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 Medical Systems Nederland is recalling 2 Allura Xper FD20 systems because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 23 units of the Allura Xper FD20 Biplane, model 722013, because the drip tray beneath the cooling unit may not have been installed.
Lippert is recalling certain bus windows that may have illegible DOT markings, failing to comply with Federal Motor Vehicle Safety Standard 205.
AvKARE is recalling 7,991 cartons of Rosuvastatin Tablets, USP 10 mg, because the product was out of specification for dissolution.
SpecGx is recalling 74,544 bottles of Oxycodone and Acetaminophen CII Tablets, 7.5 mg/325 mg, because of the potential for the imprint to be missing on tablets.
Beckman Coulter is recalling 6,457 UniCel DxI 800 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.
Rovira Biscuit is recalling 6,671 units of 100to en boca snack crackers over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Integra LifeSciences is recalling 1,301 Codman Microsensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
Rovira Biscuit is recalling 16,478 units of Great Value Vainilla Crackers over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Philips Healthcare (Suzhou) is recalling 35 Incisive CT systems over the potential for an incomplete scan due to an unstable connection inside the floating sensor.
Alembic Pharmaceuticals is recalling Fesoterodine Fumarate Extended-release Tablets, 8 mg, because levels of a diester impurity exceeded the specification limit.
Signature Formulations is recalling 1,458 containers of ORL Kids Natural Toothpaste, bubblegum flavour, over current good manufacturing practice deviations.
Rovira Biscuit is recalling 22,114 units of Vanilla Econo, Galletas de Vainilla, over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Signature Formulations is recalling 570 bottles of ORL Kids Mouthwash, bubblegum flavour, over current good manufacturing practice deviations.
SpecGx is recalling 287,988 bottles of Oxycodone and Acetaminophen CII Tablets, 10 mg/325 mg, because of the potential for the imprint to be missing on tablets.
Ziyad Brothers Importing is recalling 575 cases of Baraka Gourmet Pastry Kunafe because the product may contain partially hydrogenated oils.
Siemens Medical Solutions is recalling LUMINOS Lotus Max and Luminos dRF Max systems because switching quickly between organ programs may result in incorrect collimation.
Integra LifeSciences is recalling 5,116 Codman CereLink ICP Sensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
Ziyad Brothers Importing is recalling 2,865 cases of Baraka French Style Puff Pastry because the product may contain partially hydrogenated oils.
Rovira Biscuit is recalling 71,492 units of Vanilla Treats Crackers and Mini Vanilla Treats over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Beckman Coulter is recalling 1,272 UniCel DxI 600 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.
Rovira Biscuit is recalling 29,246 units of Tita Crackers over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Applied Medical Resources is recalling 450 units of the Kii Low Profile Bladed Dual Pack because of the potential for extended length of the blade obturator after assembly.
Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.
Sophysa is recalling 105 Pressio 2 ICP Monitoring Systems following customer complaints of the Pressio monitor rebooting.