Device Recall
FDA•MODERATE
Portrait Core Services Software V1.1
GE Medical recalls Portrait Core Services Software V1.1 over possible loss of patient monitoring and alarm reset issues.
4 productsFilters
Category
Agency
Severity
Date
Distributed in
All Recalls
Back to home ←
FDA•Feline Milk ReplacerRevival Animal Health recalls feline milk replacers over low nutrient levels.
FDA•MODERATERamipril Capsules USP 10 mgHikma recalls Ramipril Capsules USP 10 mg over a failed impurity (DCU) specification.
FDA•MODERATEICU Medical IV Sets with Drip ChambersICU Medical recalls IV sets with drip chambers due to black specks that may delay therapy.
FDA•LOWAfricando Alfredo Hot SauceAfricando Alfredo Hot Sauce recalled for undeclared wheat and soy allergens.
FDA•MODERATEByron White Formulas: 3 May Contain Nuts CasByron White Formulas recalls A-L Complex, A-FNG, and A-P herbal supplements due to undeclared walnuts.
3 products
FDA•MODERATEOlympus PowerSeal 5 mm Curved Jaw Sealer & DividerOlympus recalls PowerSeal 5 mm Curved Jaw Sealer & Divider over labeling error.
FDA•MODERATEZicam Medicated Nasal SwabsZicam nasal swabs recalled over microbiological testing failures.
FDA•MODERATEIMRIS ORT200 Operating Room TableIMRIS recalls ORT200 operating room tables due to actuator/lock failure risk of unintended movement.
2 products
FDA•MODERATEActhar Gel (Repository Corticotropin Injection) 5 mL VialsMallinckrodt recalls Acthar Gel 5 mL vials over glass and stopper particulate.
2 products
FDA•MODERATEClobetasol Propionate Cream USP, 0.05%Lupin recalls Clobetasol Propionate Cream 0.05% due to failed content uniformity.
FDA•MODERATEhealthmark ProChek-II TestHealthmark recalls ProChek-II tests (PT-313, PT-201-12) over expired ingredient risk.
2 products- Device RecallFDA•MODERATEFUJIFILM Synapse PACS Software
FUJIFILM Synapse PACS v7.4.310 recalled due to inaccurate ruler measurements.
FDA•MODERATEMedline Femoral Pack and FEVAR KitsMedline recalls Femoral Pack and FEVAR kits due to potentially contaminated component.
14 products
FDA•MODERATEGENESYS CrossFT Suture AnchorConMed recalls GENESYS CrossFT Suture Anchor (REF CFBC-5502B) due to incorrect implant card.
FDA•MODERATEFresenius 2008T BlueStar Hemodialysis MachineFresenius recalls 2008T BlueStar Hemodialysis Machine over flow, no water, and temperature alarms.
FDA•Baxter 0.9% Sodium Chloride Injection 500 mLBaxter recalls 0.9% Sodium Chloride Injection 500 mL VIAFLEX bags over fiberglass particulate contamination.
FDA•LOWIbuprofen Oral Suspension SyringesSafecor recalls Ibuprofen oral suspension syringes over cross-contamination risk.
FDA•MODERATEStructur 2 SC Temporary Resin Cartridge RefillHenry Schein recalls Structur 2 SC Temporary Resin Cartridge Refill 75Gm due to incorrect packaging and IFU.
2 products
FDA•MODERATEMidmark IQecg Digital ECGMidmark recalls IQecg Digital ECG over incorrect ECG waveforms and BPM calculations.
2 products
FDA•MODERATECanon Alphenix Ceiling Movement Gear ScrewsCanon recalls Alphenix X-ray systems (INFX-8000C/F/V) over loose ceiling gear screws.
FDA•MODERATERemedy+ Recovery Dogswell Pet WormerRemedy+ Recovery Dogswell Pet Wormer recalled due to adverse event complaints.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgAccord recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEHalyard Davinci TruCustom Foley TrayHalyard Davinci TruCustom Foley tray recalled over missing latex warning on StatLock component.
8 products
FDA•MODERATEMerge PACS and Merge OrthoPACSMerge PACS and OrthoPACS recalled due to inaccurate measurement display.
