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.
Silk Vanilla AlmondMilk, 64 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
A DxI 800 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.
Cesarina Sesame Seed Cookies, 16 oz, are being recalled because sesame is not listed in the Contains statement. 40 cases are affected.
Lap Chole Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 85 units are affected.
DxI 600 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 177 systems are affected.
Yoplait Original Strawberry Banana Yogurt, 6 oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 2 units are affected.
Pillsbury Cinnamon Rolls with Original Icing, 8 count, are being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
Velveeta Slices Sharp Cheddar, 16 count, are being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
Xolair (omalizumab injection) 75 mg/0.5 mL is being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 4 units affected.
Clover Valley Lactose Free 2% Reduced Fat Milk, 64 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
Chobani Vanilla Greek Yogurt, 4 oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 3 units are affected.
Laparoscopic Prostatectomy medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 30 units are affected.
ROBOTIC PROSTATECTOMY PACK medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 24 units affected.
UniCel DxI 800 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results. 2,203 systems affected.
T4 Total ELISA kits are being recalled because the expiration date on the kit box label and Certificate of Analysis exceeded the shelf life of the standards and control solutions by two months. 47 units affected.
DAVINCI TRUCUSTOM BUNDLE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 626 units are affected.
Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.
Minute Maid Fruit Punch, 59 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 4 units are affected.
Gen Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 321 units are affected.
Simply Orange Pulp Free Orange Juice in 46 fl oz and 11.5 fl oz bottles is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 2 units affected.
BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are affected.
Milo's Extra Sweet Tea, 1 gallon, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 3 units are affected.
Checkers Famous Seasoned Fries, 28 oz, are being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
GS Endoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 816 units are affected.
GYN Robotic Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized in the kits, causing discoloration. 45 units affected.