September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical: 56
Severe: 123
High: 285
Moderate: 154
Low: 13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 19% are Severe.

Which agencies issued them

301–400 of 631

SevereFDA (Food)·F-1336-2020·2020-09-09
Triple B Corporation Recalls Peeled Onions Due to Salmonella Newport Risk
Triple B Corporation is recalling Charlie's Produce peeled onions in Alaska due to potential Salmonella Newport contamination.
Product
Charlie s Produce Anchorage, RED Peeled Onions, Jumbo, Ready To Eat (RTE), keep refrigerated. Shelf-life: packing date plus 6 days, packed in corrugated cardboard box. Net. wt. 20 lbs., no UPC. Product was peeled and packaged by Charlie s Produce 9401 King St., Anchorage, AK 995
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1338-2020·2020-09-09
Taylor Farms Recalls Yellow Onions for Potential Salmonella Contamination
Taylor Farms Texas, Inc. is recalling specific yellow onion products due to a potential for contamination by Salmonella.
Product
Taylor Farms Foodservice Onion Yellow Dice 1/8" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Dice 1/4" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Slice 1/4" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Dice 1/4" Pack Size 2/5#; Taylor Farms Foodservi
Category
Food
Distribution
4 states
SevereFDA (Food)·F-1498-2020·2020-09-09
Sundial Herbal Arthritis Formula Recalled for Misbranding and Unapproved Drug Status
Sundial Herbal Products is recalling its Traditional Herbal Formula for Arthritis because the product is misbranded and considered an unapproved drug.
Product
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" packaged in boxes
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1389-2020·2020-09-09
Giant Eagle Recalls MD Dip-Rueben Due to Salmonella Newport Risk
Giant Eagle is recalling MD Dip-Rueben products due to potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Product
MD Dip-Rueben PLU# 24659500000. Expiration date 8/6/2020. Ingredients: REUBEN DIP [COOKED CORNED BEEF ROUND (CURED WITH UP TO 15% OF A SOLUTION OF: WATER, SALT, SUGAR, SODIUM PHOSPHATE, POTASSIUM LACTATE, SODIUM ERYTHORBATE, SODIUM NITRITE, SODIUM DIACETATE, GARLIC POWDER, EXTRAC
Category
Food
Distribution
5 states
SevereFDA (Drugs)·D-1571-2020·2020-09-09
SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
SG24 LLC is recalling SkinGuard 24 All-Day Hand Sanitizer because it is an unapproved new drug containing methanol.
Product
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1507-2020·2020-09-09
Sundial Herbal Products Recalls Ethiopian Coffee for Unapproved Drug Claims
Sundial Herbal Products is recalling Ethiopian Coffee under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Product
Ethiopian Coffee
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1380-2020·2020-09-09
Giant Eagle Recalls Buffalo Chicken Salad Due to Salmonella Risk
Giant Eagle is recalling MD Buffalo Chicken Salad due to potential Salmonella Newport contamination in onions. Consumers in IN, OH, MD, WV, and PA should not eat the product.
Product
MD Buffalo Chicken Salad PLU#22664600000. Expiration date: 8/4/2020 Expiration date 8/4/2020.Ingredients: SALAD [ROMAINE LETTUCE, BUTTERMILK RANCH (SEE DRESSING CUP), GRAPE TOMATOES, BACON BITS (BACON CURED WITH: WATER, SALT, SODIUM PHOSPHATES, SODIUM ERYTHORBATE, SODIUM NITRITE
Category
Food
Distribution
5 states
SevereFDA (Food)·F-1361-2020·2020-09-09
Whole Foods Market Recalls Sliced Cheese for Undeclared Egg Allergen
Whole Foods Market is recalling sliced Mitica Mahon cheese nationwide due to undeclared lysozyme from egg whites, posing a risk to individuals with egg allergies.
Product
Whole Foods Market Mitica Mahon PLU 29341800000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1373-2020·2020-09-09
Giant Eagle Chickpea and Carrot Salad Recalled for Salmonella Risk
Giant Eagle is recalling Chickpea & Carrot Salad Greek Dressing due to potential Salmonella Newport contamination in onions.
