FDA•MODERATE
HardyDisk Cefiderocol 30µg Susceptibility Disks
Hardy Diagnostics recalls HardyDisk Cefiderocol 30µg disks due to incorrect cartridges that may cause false susceptibility results.
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FDA•MODERATEU2 Total Knee System PSA Box TrialUnited Orthopedic recalls U2 Total Knee PSA Box Trials (models 9323-5511 thru 9323-5526) due to screw defect.
4 products
FDA•CRITICALKC Everyday Mac & CheeseKerry recalls KC Everyday Mac & Cheese over undeclared egg allergen.
FDA•MODERATEDicyclomine Hydrochloride Capsules 10mgAurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.
FDA•MODERATEGE Portrait Core Services Software V1.2.0GE recalls Portrait Core Services SW V1.2.0 over a security vulnerability.
2 products
FDA•MODERATEFilmArray NGDS Warrior PanelBiofire Defense recalls FilmArray NGDS Warrior Panel due to strain mismatches affecting test accuracy.
FDA•MODERATEGE MAC VU360 ElectrocardiographGE recalls MAC VU360 ECG over software issue that may mix patient data.
FDA•MODERATEMerge PACS Medical Imaging WorkstationMerge PACS workstation recalled over risk of displaying thumbnails from a prior patient study.
2 products
FDA•LOWSyva Emit Tox Tricyclic Antidepressant Calibrator/ControlsSiemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
FDA•LOWSyva Emit Disopyramide AssaySiemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.
FDA•MODERATEMaquet Flow Anesthesia Machine VaporizerMaquet recalls Flow anesthesia machines over risk of insufficient anesthesia.
FDA•MODERATEStryker AHTO Tube Set PackagingStryker recalls AHTO Tube Set Packaging (Cat. 0250070600) over handpiece leaking.
5 products
FDA•MODERATEDialysis Change Tray Clear SequenceMedical Action recalls Dialysis Change Tray Clear Sequence (Model 78791) due to improper seal in needle-free access device.
FDA•MODERATEOXOS MC2 Portable X-Ray SystemOXOS Medical recalls MC2 Portable X-Ray System due to overheating circuit board.
2 products
FDA•MODERATEVector Pedicle Screw System Anti-TorqueInnovasis recalls Vector Pedicle Screw System anti-torque instrument (LS-749) due to undersized tip that may prevent engagement during surgery.
FDA•CRITICALOptiray 350 Ioversol InjectionLiebel-Flarsheim recalls Optiray 350 Ioversol Injection 500 mL vials due to particulate matter (plastic, steel, glass).
2 products
FDA•CRITICALHalyard Cardiac Cath Pack with Medline ManifoldAVID Medical recalls Halyard kits with Medline manifolds due to particulate risk.
3 products
FDA•MODERATEmunevo DRIVE Powered Wheelchair Control SystemMunevo recalls wheelchair control systems over software calibration issue causing steering drift and collision risk.
- Device RecallFDA•MODERATEWASPLab WebApp Software
Copan WASP recalls WASPLab WebApp software over a result-overwrite issue.
FDA•MODERATERadial Jaw 4 Biopsy ForcepsBoston Scientific recalls Radial Jaw 4 biopsy forceps due to sterile barrier breach risk.
4 products
FDA•MODERATEFORWARD Oral Airway KitIntegrated Medcraft recalls FORWARD Oral Airway Kits due to possible occluded airway tip.
2 products- Device RecallFDA•MODERATEQuantum 4Front 2 Wheelchair Controller
Quantum Rehab recalls the Quantum 4Front 2 wheelchair controller over a software issue that can cause unexpected park brake stops.
13 products 
FDA•MODERATETherabody Theragun G4 PRO ChargerTherabody recalls Theragun G4 PRO charger due to fire risk from overheating cradle.
FDA•CRITICALBD Needle Kit for Powered DriverBard Access recalls BD Powered Driver Needle Kits over obturator removal difficulty.
