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.
GE Healthcare is recalling Proteus XR/a radiographic systems because they may fail to provide an audible indication when an exposure is complete.
Getinge is recalling one HEMASHIELD GOLD vascular graft that was incorrectly packed in a carton labeled for a HEMASHIELD PLATINUM graft.
Johnson Matthey Inc. is recalling fentanyl citrate active pharmaceutical ingredient due to potential glass contamination.
Preferred Pharmaceuticals is recalling 79 bottles of Fexofenadine HCl 180 mg tablets because they failed impurities and degradation specifications.
UNFI General Corporate is recalling Apetina Marinated Olives & Feta in Olive Oil because the product was held at room temperature despite requiring refrigeration.
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps with PharmGuard Server Software due to potential wireless network connectivity issues caused by a Radio Module defect.
Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2% due to a finding of metal particulate matter in the filling room. No particulates were identified in the product itself.
Musculoskeletal Transplant Foundation is recalling nine QuickGraft Model 430PST units because the label measurement was not taken under tension, potentially extending surgical time.
Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.
Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.
Siemens Healthcare Diagnostics is recalling 169 kits of the Atellica IM anti-CCP IgG assay because a reagent carryover mitigation step fails to complete on the analyzer.
Abbott is recalling 159 APS Accelerator modular systems because the safety pacemaker label is missing. The Operations Manual has been updated to specify a 200 mm minimum safety distance for pacemaker wearers.
Philips is recalling infant/child defibrillator pads due to incorrect age range labeling on the foil packaging.
Danone is recalling Silk Soymilk Vanilla Bag-In-Box because the outer box incorrectly identifies the product as almond milk. The internal product is correctly labeled as soymilk.
Vital Scientific N.V. is recalling two V-Twin automated chemistry analyzers in New York because a software lockup prevents the instruments from producing patient results.
GN Otometrics is recalling Gold Cup and Snap Leadwires because the electrode lead connector has a protruding conductor beyond the insulation.
Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.
Johnson Matthey Inc. is recalling Oxaliplatin Active Pharmaceutical Ingredient due to potential glass contamination. The product was distributed nationwide in the United States.
ConAgra Foods is recalling Udi's Classic Hamburger Buns due to the potential presence of foreign material. The product was distributed to wholesale and retail locations in 13 states.
Honda is recalling 2019 CR-V vehicles because the owner's guide incorrectly describes the Passenger Airbag Off indicator, potentially increasing injury risk in a crash.
Aurolife Pharma is recalling specific lots of Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets because they failed impurities and degradation specifications.
Philips is recalling IntelliVue 1.4 GHz Remote Antenna cables used with MX40 monitors because they lack the required rating for some installations.
Martin's Famous Pastry Shoppe is recalling 8 Sandwich Potato Rolls due to a potential introduction of cation exchange resin, a brown water softener, during production.
Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules because routine stability testing detected high levels of impurities.
La Orocovena Biscuit de PR, Inc. is recalling Coconut Macaroons because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.