FDA•MODERATE
GE MAC 5 A4 and A5 Resting ECG Analysis Systems
GE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
Filters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
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•MODERATEStandard Pasteurized Donor Human MilkUC Health Milk Bank recalls donor human milk bottles over possible plastic particle contamination.
FDA•MODERATELidocaine HCl Injection USPSpectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
FDA•MODERATELunds & Byerly's Curry Powder SweetLunds & Byerly's Curry Powder Sweet is recalled due to undeclared sesame seeds in the product.
- 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 recalls Arvis Hip & Knee 3.0 Instrument Set over magnet face wear/corrosion.
2 products
FDA•MODERATEShimadzu X-Ray Systems High Voltage GeneratorShimadzu recalls X-ray systems over generator contactor weld risk; full model list on FDA page.
2 products
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•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 BreadMotor City Pizza Co. 5 Cheese Bread recalled over 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 
FDA•MODERATECovidien Mon-a-Therm Esophageal StethoscopeCovidien recalls Mon-a-Therm Esophageal Stethoscope 400TM (REF 90042) due to lack of FDA clearance.
3 products
FDA•MODERATEExacta Mix Vented Micro-Volume InletBaxter is recalling Exacta Mix Vented Micro-Volume Inlet (Model H938175) due to incorrect filters that may cause flow and clinical issues.
FDA•MODERATECovidien Shiley Tracheostomy TubeCovidien is recalling Shiley Tracheostomy Tubes due to incorrect display box labeling.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FDA•MODERATEGE HealthCare CARESCAPE Telemetry ServerGE HealthCare recalls CARESCAPE Telemetry Server V5 ATO over potential loss of ECG and SpO2 monitoring.
6 products
FDA•MODERATEMedtronic 1x4 Pocket Adaptor KitMedtronic recalls 1x4 Pocket Adaptor Kit (Model 64001) due to incorrect Use-By-Dates.
2 products
FDA•MODERATEMedline Eye Tray-LF Convenience KitMedline is recalling Eye Tray-LF kits containing mislabeled Cardinal Health syringes that may lead to incorrect insulin dosing.
FDA•MODERATEPhilips Azurion System HDDPhilips recalls Azurion systems over aging HDDs that may cause loss of imaging or movement.
3 products
FDA•LOWPred Mild Ophthalmic SuspensionAbbVie is recalling 10 mL bottles of Pred Mild ophthalmic suspension due to failed stability specifications.
FDA•MODERATEHydroMARK Breast Biopsy Site MarkerDevicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.
FDA•MODERATEDexcom G7 Continuous Glucose Monitoring SystemDexcom is recalling stolen G7 sensors that were meant for destruction, posing risks of infection, sensor failure, and inaccurate readings.
FDA•LOWNicotine Transdermal System Patch 14 mgAveva is recalling 14 mg Nicotine Transdermal System Patches due to elevated levels of oxidative-related impurities.
FDA•MODERATEToxiBan Charcoal-Kaolin SuspensionLloyd is recalling ToxiBan Charcoal-Kaolin Suspension for domestic animals due to microbial levels exceeding specification limits.
FDA•MODERATEHalyard Purezero Ultraviolet Nitrile Exam GlovesHalyard is recalling Purezero Ultraviolet Nitrile Exam Gloves due to a failure to meet chemical permeation performance specifications.
FDA•MODERATEFentanyl Citrate Sterile CADD for InjectionIntegraDose is recalling Fentanyl Citrate Sterile CADD for Injection (NDC 71139-6030-1) due to the product being subpotent.
FDA•MODERATENephronex Vitamin B-Complex, Vitamin C & Folic Acid LiquidSafecor Health is recalling Nephronex dietary supplement liquid due to the presence of foreign black particles.
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemsPhilips is recalling various Azurion systems due to potential mechanical wear in the Float Tabletop control module affecting table movement.
2 products
FDA•MODERATEPhilips Azurion X-ray Tube Cooling Unit Deaeration HosePhilips recalls Azurion systems: deaeration hose may leak oil, causing cooling failure and low-dose fluoroscopy lockout.
4 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•MODERATEEstradiol Gel 0.1%ANI Pharmaceuticals is recalling Estradiol Gel 0.1% due to defective packets that may be empty or partially full.
FDA•MODERATECimzia Prefilled SyringesUCB is recalling Cimzia prefilled syringes and starter kits due to a lack of assurance of sterility.
FDA•MODERATEErythromycin Tablets 250 mgZydus recalls Erythromycin 250 mg tablets due to impurity above acceptable limit.
2 products
FDA•MODERATEGlobus Medical OneLIF Integrated FixationGlobus Medical is recalling OneLIF integrated fixation systems because some units may not meet shelf-life specifications, which could affect product performance.
2 products
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic recalls GUNDRY Retrograde Cannula over sterile barrier breach risk.
9 products
FDA•MODERATEVitamin B-Complex, Vitamin C & Folic Acid SupplementLlorens Pharmaceuticals is recalling Vitamin B-Complex, Vitamin C & Folic Acid supplement bottles due to foreign black particulate matter.
FDA•MODERATEAllProvide Gently Cooked Chicken Recipe for DogsAllProvide is recalling 16 oz Gently Cooked Chicken Recipe for Dogs due to potential plastic contamination.
FDA•MODERATEGas-X Simethicone 125 mg SoftGelsHaleon is recalling Gas-X Simethicone 125 mg SoftGels (120 count), UPC 3 00674 35041 9, due to incomplete inactive ingredient labeling.
FDA•MODERATEWellnov Supplements: 14 Vitaminally LLC Chandler AzesWellnov recalls liquid multivitamins and supplements over cGMP deviations risking bacterial contamination and C. botulinum.
14 products
FDA•MODERATELiraglutide InjectionLupin is recalling Liraglutide Injection (NDC 70748-346-02 and 70748-346-03) due to white thread-like particulate matter in the cartridge.
FDA•MODERATEAtomoxetine HCl CapsulesSafecor Health is recalling Atomoxetine HCl capsules due to a labeling mix-up that may result in patients receiving an incorrect dosage.