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.
Becton Dickinson is recalling 5,085,120 BD PosiFlush Prefilled Saline Syringes due to an incorrect stopper that increases injection force and may trigger pump alarms.
Vita 360, LLC is recalling SUPREX Plant Based Nutrition Carb & Sugar Block supplements (Lot #2633) because FDA testing found chromium content at only 16% of the declared amount.
Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.
Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.
Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.
A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
Shirakawa Olympus Co., Ltd. is updating cleaning instructions for the Model CYF-5R Cystonephrofiberscope. Reusable cleaning brushes have been removed from manual cleaning procedures; single-use brushes remain approved.
Baxter is recalling marketing materials for Vascu-Guard Peripheral Vascular Patch because a brochure contains inaccurate information that conflicts with the product's official instructions and prescribing information.
Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.
Olympus updated cleaning instructions for the Model CYF-VHR Cysto-Nephro Videoscope. Reusable brushes have been removed from manual cleaning procedures; single-use brushes remain compatible.
Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.
Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.
Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.
Shiloh Farms recalled 534 cases of Bread for Life Organic 7 Grain due to labeling error: cholesterol and sodium daily values listed in grams instead of milligrams. Product content is accurate.
Olympus has updated cleaning instructions for the EVIS EXERA III Bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; only single-use brushes should be used.
Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.