Product
Chickpea & Carrot Salad Greek Dressing PLU#21665100000. Expiration date 8/5/2020. Ingredients:SALAD [CHICKPEAS (CHICKPEAS, WATER, SALT, DISODIUM EDTA (TO PRESERVE COLOR)), VINAIGRETTE (WATER, VEGETABLE OIL [SOYBEAN AND/OR CANOLA], APPLE CIDER VINEGAR, RED WINE VINEGAR, EXTRA VIRG
Category
Food
Distribution
5 states
SevereFDA (Food)·F-1472-2020·2020-09-09
Sundial Blue Vervain Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Blue Vervain herbal products under a permanent injunction because the products are misbranded and deemed unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags
Category
Drug
Distribution
1 state
HighFDA (Food)·F-1342-2020·2020-09-09
Taylor Farms Foodservice Onion Creole Mix Recalled for Salmonella Risk
Taylor Farms Texas, Inc. is recalling specific lots of Foodservice Onion, Creole Mix due to a potential for contamination by Salmonella.
Product
Taylor Farms Foodservice Onion, Creole Mix Pack Size 2/5#
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-2934-2020·2020-09-09
Siemens Symbia S and T Series SPECT Systems Recalled for Detector Motion
Siemens Medical Solutions is recalling 412 Symbia S and T Series SPECT systems due to a defect that may cause unintended slow motion of the detectors.
Product
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies u
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1404-2020·2020-09-09
Giant Eagle Recalls Stuffed Chicken Breast Due to Salmonella Newport Risk
Giant Eagle is recalling Stuffed Bone In Chicken Breast Gourmet due to potential Salmonella Newport contamination in onions.
Product
STUFFED BONE IN CHICKEN BREAST GOURMET (INDEPENDENT PLU). PLU# 25089000000. Expiration date 8/5/2020. Ingredients: STUFFED BONE IN CHICKEN BREAST [CHICKEN, STUFFING [SPREAD (PURIFIED WATER, SOYBEAN OIL, PALM KERNEL & PALM OIL, SALT, SOY LECITHIN, VINEGAR, NATURAL FLAVORS, VITAMIN
Category
Food
Distribution
5 states
HighFDA (Food)·F-1406-2020·2020-09-09
Giant Eagle Recalls Stuffed Turkey Breast Due to Salmonella Risk
Giant Eagle is recalling Stuffed Turkey Breast Gourmet products in five states due to potential Salmonella Newport contamination in onions.
Product
STUFFED TURKEY BREAST GOURMET (INDEPENDENT PLU). PLU# 25093400000. Expiration date 8/5/2020. Ingredients: STUFFED TURKEY BREAST [TURKEY [TURKEY BREAST ROAST W 25% SOLUTION OF TURKEY BROTH, TURKEY SEASONING (MALTODEXTRIN, SALT, SUGAR, YEAST EXTRACT, DEXTROSE, TURKEY BROTH, ONION P
Category
Food
Distribution
5 states
HighFDA (Food)·F-1383-2020·2020-09-09
Giant Eagle Recalls Grilled Vegetables Due to Salmonella Newport Risk
Giant Eagle is recalling Grilled Vegetables with an expiration date of 8/6/2020 due to potential contamination with Salmonella Newport in onions.
Product
Grilled Vegetables PLU# 23657100000. Expiration date: 8/6/2020 Ingredients: GRILLED VEGETABLES [RED ONION, GREEN BELL PEPPER, YELLOW SQUASH, ZUCCHINI, ASPARAGUS, EGGPLANT, RED BELL PEPPER, YELLOW BELL PEPPER, OIL BLEND (CANOLA OIL, EXTRA VIRGIN OLIVE OIL), SALT, BLACK PEPPER]. On
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2920-2020·2020-09-09
Remel Bordetella pertussis Agglutinating Serum Recalled for False Negative Results
Remel Europe Ltd. is recalling Thermo Scientific Remel Bordetella pertussis Agglutinating Serum because it may produce false negative results for serotypes 1 and 3.
Product
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1371-2020·2020-09-09
Giant Eagle Recalls Tuscan Chicken Salad for Salmonella Newport Risk
Giant Eagle is recalling Tuscan Chicken Salad due to potential contamination with Salmonella Newport in onions. Consumers should discard the product.
