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.
Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.
Fresenius Medical Care is recalling 32,592 bags of Sodium Chloride 0.9% Injection because chemical indicators were not positioned properly during sterilization.
Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the product converting to Solifenacin Tartrate.
Siemens is recalling Artis Q.zen angiography systems because a software issue could block stand and table movements.
Noven Therapeutics is recalling Daytrana (methylphenidate) patches because the delivery system failed mechanical peel and shear specifications.
Noven Therapeutics is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed mechanical peel and shear specifications.
XTANT Medical is recalling 26 units of OsteoSelect DBM Putty because three devices contained 5.0cc instead of the labeled 10.0cc.
Jubilant Cadista Pharmaceuticals is recalling 89,376 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on tablet edges.
Philips is recalling 128 Allura CV20 X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.
Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.
Philips is recalling the Velara X-ray generator because a capacitor may fail after electrical surges, preventing image acquisition.
Philips is recalling 20 Integris Allura 9 systems because a capacitor may fail, preventing image acquisition.
Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.
Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.
The Binding Site Group is recalling 30 Rheumatoid Factor kits distributed in California because calibration errors may cause falsely abnormal test results.
Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.
Philips is recalling 534 MultiDiagnost Eleva X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.
Deroyal Industries is recalling 669 units of Teleflex Pilling Aortic Punches because the sterile packaging may be compromised, potentially affecting cardiovascular surgical procedures.
Braemar Manufacturing is recalling DL950 Holter Monitors because a software issue prevents new patient studies from starting.
Sunstar Guangzhou Ltd. is voluntarily recalling 260,000 tubes of GUM Toothpaste in Florida due to a cGMP deviation. The recall was initiated in February 2020.
Garza Food Ventures is recalling Siete Grain Free Burrito Size Tortillas because the sodium content is 340 mg per serving, not the 15 mg declared on the label.
Redline Pharmacy Solutions is recalling Acetylcysteine Ophthalmic 10% Solution due to a lack of processing controls. The product was sold to patients in Nebraska.
Les Chateaux De France is recalling Butterfly Shrimp 16/20 due to undeclared sodium metabisulfite in the coconut ingredient.
Belle Chemical is recalling 100% Sodium Hydroxide Drain Cleaner because the label violates the Federal Hazardous Substance Act by omitting the word 'poison' and mandatory hazard statements.
The Binding Site Group is recalling 462 VaccZyme assay kits due to performance deterioration that may cause falsely elevated antibody results.