FDA•MODERATE
EXENT Analyser
The Binding Site is recalling the EXENT Analyser due to a software error that may cause inaccurate M-protein detection or measurements.
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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
FDA•MODERATENeoSpan SuperElastic Compression StapleIn2bones USA is recalling 10+ variants of NeoSpan compression staples due to missing MR Conditional safety labeling.
2 products
FDA•CRITICALCareFusion 213: Multiple Chlorhexidine Gluconate ProductsCareFusion recalls BD ChloraPrep Clear and FREPP Clear applicators over sterility concerns from lidding wrinkles.
4 products
FDA•MODERATECareFusion 213: Multiple Subsidiary Of Beckton ProductsCareFusion recalls BD ChloraPrep and PurPrep applicators over sterility concerns.
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•CRITICALDoxorubicin Hydrochloride Liposome InjectionNorthstar Rx is recalling Doxorubicin Hydrochloride Liposome injection 50 mg/25 mL vials due to potential glass particulate contamination.
FDA•MODERATECORFLO Safety PEG KitAvanos recalls CORFLO Safety PEG Kit model 30-4320 due to supplier quality issues with lidocaine injection.
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•MODERATEAllia IGS 3 Pulse angiographic X-ray systemGE HealthCare 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 (40001-0401) over soft limit alert failure that may cause under- or over-delivery.
3 products
FDA•MODERATETDC VELOCE 23G Two Dimensional CutterD.O.R.C. recalls TDC VELOCE 23G cutter over loose outer knife complaints.
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 spore testing service recalled due to incorrect incubation process.
4 products
FDA•CRITICALHaleon US: multiple drugsHaleon is recalling Gas-X Extra Strength softgels in 72-count and 120-count packages due to potential chemical contamination.
2 products
FDA•CRITICALThe Coffee Connexion Co: 4 productsCoffee Connexion recalls cheese sauce mixes due to potential Salmonella from supplier's 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 over metallic particles in chewable tablets.
23 products
FDA•MODERATEXyvona (levorphanol tartrate) 2mg TabletsForte BioPharma recalls Xyvona 2mg tablets over FDA name denial.
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•MODERATEDuloxetine DR Capsules 30 mgAsclemed USA is recalling Duloxetine DR Capsules 30 mg due to the presence of a nitrosamine impurity above acceptable intake limits.
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 due to fingerprint scanner overheating risk of first-degree 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•CRITICALSpinal Needle Procedure KitsB. Braun recalls spinal needle kits 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.
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, due to failed dissolution specifications.
FDA•MODERATEArvis Hip & Knee 3.0 Instrument SetKico Knee recalls Arvis Hip & Knee 3.0 Instrument Set due to wear/corrosion on magnet face of V-Block and Trackers.
2 products
FDA•MODERATEShimadzu X-Ray and Angiography SystemsShimadzu is recalling 20+ models of X-ray and angiography systems due to a power-off failure caused by welding electromagnetic contactors.
2 products
FDA•MODERATEPhaseOne Antimicrobial Solution SprayerOculus Technologies is recalling PhaseOne Antimicrobial Solution due to sprayer spring corrosion that may contaminate the product.
FDA•MODERATECASE v7.0 Cardiac Testing SystemGE Medical is recalling the CASE v7.0 Cardiac Testing System due to a risk of electrical sparking at the printer head.
FDA•MODERATEHiRes Ultra 3D CI HiFocus Mid Scala Cochlear ImplantAdvanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.
2 products
FDA•MODERATENeptune Smart Docking StationStryker is recalling the Neptune Smart Docking Station (120V) due to missing safety testing and a potential electrical shock risk.
FDA•MODERATECovidien EndoStitch Polysorb Single Use Loading UnitCovidien is recalling EndoStitch Polysorb loading units (170053, 170071) due to packaging holes that may compromise sterility.
FDA•MODERATEMotor City Pizza Co. 5 Cheese BreadChampion Foods is recalling Motor City Pizza Co. 5 Cheese Bread due to potential Salmonella contamination.
FDA•LOWLidocaine HCl Injection 2%Eugia US LLC is recalling Lidocaine HCl Injection 2% because the label wrap covers the barcode, making it difficult to scan.
- Device RecallFDA•MODERATEB. Braun CESK Northside Anesthesia Tray
B. Braun recalls CESK Northside Anesthesia Tray due to cracked adhesive tubing.
8 products