Product
Tuscan Chicken Salad PLU# 20730400000. Expiration date 8/3/2020. Ingredients:TUSCAN CHICKEN SALAD (CHICKEN [OVEN ROASTED OR ROTISSERIE CHICKEN, SEASONING (PAPRIKA [PAPRIKA, <2% SILICON DIOXIDE (ANTICAKING)], GARLIC POWDER, BLACK PEPPER, SALT)], ITALIAN DRESSING [WATER, SOYBEAN OI
Category
Food
Distribution
5 states
HighFDA (Food)·F-1399-2020·2020-09-09
Giant Eagle Recalls 12-Inch Deluxe Pizzas Due to Salmonella Risk
Giant Eagle is recalling 12-inch Deluxe Pizzas with an expiration date of 8/7/2020 due to potential Salmonella Newport contamination in onions.
Product
12" DELUXE PIZZA (INDEPENDENT PLU) .PLU# 25071800000. Expiration date 8/7/2020. Ingredients: 12" DELUXE PIZZA [PIZZA DOUGH [FLOUR (ENRICHED WHEAT FLOUR [WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, SHORTENING (SOYBE
Category
Food
Distribution
5 states
HighFDA (Food)·F-1396-2020·2020-09-09
Giant Eagle Pierogie Lasagna Roll Up Recalled for Salmonella Newport Risk
Giant Eagle is recalling Pierogie Lasagna Roll Up products due to potential contamination with Salmonella Newport in onions.
Product
PIEROGIE LASAGNA ROLL UP (INDEPENDENT PLU) PLU# 25065000000. Expiration date 8/4/2020. Ingredients: PIEROGIE LASAGNA ROLL UP [MASHED POTATOES (POTATOES, SKIM MILK, BUTTER [CREAM, SALT], WHOLE MILK, SALT, DISODIUM PYROPHOSPHATE [ADDED TO MAINTAIN COLOR], POTASSIUM SORBATE [PRESER
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2927-2020·2020-09-09
Siemens Dimension Vista Troponin I Reagent Cartridge Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling Dimension Vista High Sensitivity Troponin I reagent cartridges because they may exhibit a negative bias with patient samples.
Product
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1368-2020·2020-09-09
Giant Eagle Recalls Greek Salad for Potential Salmonella Newport Contamination
Giant Eagle is recalling Greek Salad products due to potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Product
Greek Salad Small PLU#20500200000. Expiration date 8/4/2020. Ingredients:GREEK SALAD [CHICK PEAS (CHICK PEAS, WATER, SALT, DISODIUM EDTA (TO PRESERVE COLOR)), CUCUMBER, ROMAINE LETTUCE, SPRING MIX (GREEN LEAVES [FRISEE, WILD ARUGULA, MACHE], RED LEAVES [RADICCHIO], MAY CONTAIN T
Category
Food
Distribution
5 states
HighFDA (Food)·F-1358-2020·2020-09-09
Whole Foods Market Recalls Chimay Biere Cheese for Undeclared Egg
Whole Foods Market is recalling Chimay Biere cheese due to undeclared egg whites. The product was sold nationwide with sell-by dates until September 11, 2020.
Product
Whole Foods Market Chimay Biere PLU 29351700000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2922-2020·2020-09-09
Teleflex Pleur-evac Thoracic Catheters Recalled for Potential Sterility Issue
Teleflex Medical Inc is recalling Pleur-evac Thoracic Catheters due to a potential sterility issue. The recall affects 700 units distributed across 25 US states.
Product
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
Category
Medical Device
Distribution
27 states
HighFDA (Food)·F-1345-2020·2020-09-09
Taylor Farms Quiche Florentine Recalled for Potential Salmonella Contamination
Taylor Farms Texas, Inc. is recalling 76 units of Retail Quiche Florentine 1/10 oz. due to potential Salmonella contamination. The product was distributed in Texas, Oklahoma, Kansas, and Missouri.
Product
Taylor Farms Retail Quiche Florentine 1/10 oz.
Category
Food
Distribution
4 states
HighFDA (Food)·F-1417-2020·2020-09-09
Giant Eagle Smoke-Stacked Sandwich Recalled for Potential Salmonella Newport Contamination
Giant Eagle is recalling Smoke-Stacked Sandwiches due to potential Salmonella Newport contamination in onions. Consumers should discard the product.