FDA•MODERATEPower Over Fiber Base ModuleTerex Utilities recalls Power Over Fiber Base Module due to missing laser certification and improper labeling.
FDA•CRITICALAquafaba Powder529 Commerce recalls Aquafaba Powder over undeclared egg allergen.
FDA•MODERATEStryker Hoffmann II Connecting Rod Micro 3 x 30mmStryker recalls Hoffmann II Connecting Rod Micro 3 x 30mm due to potential cracking after cleaning and sterilization.
7 products
FDA•MODERATEGEM Premier 5000/7000 Bar Code Reader WandInstrumentation Laboratory recalls BCR Wand for GEM Premier 5000/7000 analyzers; may assign results to wrong patient ID.
10 products
FDA•MODERATEAzelaic Acid Gel 15%Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.
FDA•MODERATEMellish Island Super Skin Dietary SupplementMellish Island Super Skin supplement recalled for undeclared fish allergen in marine collagen.
FDA•MODERATEOsteoBallast 45 x 17.5 mmIsoTis recalls OsteoBallast 45 x 17.5 mm DBM mesh due to underfill, risking incomplete fusion.
FDA•CRITICALResmed Astral 100/150 VentilatorResMed recalls Astral 100/150 ventilators due to supercapacitor leakage that may interrupt ventilation.
FDA•MODERATEPhilips Brilliance CT ScannersPhilips recalls Brilliance CT scanners over possible scan trigger failure, risking patient rescan and extra radiation.
3 products
FDA•MODERATEAMS Spinal KitAMS SPINAL KIT recalled due to supplier quality issues with included Lidocaine HCl injection.
9 products
FDA•MODERATEMedtronic EOPA Arterial Cannula 22FRMedtronic recalls EOPA 22FR arterial cannula (Model 77422) over pinhole leak risk during bypass.
6 products
FDA•CRITICALRelax 5-HTP Plus Vitamin B6Relax 5-HTP Plus Vitamin B6 recalled for elevated 5-HTP levels above allowed dosage.
2 products
FDA•CRITICALCefazolin in Dextrose InjectionBaxter recalls Cefazolin in Dextrose 2g/100mL infusion bags due to particulate matter.
FDA•CRITICALAmerican Regent: Multiple Packaged In InjectionsAmerican Regent recalls Nitroglycerin Injection 50 mg/10 mL and other injectables due to particulate matter (hair).
14 products
FDA•MODERATEDorzolamide HCl and Timolol Maleate Ophthalmic SolutionMicro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
6 products
FDA•MODERATEMycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for Injection 500 mg/vial due to precipitate.
2 products
FDA•MODERATEArgon L-Cath PICC CathetersArgon recalls L-Cath PICC catheters over hub leak/crack risk.
2 products
FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls AMS medical convenience kits due to potential endotoxin variability in included sponges.
6 products
FDA•CRITICALMIDWEST POULTRY SERVC C/O H &: 4 productsSimple Truth Cage Free eggs recalled due to possible Salmonella Enteritidis.
4 products
FDA•MODERATEFresenius Kabi: Multiple Rx Only InjectionsFresenius Kabi recalls injectables due to hair particulate matter.
5 products
FDA•MODERATERohto-Mentholatum: Multiple Rohto Cooling Eye DropsRohto Cooling Eye Drops recalled over sterility concerns; multiple formulations affected.
8 products
FDA•MODERATEGlycopyrrolate Oral Solution 1 mg/5 mLPrecision Dose recalls Glycopyrrolate Oral Solution 1 mg/5 mL over an impurity.
3 products
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters (sizes 16, 18, 20) due to surface raw material risk.
9 products
FDA•MODERATEMiniMed Go AppMedtronic MiniMed recalls MiniMed Go App v1.0.0 and v1.1.0 over nighttime alert failure risking missed insulin doses.
FDA•MODERATEFlexible Hystero-Fiberscope KitsKarl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.