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.
International Foodsource, LLC is recalling Valued Naturals Natural Coconut because laboratory analysis found 28.1 ppm sulfites.
Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.
Nissan is recalling 2014 Infiniti QX80 vehicles because the certification label lists an incorrect Gross Axle Weight Rating, potentially allowing vehicle overload.
Nicomex Inc. is recalling Color Para Tamal and Camaron Entero due to unapproved color and undeclared sulfites found by NYSDAM.
Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.
Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Leica Biosystems is recalling 78 units of the ScanScope System software to clarify usage with specific RUO products.
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.
Actavis Elizabeth LLC is recalling 5,148 bottles of Alprazolam Extended-Release Tablets, 3 mg, because the product failed to meet dissolution specifications.
Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.
AlterG, Incorporated is recalling 2,221 accessory shorts for the AlterG Anti-Gravity Treadmill because unapproved material caused them to stretch unusually, making them uncomfortable for patients.
GE Healthcare is recalling GSI Viewer software because changing the region of interest or zooming may result in inaccurate line measurements.
Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee System because the product may be mislabeled, which could result in the incorrect implant being used.
Medicamat is recalling 71 units of the Punch Hair Matic surgical hair transplant device due to misbranded marketing literature.
Horiba Medical is recalling ABX PENTRA calibrators and controls because target values for the Creatinine Rate Blank Method were updated.
Medtronic is recalling O-arm Imaging Systems because a review found gaps in compliance with FDA labeling requirements for user information.
Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.
AMO Puerto Rico Manufacturing is recalling 169 units of TECNIS CL Foldable Silicone IOLs because they may be labeled with the incorrect diopter power.
KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.
Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.
DJO Surgical is recalling 10 units of FMP X-alt Acetabular Liners that were mistakenly packaged and labeled as different models and sizes.
Teva Pharmaceuticals USA is recalling 2,494 bottles of Hydroxyzine Pamoate Capsules, 100 mg, because the active ingredient was incorrectly released for use.