Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
VivaCeuticals is recalling RegeneFit herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
VivaCeuticals is recalling all lots of RegeneBlast herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 30 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility's inlet air duct.
Philips Medical Systems is recalling 27 BrightView X gamma cameras because a brake hub assembly error can cause the detector to backdrive.
Agilent Technologies is recalling Bond Elut OMS cards because they were marketed without the required FDA 510(k) clearance.
Fresenius Kabi USA is recalling 118,224 vials of Fluphenazine Decanoate Injection because the drug was found to be subpotent.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
VivaCeuticals is recalling RegeneSlim herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.
Beckman Coulter is recalling Rack ID Labels for AU680 and AU5800 analyzers because the displayed ID number and barcode do not match.
Lupin Pharmaceuticals is recalling Quinapril 5 mg tablets because they failed impurity specifications. The recall covers 15,168 bottles distributed nationwide.
Beckman Coulter is recalling specific UniCel DxC 600i SYNCHRON Access Clinical Systems because a circuit board defect can cause the device to stop running and cancel tests.
Alvogen, Inc. is recalling Adalat CC (nifedipine) 60 mg extended-release tablets because residual sorafenib powder was found in the manufacturing facility's inlet air duct.
Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.
Siemens is recalling ADVIA Chemistry Enzyme 2 Calibrators due to a positive bias of up to 41% in AST and AST_c assay results.
Agfa Healthcare is recalling 81 DX-D600 imaging packages because a dent marker may fall from the overhead rail.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Thor Motor Coach is recalling 2017 Palazzo 36.1 and 36.3 motorhomes because the federal certification label lists an incorrect front tire rim size, which could lead to unsafe driving conditions if the rim is replaced based on that error.
Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.
Give and Go Prepared Foods is recalling Two-Bite Turtle Brownie Party Platters because dried weevil larvae may be present in the product.
Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.