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.
Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Vantive US Healthcare is recalling 2,724 Oxiris Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0730, because devices which did not undergo thermoforming could deform and lose performance.
Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.
Fazt & Loud is recalling Lost and Found Energy, Sour Gummy Bear, because a label misprint states 150mg of caffeine when the product contains 300mg.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0725, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Vantive US Healthcare is recalling 115,112 units of the PRISMAFLEX HF1000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Prima Foods International is recalling BarbaCuban 90 Miles to Mojo Marinade because quinine in the product is not declared on the label.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC431Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0720, because devices which did not undergo thermoforming could deform and lose performance.
Wilson-Cook Medical is recalling 60 Nasal Jejunal Feeding Tubes, REF NJFT-10, because they were packaged without the nasal transfer tube component.
Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Organic Spices is recalling 391 cases of Spicely Organic celery salt because the product contains salt and is mislabeled.
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
Olympus is recalling the CleverCut Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320, because devices which did not undergo thermoforming could deform and lose performance.
Organic Spices is recalling 524 cases of Spicely Organic garlic salt because the product contains salt and is mislabeled.
ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.