FDA•MODERATEAmerican Contract System Convenience KitAmerican Contract Systems recalls Convenience Kit CV B PACK (TNCB10AM) due to catheter performance failure.
4 products- Device RecallFDA•MODERATEPhilips Incisive CT Software
Philips Incisive CT software V4.5/V5.0 recalled for Bolus Tracking scan trigger failure.
FDA•MODERATEMedline Trach Tube KitMedline recalls Trach Tube Kit (SKU DYKM2330) over labeling discrepancy.
FDA•MODERATEOnli Hydrophilic Urethral Intermittent CathetersHollister recalls Onli intermittent catheters due to a protrusion defect that may cause genitourinary trauma or bleeding.
2 products
FDA•MODERATEMedline ENT Convenience KitsMedline recalls ENT/sinus kits with Pilling Wecksorb Neurosponges over endotoxin risk.
6 products
FDA•MODERATEDouble Golden Fish Galanga PowderTang's Family recalls Double Golden Fish Galanga Powder due to elevated lead levels.
FDA•MODERATEAmerican Contract Systems Procedure KitsAmerican Contract Systems recalls 9 procedure kits due to potential endotoxin variability in included neurological sponges.
3 products
FDA•MODERATEPrince Bakery: 4 Enriched Bleached FloursPrince Bakery recalls Italian and French breads over undeclared sesame in the ingredient statement.
4 products
FDA•Glutathione 200 mg/mL Sterile Multidose VialsOptimal Balance Pharmacy recalls Glutathione 200 mg/mL vials over bacterial endotoxin contamination.
FDA•MODERATEGifford's Power Play Fudge Ice CreamGifford's recalls Power Play Fudge ice cream (1 qt) over possible rubber pieces.
FDA•MODERATECarbamazepine Tablets 200mgGSMS recalls Carbamazepine 200mg tablets over black specks.
FDA•MODERATEAcamprosate Calcium 333 mg TabletsMylan recalls Acamprosate Calcium 333 mg tablets over dissolution failure.
FDA•MODERATEEsteem Body Soft Convex Urostomy PouchConvaTec recalls Esteem Body Soft Convex Urostomy Pouches due to cap leakage risk.
FDA•MODERATEWhole BloodSuncoast Communities Blood Bank recalls whole blood due to incomplete donor eligibility screening.
2 products
FDA•MODERATEVeritas Standard Glenoid Baseplaterestor3d recalls Veritas Standard Glenoid Baseplate over screw hole machining defect.
2 products
FDA•MODERATEOutshine Fruit Bar: 6 productsDreyer's recalls Outshine Fruit Bars over possible glass pieces.
6 products
FDA•MODERATEProlon Everyday Apulian Almond & Cocoa SpreadProlon Apulian Almond & Cocoa Spread recalled for undeclared tree nuts (hazelnut, cashew, pistachio).
FDA•MODERATECarbamazepine Tablets 200mgTaro recalls Carbamazepine 200mg tablets over black specks.
2 products
FDA•MODERATERed Blood Cells, Leukocytes ReducedOneBlood recalls Red Blood Cells, Leukocytes Reduced from a misregistered donor.
FDA•MODERATEMedtronic MiniMed 640G Insulin PumpMedtronic recalls loaner MiniMed 640G pumps (MMT-1711/1712) over cleaning damage risk.
3 products
FDA•MODERATEFDI Automated Field Steam SterilizerFDI recalls Automated Field Steam Sterilizer over possible ground continuity loss in the water recovery system connector.
FDA•MODERATESyva EMIT 2000 Quinidine AssaySiemens recalls Syva EMIT 2000 Quinidine Assay over precision issues that may cause elevated readings and risk of cardiac arrhythmias.
2 products- Device RecallFDA•MODERATEBeckman Coulter DxC 500i Analyzer Modules
Beckman Coulter recalls DxC 500i Analyzer Modules (software ≤1.5) over a Parameter Package import defect that can yield erroneous results.
2 products 
FDA•MODERATELago XSpectral Instruments recalls Lago X over a missing "X-Ray On" banner during readiness check.
2 products
FDA•MODERATEProtein Cereal Cocoa CrunchProtein Cereal Cocoa Crunch recalled over undeclared soy allergen.