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 14 units of the Allura Xper FD10/10, model 722005, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 633 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Medline is recalling 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 12 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Philips Medical Systems Nederland is recalling 93 units of the Allura Xper FD10, model 722003, 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.
Alembic Pharmaceuticals is recalling Fesoterodine Fumarate Extended-release Tablets, 8 mg, because levels of a diester impurity exceeded the specification limit.
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.
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.
Rovira Biscuit is recalling 9,838 units of Tempting Crackers over undeclared colours FD&C Yellow #6 and FD&C Red 40.
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 1,301 Codman Microsensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.
Signature Formulations is recalling 570 bottles of ORL Kids Mouthwash, bubblegum flavour, over current good manufacturing practice deviations.
Sophysa is recalling 105 Pressio 2 ICP Monitoring Systems following customer complaints of the Pressio monitor rebooting.
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.
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.
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 71,492 units of Vanilla Treats Crackers and Mini Vanilla Treats over undeclared colours FD&C Yellow #6 and FD&C Red 40.
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.