Product
MD S&F: SMOKE-STACKED SANDWICH PLU#29662600000. Expiration date 8/1/2020. Ingredients: SANDWICH [BUN (ROLL [ENRICHED FLOUR (WHEAT, MALTED BARLEY, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, FLOUR (WHEAT, MALTED BARLEY), SUGAR, YEAST, PALM OIL, WHEA
Category
Food
Distribution
5 states
HighFDA (Food)·F-1409-2020·2020-09-09
Giant Eagle Recalls 6-Inch Cold Italian Hero Sandwiches for Salmonella Risk
Giant Eagle is recalling 6-inch Cold Italian Hero sandwiches due to potential Salmonella Newport contamination in onions. The product was sold in Indiana, Ohio, Maryland, West Virginia, and Pennsylvania.
Product
ITALIAN HERO, 6", COLD (INDEPENDENT PLU) PLU#25118600000. Expiration date 8/2/2020. Ingredients: 6" COLD ITALIAN HERO [BUN [ENRICHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, 2% OR LESS OF YEAST, SA
Category
Food
Distribution
5 states
HighFDA (Food)·F-1375-2020·2020-09-09
Giant Eagle Recalls Green Bean Portabella Due to Salmonella Risk
Giant Eagle is recalling Green Bean Portabella prepared foods due to potential Salmonella Newport contamination in onions.
Product
Green Bean Portabella PLU#22657400000. Expiration date 8/6/2020. Ingredients:GREEN BEANS PORTABELLA [GREEN BEANS, PORTABELLA MUSHROOMS, RED ONION, RED BELL PEPPER, OIL BLEND (CANOLA OIL, EXTRA VIRGIN OLIVE OIL), SALT, DEHYDRATED GARLIC, PEPPER]. Onions are cooked.
Category
Food
Distribution
5 states
HighFDA (Food)·F-1341-2020·2020-09-09
Taylor Farms Recalls Cabbage Coleslaw Due to Salmonella Risk
Taylor Farms Texas, Inc. is recalling specific lots of foodservice cabbage coleslaw because of a potential Salmonella contamination.
Product
Taylor Farms Foodservice Cabbage, Coleslaw Pack Size 6/10#; Taylor Farms Foodservice Cabbage, Coleslaw Pack Size 3/10#
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-2925-2020·2020-09-09
Brainlab Cirq Arm System Recalled for Reduced Holding Force
Brainlab AG is recalling 21 Cirq Arm Systems because prolonged non-use can reduce the holding force of the positioning arm.
Product
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1405-2020·2020-09-09
Giant Eagle Recalls Stuffed Boneless Chicken Breast Due to Salmonella Risk
Giant Eagle is recalling Stuffed Boneless Chicken Breast Gourmet due to potential Salmonella Newport contamination in onions.
Product
STUFFED BONELESS CHICKEN BREAST GOURMET (INDEPENDENT PLU). PLU# 25089400000. Expiration date 8/5/2020. Ingredients: STUFFED BONELESS CHICKEN BREAST [CHICKEN, STUFFING [SPREAD (PURIFIED WATER, SOYBEAN OIL, PALM KERNEL & PALM OIL, SALT, SOY LECITHIN, VINEGAR, NATURAL FLAVORS, VITAM
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2916-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes or tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1402-2020·2020-09-09
Giant Eagle Recalls 12-Inch Vegetable Pizza for Potential Salmonella Contamination
Giant Eagle is recalling 12-inch vegetable pizzas due to potential Salmonella Newport contamination in onions. Consumers should not eat the product.
Product
12" VEGETABLE PIZZA (INDEPENDENT PLU) PLU# 25086700000. Expiration date 8/5/2020. Ingredients: 12" VEGETABLE PIZZA [SPREAD (CREAM CHEESE [PASTEURIZED CULTURED MILK & CREAM, SALT, STABILIZERS (XANTHAN, CAROB BEAN, AND/OR GUAR GUMS)], MAYONNAISE [SOYBEAN OIL, WATER, EGGS, EGG YOLKS
Category
Food
Distribution
5 states
HighFDA (Food)·F-1416-2020·2020-09-09
Giant Eagle Recalls Sausage Peppers and Onions Over Penne for Salmonella Risk
Giant Eagle is recalling Sausage Peppers and Onions Over Penne due to potential Salmonella Newport contamination in onions.
