FDA•MODERATE
Glycopyrrolate Oral Solution 1 mg/5 mL
Precision Dose recalls Glycopyrrolate Oral Solution 1 mg/5 mL over an impurity.
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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.
FDA•MODERATESafeOp Patient InterfaceAlphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.
FDA•MODERATEMan Fon: 2 Wonton WrappersMan Fon recalls Won Ton Wrappers Extra Thin over undeclared Yellow #5 and #6 colors.
2 products
FDA•MODERATESnapshotGLO Wound Imaging DeviceKent Imaging recalls SnapshotGLO wound imaging devices due to battery charging failure.
FDA•MODERATEPipeline Flex Embolization DeviceMicro Therapeutics recalls Pipeline Flex Embolization Devices due to incorrect labeling of implant sizes.
4 products
FDA•MODERATEHalyard Standard Line Insertion PackAVID Medical recalls Halyard Standard Line Insertion Pack (Model PVHM234-01) over silicone seal defects causing leakage.
- Device RecallFDA•MODERATEEmano Flow v2.0.0
Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.
FDA•MODERATETheraSphere 360 Y-90 Management PlatformBoston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
FDA•MODERATEOlympus High Flow Insufflation Unit UHI-4Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.
FDA•MODERATEVentriculostomy KitMedtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.
FDA•MODERATEPenumbra RED 68 Reperfusion CatheterPenumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.
FDA•MODERATEWilcox BOSS Xe Aiming LasersWilcox is recalling all BOSS Xe aiming lasers to implement a safety-related software enhancement.
- Device RecallFDA•MODERATE3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
FDA•MODERATESilent Nite Sleep ApplianceThe Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•CRITICALCetirizine Hydrochloride Tablets 5 mgRising Pharma recalls Cetirizine HCl 5 mg tablets due to ranitidine cross-contamination.
CPSC•Cat & Jack Children's SandalsCat & Jack children's sandals are recalled due to a choking hazard from detachable pearls on the footwear.
FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgMajor Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
FDA•LOWTrokendi XR Topiramate ER Capsules 25mgSupernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products
FDA•MODERATEDivalproex Sodium Delayed-Release Tablets 500 mgBionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
CPSC•Currey & Company Nottaway ChandeliersCurrey & Company is recalling Nottaway chandeliers due to an electrocution hazard caused by a lack of proper electrical grounding.
CPSC•Hollis 200LX Diving RegulatorsHollis 200LX diving regulators are recalled due to a risk of drowning from potential inlet tube breakage.
CPSC•Jobon Torch LightersJobon torch lighters are recalled for lacking child-resistant mechanisms, posing fire and burn hazards to users.
CPSC•Liizousuda Paint ThinnerLiizousuda paint thinner is recalled because its non-child-resistant packaging poses a poisoning and chemical pneumonia risk to children.
CPSC•Madewell Women's SweatersMadewell is recalling women's sweaters due to a violation of federal clothing textile standards, posing a serious burn and injury risk.
CPSC•Noerishia Adult Portable Bed RailsNoerishia adult portable bed rails are recalled due to a serious entrapment and asphyxiation hazard.
CPSC•Oitnlaughter LED Finger Light ToysOitnlaughter LED finger lights are recalled due to a battery ingestion hazard that can cause serious injury or death.
CPSC•Panasonic Electric Toaster OvensPanasonic is recalling model NB-G200 electric toaster ovens due to shock and fire hazards from insufficient power cord insulation.
CPSC•Boon PIVOT Toddler Tower Step StoolsBoon PIVOT toddler tower step stools are being recalled due to tip-over and fall hazards that pose a risk of serious injury or death.
CPSC•Wade Logan Annyka 9-Drawer Fabric DressersWade Logan 9-drawer fabric dressers are recalled due to tip-over and entrapment hazards that violate federal safety standards.
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor gain causing inaccurate output.
3 products
FDA•MODERATEMedline Total Knee Pack Mixing Bowls and SpatulasMedline recalls Total Knee Pack kits with Zimmer Biomet mixing bowls and spatulas over sterility risk.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material with trace blood.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic is recalling replacement brush heads over a choking hazard from breakage.
2 products
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.