FDA•
Fundamental Feed: 3 products
Fundamental Feed recalls three horse feed pellet products over elevated aflatoxin levels.
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FDA•MODERATEEXO Black Tattoo InkXtreme Inks recalls EXO Black tattoo ink due to Pseudomonas aeruginosa contamination.
FDA•MODERATEPhilips Brilliance CT SystemsPhilips recalls Brilliance CT systems due to scan trigger failure risking inadequate diagnosis and extra radiation.
3 products
FDA•MODERATEAMS Spinal KitWindstone Medical recalls AMS Spinal Kit (Part AMS13683A) due to supplier quality issues with included Lidocaine HCl injection.
8 products
FDA•MODERATEMedtronic EOPA Arterial CannulaMedtronic recalls EOPA 22 Fr arterial cannulae over pinhole leak risk during bypass.
6 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•Proin ER TabletsPegasus recalls Proin ER 145mg tablets for dogs due to failed dissolution specs.
FDA•Ascend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran Etexilate Capsules (150 mg, 75 mg) over impurity/degradation failures.
3 products
FDA•MODERATEMan Fon: 2 productsMan Fon recalls Won Ton Wrappers over undeclared Yellow #5 and Yellow #6 allergens.
2 products
FDA•Mycophenolate Mofetil for InjectionMylan recalls Mycophenolate Mofetil for Injection 500 mg vials due to precipitate.
FDA•MODERATEL-Cath PICC S/L Peripherally Inserted Central CatheterArgon Medical recalls L-Cath PICC catheters (REF 384539, 384464, 384516, 384463) due to hub cracking risk.
2 products
FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls 80+ AMS convenience kits over endotoxin risk in supplied sponges.
4 products
FDA•MODERATEFresenius Kabi: Multiple Rx Only ProductsFresenius Kabi recalls multiple injectable drugs due to hair found in product.
5 products
FDA•MODERATERohto-Mentholatum (Vietnam) Co: multiple drugsRohto-Mentholatum recalls multiple Rohto Cooling Eye Drops over sterility concerns.
8 products
FDA•Glycopyrrolate Oral SolutionPrecision Dose recalls Glycopyrrolate Oral Solution over an unidentified impurity.
FDA•MODERATEMedline Convenience Kits with BD PurPrep 26 mLMedline recalls convenience kits with BD PurPrep 26 mL over Bacillus contamination.
4 products
FDA•Cetirizine Hydrochloride Tablets 5 mgRising Pharma recalls Cetirizine HCl 5 mg tablets over Ranitidine cross-contamination.
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters over surface 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•MODERATESnapshotGLO Wound Imaging DeviceKent Imaging recalls SnapshotGLO wound imaging devices due to battery charging failure.
FDA•MODERATEPipeline Flex Embolization Device with Shield TechnologyMicro Therapeutics recalls Pipeline Flex Embolization Device due to incorrect labeling of implant sizes.
2 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.