Product
SAUSAGE PEPPERS AND ONIONS OVER PENNE PLU#28660700000. Expiration date 8/5/2020. Ingredients: MEAL [PASTA MARINARA [MARINARA [TOMATOES (TOMATOES, TOMATO PUREE), ONION, <2%: SUGAR, GARLIC, OIL BLEND (CANOLA OIL, OLIVE OIL), BASIL, OREGANO, SALT, BLACK PEPPER, RED PEPPER FLAKES, CO
Category
Food
Distribution
5 states
HighFDA (Food)·F-1360-2020·2020-09-09
Whole Foods Market Recalls Sliced Cheese for Undeclared Egg Allergen
Whole Foods Market is recalling specific sliced cheese products because they contain undeclared lysozyme from egg whites, posing a risk to individuals with egg allergies.
Product
Whole Foods Market Chimay Grand Cru PLU 29388800000 and Whole Foods Market Lactalis MIMOLETTE Aged 12 MONTHS PLU 25704400000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighCPSC·20178·2020-09-09
Royal Gourmet Recalls Patio 2-Burner Gas Grills Due to Fire Hazard
Royal Gourmet is recalling about 1,100 Patio 2-Burner Propane Gas Grills sold at Wayfair.com because the plastic regulator hose can melt and catch fire.
Product
Patio 2-Burner Propane Gas Grills with Side Shelves
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-1376-2020·2020-09-09
Giant Eagle Recalls Italian Half Subs for Potential Salmonella Contamination
Giant Eagle is recalling Italian Half Subs sold in five states due to potential Salmonella Newport contamination in onions.
Product
Italian Half Sub PLU#22657700000. Expiration date 8/4/2020. Ingredients:ITALIAN SUB [ROLL (ENRICHED FLOUR [WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID], WATER, YEAST, CONTAINS 2% OR LESS OF THE FOLLOWING: CORN SYRUP, WHEAT GLUTEN, S
Category
Food
Distribution
5 states
HighFDA (Food)·F-1344-2020·2020-09-09
Taylor Farms Southwest Salad Recalled for Potential Salmonella Contamination
Taylor Farms Texas, Inc. is recalling 65 cases of Southwest Salad deli kits due to potential Salmonella contamination. The product was distributed in Texas, Oklahoma, Kansas, and Missouri.
Product
Taylor Farms Deli Kit, Southwest Salad (no protein) 2 count
Category
Food
Distribution
4 states
HighFDA (Food)·F-1362-2020·2020-09-09
Whole Foods Market Recalls Piave Vecchio Cheese for Undeclared Egg
Whole Foods Market is recalling Piave Vecchio cheese nationwide due to undeclared egg whites (lysozyme). Consumers with egg allergies should not consume the product.
Product
Whole Foods Market AGRIFORM PIAVE VECCHIO PLU 29336200000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1407-2020·2020-09-09
Giant Eagle Potato and Cheese Pierogies Recalled for Salmonella Risk
Giant Eagle is recalling Potato and Cheese Pierogies due to potential Salmonella Newport contamination in onions. Consumers should not eat the product.
Product
POTATO AND CHEESE PIEROGIES (INDEPENDENT PLU)PLU#25118000000. Expiration date 8/5/2020. Ingredients: POTATO & CHEESE PIEROGIES [PIEROGI [WATER, ENRICHED FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMINE, RIBOFLAVIN, FOLIC ACID), POTATO FLAKES (POTATOES, MONO & DIGLYCERIDES, SODIUM ACID
Category
Food
Distribution
5 states
HighFDA (Food)·F-1339-2020·2020-09-09
Taylor Farms Recalls Pepper Fajita Mix Due to Salmonella Risk
Taylor Farms Texas, Inc. is recalling specific pepper fajita mix products due to a potential for contamination by Salmonella. The products were distributed in Texas, Oklahoma, Kansas, and Missouri.
Product
Taylor Farms Foodservice Pepper Fajita Mix (Pepper Green /Pepper Red/Onion Yellow) 3/8" Pack Size 4/5#; Taylor Farms Foodservice Pepper Blend 25% Green, 15% Red, 60% Onion Yellow Pack Size 2/5 #; Taylor Farms Foodservice Pepper Red & Green Blend & Onion Yellow Fajita Cut 3/8" Pa
Category
Food
Distribution
4 states
HighFDA (Food)·F-1340-2020·2020-09-09
Taylor Farms Recalls Marketside Diced Mirepoix Mix for Salmonella Risk
Taylor Farms Texas, Inc. is recalling Marketside Diced Mirepoix Mix due to a potential for contamination by Salmonella. The product was distributed in Texas, Oklahoma, Kansas, and Missouri.
