Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Synergy Rx is recalling Bicarbonate 10% because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling TRI-BLEACHING CREAM because it lacks assurance of sterility and has CGMP deviations. The product is distributed nationwide.
CareFusion is recalling 12,850 MaxGuard Extension Sets because the 0.2 micron filter may leak. These medical devices are used to administer fluids to patients.
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.
Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.
Krispy Kreme Doughnut Corporation is recalling 717 units of Chocolate Iced Sprinkle Theme donuts because they may contain metal pieces.
C2 Therapeutics is recalling 755 C2 CryoBalloon Controller Caps because they may crack when tightened, potentially compromising the device's integrity.
Krispy Kreme Doughnuts Choc Iced Glazed are being recalled due to potential metal pieces. The recall affects specific boxes and single-serve units produced on February 6, 2017.
LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.
Sweets & Desserts, Inc. is recalling Cheesecake Fresa (Strawberry) in Puerto Rico due to undeclared milk and Red #40 food color.
LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.
Whiskey Hill Smokehouse is recalling beef, venison, and ostrich jerky because the products contain soy, a known allergen, that is not declared on the label.
Synergy Rx is recalling Modified Jessner Peel due to lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling salicylic acid and 5-FU prescription products due to lack of assurance of sterility and CGMP deviations.
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
Kiscomedica S.A. is recalling 13 units of the L-Varlock Cage/Trial Implant Holder because the tip holder broke during use.
Goulibeur is recalling 250 units of pure butter shortbreads sold in Maryland because the packaging lists butter but fails to identify milk as an allergen source.
Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.
Nachman's Native Seafood is recalling Smoked Fish spread in various sizes due to undeclared wheat in the soy sauce ingredient.
LBB Imports is recalling Thornton's Hollow Milk Chocolate Jolly Santa because it may contain a piece of plastic that poses a risk to consumers.
Goulibeur is recalling 150 units of butter shortbread with flaked almonds because the packaging fails to identify milk as an allergen source for the butter ingredient.
Synergy Rx is recalling Tretinoin Cream and Gel in all strengths due to a lack of assurance of sterility and CGMP deviations.
Del Monte Fresh Produce is recalling Choice Farms Stuffed Mushrooms due to possible Listeria monocytogenes contamination. The product was distributed in Texas and Kansas.
Goulibeur is recalling Large French Walnut Shortbread because the packaging lists butter but fails to identify milk as an allergen source.
Goulibeur is recalling 800 units of Life in Paris shortbread because the packaging lists butter but fails to identify milk as an allergen source.