FDA•MODERATE
Medtronic EOPA Arterial Cannula 22FR
Medtronic recalls EOPA 22FR arterial cannula (Model 77422) over pinhole leak risk during bypass.
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FDA•MODERATELidl US TRADING: 2 productsLidl recalls Eridanous Greek Style Shortbread Cookies due to undeclared allergens (wheat, soy, milk, eggs, coconut).
2 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•MODERATEProin ER TabletsPegasus recalls Proin ER 145 mg dog tablets over failed dissolution specs.
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•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 Pediatric Open Heart KitMedline is recalling convenience kits containing BD PurPrep 26 mL over possible Bacillus contamination.
4 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.
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•MODERATEAXP Processing Bag SetThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.
FDA•MODERATEPeter Rabbit Organics Banana & Strawberry Fruit PureePT Organics recalls Peter Rabbit Organics Banana & Strawberry puree pouches due to possible plastic strands.
2 products
FDA•MODERATEBrooklyn Roasting Cold Brew ConcentrateBrooklyn Roasting recalls cold brew concentrate 2.5gal over possible botulism risk.
FDA•MODERATEVentriculostomy KitMedtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.
FDA•LOWShandong Ling Xian Food: 6 Serve Hot Or Cold IngredientsIsland Pacific and Nautilus imitation crab sticks and flakes recalled for undeclared STTP.
6 products
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•LOWLidolog KitLidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
2 products
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•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•MODERATEVintage Roots Root Beer SyrupVintage Roots Root Beer Syrup recalled over unapproved sassafras bark additive.
- FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate Capsules
Ascend 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•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and FARAPOINT CatheterBoston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.
3 products
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedLifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products