Product
Marketside Diced Mirepoix Mix 6/10 oz
Category
Food
Distribution
4 states
HighFDA (Food)·F-1401-2020·2020-09-09
Giant Eagle Recalls Vegetable Pizza Slices for Potential Salmonella Contamination
Giant Eagle is recalling vegetable pizza slices sold in five states due to potential Salmonella Newport contamination in onions.
Product
VEGETABLE PIZZA SLICE (INDEPENDENT PLU) PLU# 25086400000. Expiration date 8/5/2020. Ingredients: VEGETABLE PIZZA [SPREAD (CREAM CHEESE [PASTEURIZED CULTURED MILK & CREAM, SALT, STABILIZERS (XANTHAN, CAROB BEAN, AND/OR GUAR GUMS)], MAYONNAISE [SOYBEAN OIL, WATER, EGGS, EGG YOLKS,
Category
Food
Distribution
5 states
HighFDA (Food)·F-1385-2020·2020-09-09
Giant Eagle Greek Salad Recalled for Potential Salmonella Newport Contamination
Giant Eagle is recalling MD G&G Greek Salad due to potential contamination with Salmonella Newport in onions. Consumers should not eat the product.
Product
MD G&G Greek Salad PLU#23662500000. Expiration date 8/4/2020. Ingredients: SALAD [ROMAINE LETTUCE, PEPPERONCINI (PEPPERS, WATER, SALT, VINEGAR, CITRIC ACID, SODIUM BENZOATE (AS PRESERVATIVE), SODIUM BISULFITE (TO ENHANCE COLOR), FD&C YELLOW #5), BALSAMIC VINAIGRETTE (SEE DRESSING
Category
Food
Distribution
5 states
HighFDA (Food)·F-1398-2020·2020-09-09
Giant Eagle Recalls Spanikopita Due to Potential Salmonella Newport Contamination
Giant Eagle is recalling Spanikopita with expiration date 8/6/2020 due to potential contamination with Salmonella Newport in onions.
Product
SPANIKOPITA (INDEPENDENT PLU).PLU# 25070900000. Expiration date 8/6/2020. Ingredients: SPANIKOPITA [CHOPPED SPINACH, EGG, SALTED BUTTER [PASTEURIZED CREAM, SALT], PASTRY DOUGH [ENRICHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, C
Category
Food
Distribution
5 states
HighFDA (Food)·F-1355-2020·2020-09-09
Whole Foods Market Artequeso Manchego Cheese Recalled for Undeclared Egg
Whole Foods Market is recalling Artequeso Manchego cheese due to undeclared lysozyme from egg whites, a common allergen.
Product
Whole Foods Market Artequeso Manchego 6 month aged raw Raw Milk - Aged 60 days or more PLU 20057900000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1392-2020·2020-09-09
Giant Eagle Recalls 22-Inch Italian Hoagies Due to Salmonella Risk
Giant Eagle is recalling 22-inch Italian Hoagies sold in five states due to potential Salmonella Newport contamination in onions.
Product
22INCH ITALIAN HOAGIE (INDEPENDENT PLU) PLU# 25049300000. Expiration date 8/2/2020. Ingredients: 22" ITALIAN HOAGIE [COUNTRY FRENCH BREAD [DOUGH [ENRICHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER,
Category
Food
Distribution
5 states
HighFDA (Food)·F-1382-2020·2020-09-09
Giant Eagle Recalls Greek Salad Due to Salmonella Newport Contamination
Giant Eagle is recalling Large Greek Salads with an expiration date of 8/3/2020 due to potential contamination with Salmonella Newport in onions.
Product
Greek Salad Large PLU#22667100000. Expiration date:8/3/2020. Ingredients: SALAD [ROMAINE LETTUCE, BUTTERMILK RANCH (SEE DRESSING CUP), GRAPE TOMATOES, BACON BITS (BACON CURED WITH: WATER, SALT, SODIUM PHOSPHATES, SODIUM ERYTHORBATE, SODIUM NITRITE, MAY CONTAIN: SUGAR, BROWN SUGAR
Category
Food
Distribution
5 states
HighFDA (Food)·F-1397-2020·2020-09-09
Giant Eagle Recalls Homemade Macaroni Salad Due to Salmonella Risk
Giant Eagle is recalling homemade macaroni salad sold in Giant Eagle and Market District locations due to potential Salmonella Newport contamination in raw onions.
