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.
GlaxoSmithKline is recalling 593,088 Ventolin inhalers because some units have out-of-specification leak rates, potentially affecting drug delivery.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler Release Kits because misinterpreted instructions may cause tool damage.
VivaCeuticals is recalling RegenErect herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.
VivaCeuticals is recalling RegeneBoost 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 specific lots of Adalat CC (nifedipine) Extended-Release Tablets due to cross-contamination with sorafenib powder.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
BioMerieux SA is recalling NucliSENS Lysis Buffer because colored eluates were observed during whole blood extractions.
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests.
Philips Visicu is recalling eCare Coordinator software due to a defect that may cause missing or redundant data to be saved without user notification.
Alvogen Inc. is recalling Nifedipine Extended-Release Tablets, 90 mg, due to cross-contamination with sorafenib powder found in the inlet air duct.
Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems because electronic markers may be placed at the wrong anatomical position when images are moved between views.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.
Centurion Medical Products is recalling Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.
Intuitive Surgical is recalling da Vinci Xi 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.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpreted instructions may cause tool damage.
Arrow International is recalling 1,351 CG+ Arrow PIC Catheters due to a labeling error where lidstock and banner card codes do not match.
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets due to cross-contamination with sorafenib powder found in the manufacturing facility.
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets 30 mg due to cross-contamination with sorafenib powder.
VivaCeuticals is recalling all lots of RegeneArouse herbal and dietary supplements because they were not manufactured in compliance with current Good Manufacturing Practice regulations.
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests in process.