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.
Paddywax is recalling about 2,100 fragrance diffusers because their labels omit petroleum distillates, a substance that poses an aspiration hazard if swallowed.
Fenwal is voluntarily recalling 114 AMICUS Exchange Kits because the product was cleared for European use only but distributed in the US.
American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.
Dental EZ Stardental Division is recalling 3,560 StarDental Classique Diamond Dental Burs because a manufacturing issue prevented the diamond coating from adhering properly to the shank.
Bard Peripheral Vascular is recalling Vaccess PTA Balloon Dilatation Catheters because the inflation hub may display an incorrect balloon diameter.
Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.
International Biomedical is recalling VIA Medical Collection Bags because the connector can become occluded if the luer lock is over-tightened.
Purely American, Inc. is recalling Marin County Carrot Cake Mix because the labels are missing the required wheat allergen declaration.
Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.
Embla System LLC is recalling 519 Embletta Gold polysomnography recorders due to a calibration error that may lead to over-titration of sleep therapy.
TG United, Inc. is recalling NoHist Tablets because they are underdosed or have an incorrect dosage regime.
Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.
Biomet is recalling 8 units of Active Articulation E1 hip bearing implants because outer and inner labels display incorrect or conflicting outer diameter sizes.
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Arizona Beverages USA LLC is recalling 10,286 cases of 1-gallon Arizona Southern Style Unsweetened Brewed Tea due to an undeclared Splenda ingredient.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
TG United, Inc. is recalling BroveX PSB DM Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.
Smiling Hill Farm is recalling butter due to elevated standard plate counts and detectable coliform bacteria. The product was distributed in Maine, New Hampshire, and Connecticut.
Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.
Petnet Solution Inc. voluntarily recalled 28 doses of Fludeoxyglucose F 18 Injection in California due to a cGMP deviation.
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.