Product
HOMEMADE MACARONI SALAD (INDEPENDENT PLU) PLU# 25067800000. Expiration date 8/6/2020. Ingredients: HOMEMADE MACARONI SALAD [MACARONI (WATER, MACARONI [ENRICHED DURUM WHEAT SEMOLINA (FERROUS SULFATE, NIACIN, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID)], OIL BLEND [CANOLA OIL, E
Category
Food
Distribution
5 states
HighCPSC·20179·2020-09-09
Cannondale Treadwell Front Racks Recalled Due to Fall Hazard
Cycling Sports Group is recalling front racks for Cannondale Treadwell bicycles because they can detach and cause falls.
Product
Front Racks with Bamboo Trays
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·20177·2020-09-09
WHILL Recalls Model Ci Electric Vehicles Due to Control Malfunction
WHILL is recalling about 1,160 Model Ci personal electric vehicles because a control pad malfunction can cause unintended power changes and speed fluctuations, posing crash and injury hazards.
Product
WHILL Personal Electric Vehicles, Model Ci
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2921-2020·2020-09-09
Siemens Sensis Vibe Hemo System Recalled for Connector Defect
Siemens is recalling 110 Sensis Vibe Hemo systems because a connector may break, potentially causing the device to stop functioning and lose vital signs.
Product
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2915-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2917-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1394-2020·2020-09-09
Giant Eagle Recalls Cheeseburger Pizza Slices for Salmonella Risk
Giant Eagle is recalling Cheeseburger Pizza Slices with an expiration date of 8/4/2020 due to potential Salmonella Newport contamination in onions.
Product
CHEESEBURGER PIZZA SLICE (INDEPENDENT PLU) PLU# 25060700000. Expiration date 8/4/2020. Ingredients: CHEESEBURGER PIZZA [DOUGH SHELL [ENRICHED FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, YEAST, SOYBEAN OIL, <
Category
Food
Distribution
5 states
HighFDA (Food)·F-1379-2020·2020-09-09
Giant Eagle Recalls MD BLT Salad for Potential Salmonella Newport Contamination
Giant Eagle is recalling MD BLT Salad with an expiration date of 8/4/2020 due to potential contamination with Salmonella Newport in onions.
Product
MD BLT Salad PLU#22660900000. Expiration date 8/4/2020.Ingredients: SALAD [ROMAINE LETTUCE, BUTTERMILK RANCH (SEE DRESSING CUP), GRAPE TOMATOES, BACON BITS (BACON CURED WITH: WATER, SALT, SODIUM PHOSPHATES, SODIUM ERYTHORBATE, SODIUM NITRITE, MAY CONTAIN: SUGAR, BROWN SUGAR, AND/
Category
Food
Distribution
5 states
HighFDA (Food)·F-1356-2020·2020-09-09
Whole Foods Market La Marquesa Herb Manchego Raw Milk Cheese Recalled for Undeclared Egg
Whole Foods Market is recalling La Marquesa Herb Manchego Raw Milk cheese because it contains undeclared egg whites (lysozyme).
Product
Whole Foods Market La Marquesa Herb Manchego Raw Milk - Aged 60 days or More PLU 29399800000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1403-2020·2020-09-09
Giant Eagle Recalls Sheet Vegetable Pizza for Potential Salmonella Newport Contamination
Giant Eagle is recalling sheet vegetable pizza sold in five states due to potential contamination with Salmonella Newport in onions.
Product
SHEET VEGETABLE PIZZA (INDEPENDENT PLU) PLU# 25086800000. Expiration date 8/5/2020. Ingredients: VEGETABLE PIZZA [SPREAD (CREAM CHEESE [PASTEURIZED CULTURED MILK & CREAM, SALT, STABILIZERS (XANTHAN, CAROB BEAN, AND/OR GUAR GUMS)], MAYONNAISE [SOYBEAN OIL, WATER, EGGS, EGG YOLKS,
Category
Food
Distribution
5 states
HighFDA (Food)·F-1395-2020·2020-09-09
Giant Eagle Recalls Philly Steak Pizza Slices for Salmonella Risk
Giant Eagle is recalling Philly Steak Pizza Slices due to potential Salmonella Newport contamination in onions. Consumers should not eat the product.
