Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

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.

29626–29650 of 50499

HighFDA (Food)·F-0908-2018·2018-03-14
Double Cola Cherry SKI Lemon Orange Soda Recalled for Missing Allergen Labeling
Double-Cola Co. is recalling Cherry SKI Lemon Orange Authentic Citrus Soda 12 oz cans because the label failed to list Yellow #5 and Red 40.
Product
Cherry SKI LEMON ORANGE AUTHENTIC CITRUS SODA 12 oz can CONTAINS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, LEMON JUICE CONCENTRATE, ORANGE JUICE CONCENTRATE, CITRIC ACID, NATURAL FLAVOR, SODIUM BENZOATE (PRESERVATIVE), CAFFEINE, CELLULOSE GUM, RED #4, GUM ARABIC, BLUE #1.…
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0907-2018·2018-03-14
Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility
Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.
Product
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2018·2018-03-14
Mindray A7 Anesthesia Delivery System Recalled for Software Defect
Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.
Product
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2018·2018-03-14
Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns
Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to infection.
Product
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Category
Medical Device
Distribution
32 states
HighFDA (Food)·F-0880-2018·2018-03-14
Life Change Fat Burner Recalled for Unlabeled Soy Allergen
Get The Tea is recalling Life Change Fat Burner because the product contains soy, which is not listed on the label.
Product
Life Change Fat Burner, 90 Gel Caps!, Burn Fat!, Remove fat from the liver! 1000mg; 2 capsules daily
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0883-2018·2018-03-14
Vitalab Vitamin C Supplement Recalled for Undeclared Milk Allergen
Vitalab Co Inc is recalling specific lots of Natural Source Vitamin C dietary supplements because they contain lactose but fail to declare the major food allergen milk on the label.
Product
Product packaged in the following ways A) Sonne's, No. 17, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.) Contents - 120 Tablets, National Distributors: Sonne's Organic Foods, Inc. N. Kansas City, MO 64116; B) Springreen, No. 87, Natural Source Vitamin C…
Category
Food
Distribution
29 states
HighFDA (Devices)·Z-0840-2018·2018-03-14
Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors
Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.
Product
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives for ophthalmic surgery because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0839-2018·2018-03-14
Philips Brilliance Big Bore CT Software Recall for Image Generation Errors
Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.
Product
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2018·2018-03-14
Toshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba is recalling 17 INFX-8000F Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Product
INFX-8000F Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0881-2018·2018-03-14
King of Pops Recalls Key Lime Pie Pops for Undeclared Soy Allergen
King of Pops is recalling Key Lime Pie Handcrafted All-Natural Pops because they contain undeclared soy. Consumers should stop eating the product.
Product
Key Lime Pie Handcrafted All-Natural Pop; Net Wt. 3.2 OZ (90g)
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0843-2018·2018-03-14
Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Product
INFX-8000C Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0835-2018·2018-03-14
Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results
Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.
Product
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION…
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0886-2018·2018-03-14
Gasco Industrial Recalls BELCA Soy Sauce for Undeclared Wheat Allergen
Gasco Industrial, Corp. is recalling BELCA Soy Sauce in Puerto Rico because the product contains an undeclared wheat allergen.
Product
BELCA Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Distribuido por: Mister Price Inc. San Juan, P.R. 00936
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0921-2018·2018-03-14
Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results
Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.
Product
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0890-2018·2018-03-14
Barq's Root Beer Cans Recalled for Sharp Edges
Heartland Coca-Cola Bottling Company is recalling Barq's Root Beer cans due to sharp edges that could cause cuts.
Product
Barq's Root Beer 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
Category
Food
Distribution
6 states
HighFDA (Food)·F-0894-2018·2018-03-14
Heartland Coca-Cola Recalls Grape Fanta Cans Due to Sharp Edges
Heartland Coca-Cola Bottling Company is recalling 766,271 cases of Grape Fanta 12 oz cans because sharp edges on the cans could cause cuts to consumers' mouths.
Product
Grape Fanta, Grape Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0906-2018·2018-03-14
Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns
Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.
Product
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0899-2018·2018-03-14
Heartland Coca-Cola Recalls Cans with Sharp Edges
Heartland Coca-Cola Bottling Company is recalling specific cans of Coca-Cola, Original Taste, because sharp edges were observed that could cause cuts to consumers' mouths.
Product
Coca-Cola, Original Taste, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
Category
Food
Distribution
6 states
HighFDA (Food)·F-0891-2018·2018-03-14
Heartland Coca-Cola Recalls Diet Coke Lime Cans Due to Sharp Edges
Heartland Coca-Cola Bottling Company is recalling Diet Coke Lime cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.
Product
Diet Coke Lime, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0851-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2018·2018-03-14
DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk
DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.
Product
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2018·2018-03-14
Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.
Product
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0884-2018·2018-03-14
Emerald Glazed Walnuts Recalled for Undeclared Nuts
Snyder's-Lance is voluntarily recalling 6.5 oz Emerald brand Glazed Walnuts due to undeclared peanuts, almonds, cashews, and pecans.
Product
Emerald brand Glazed Walnuts; Net WT. 6.5 OZ; Re-sealable pouch
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2018·2018-03-14
Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss
Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.
Product
2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide