDeRoyal is recalling Covaderm Plus Vascular Access Dressing (Ref 46-406) due to a lack of sterility assurance.
FDA•MODERATEAligned Medical Fluids KitWindstone Medical Packaging is recalling Aligned Medical AMS16835 Fluids Kits due to a supplier recall of the included Lidocaine injection.
- Device RecallFDA•CRITICALIvenix Infusion System LVP Software
Fresenius Kabi is recalling Ivenix Infusion System LVP software due to a potential battery-health reporting error that may cause pump shutdown.
FDA•MODERATEGE MAC 5 A4 and A5 Resting ECG Analysis SystemsGE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
FDA•MODERATEBD Pyxis MedStation 4000 Fingerprint ScannerBD Pyxis MedStation 4000 recalled: fingerprint scanner may overheat, causing burns.
8 products
FDA•MODERATEMedrad Avanta Injection System Tube SetsBayer is recalling Avanta Multi-Patient Administration Tube Sets due to a fit issue that may cause connection instability during use.
FDA•CRITICALPencan Spinal Needle TraysB. Braun recalls Pencan spinal needle trays over potential quality issues with bupivacaine component.
6 products
FDA•CRITICALDried Herring FishPrime Food is recalling 7 oz. Dried Herring Fish due to potential Clostridium botulinum contamination from improper evisceration.
FDA•MODERATELidocaine HCl Injection USPSpectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
- Food RecallFDA•MODERATEAlbertsons: multiple undeclared allergens
121 Albertsons products recalled for undeclared tree nuts, fish, or shellfish.
121 products 
FDA•LOWYunker Energy & Health Herbal SupplementSato Pharmaceutical is recalling Yunker Energy & Health Herbal Supplement due to a failure to meet label claims for Vitamin E content.