Product
PHILLY STEAK PIZZA SLICE (INDEPENDENT PLU) PLU# 25061200000. Expiration date 8/4/2020. Ingredients: PHILLY STEAK PIZZA [DOUGH SHELL [ENRICHED FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, YEAST, SOYBEAN OIL, <
Category
Food
Distribution
5 states
HighFDA (Food)·F-1415-2020·2020-09-09
Giant Eagle Zucchini Pancakes Recalled for Potential Salmonella Newport Contamination
Giant Eagle is recalling Zucchini Pancakes due to potential contamination with Salmonella Newport in onions. Consumers should check expiration dates and discard affected products.
Product
ZUCHINNI PANCAKES PLU#28659400000. Expiration date 8/6/2020. Ingredients: ZUCCHINI CAKES [ZUCCHINI, EGGS (WHOLE EGG, CITRIC ACID [TO PRESERVE COLOR], WATER), YELLOW ONION, FLOUR (BLEACHED WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FO
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2919-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1388-2020·2020-09-09
Giant Eagle Recalls Cajun Style Chicken Meal for Salmonella Risk
Giant Eagle is recalling Cajun Style Chicken Meal due to potential contamination with Salmonella Newport in onions. The product was sold in several states.
Product
Cajun Style Chicken Meal PLU# 24658700000. Expiration date 8/5/2020.Ingredients: MEAL [CAJUN STYLE BOWTIE PASTA (BOWTIE PASTA (COOKED ENRICHED MACARONI PRODUCT [WATER, SEMOLINA, EGG WHITES, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID], SOYBEAN OIL, CONTAI
Category
Food
Distribution
5 states
HighFDA (Food)·F-1412-2020·2020-09-09
Giant Eagle Egg and Bacon Salad Recalled for Salmonella Newport Risk
Giant Eagle is recalling MD Egg & Bacon Salad with Lite Balsamic Dressing due to potential Salmonella Newport contamination in onions.
Product
MD EGG & BACON SALAD WITH LITE BALSAMIC DRESS PLU#27665100000. Expiration date 8/4/2020. Ingredients: SALAD [ROMAINE LETTUCE, DRESSING (WATER, DISTILLED VINEGAR, BALSAMIC VINEGAR, OLIVE OIL, VEGETABLE OIL [SOYBEAN AND/OR CANOLA], SUGAR, SALT, CONTAINS LESS THAN 2% OF DRIED GARLI
Category
Food
Distribution
5 states
HighFDA (Food)·F-1384-2020·2020-09-09
Giant Eagle Recalls Greek Salad for Potential Salmonella Contamination
Giant Eagle is recalling MD Greek Salad with Greek Dressing due to potential Salmonella Newport contamination in onions. Consumers in five states should discard the product.
Product
MD Greek Salad with Greek Dressing PLU#23660700000. Expiration date:8/4/2020. Ingredients: SALAD [ROMAINE LETTUCE, PEPPERONCINI (PEPPERS, WATER, SALT, VINEGAR, CITRIC ACID, SODIUM BENZOATE (AS PRESERVATIVE), SODIUM BISULFITE (TO ENHANCE COLOR), YELLOW 5), VINAIGRETTE (WATER, VEGE
Category
Food
Distribution
5 states
HighFDA (Food)·F-1408-2020·2020-09-09
Giant Eagle Cold Italian Hero Recalled for Salmonella Newport Risk
Giant Eagle is recalling Cold Italian Hero sandwiches due to potential Salmonella Newport contamination in onions. Consumers in five states should discard the product.
Product
COLD ITALIAN HERO, 12" (INDEPENDENT PLU) PLU#25118500000. Expiration date 8/2/2020. Ingredients: 12" COLD ITALIAN HERO [BUN [ENRICHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, 2% OR LESS OF YEAST, S
Category
Food
Distribution
5 states
HighFDA (Food)·F-1418-2020·2020-09-09
Giant Eagle Recalls California Cobb Salads Due to Salmonella Risk
Giant Eagle is recalling California Cobb salads due to potential Salmonella Newport contamination in onions. Consumers should not eat the product.
Product
CALIFORNIA COBB - SMALL PLU#29690000000 . Expiration date 8/4/2020. Ingredients: OBB SALAD [ROMAINE LETTUCE, DICED GRILLED CHICKEN (CHICKEN BREAST [BONELESS SKINLESS CHICKEN BREAST], WATER, ISOLATED SOY PROTEIN, SALT, KIWI, SODIUM PHOSPHATES, BLACK PEPPER), AVOCADOS, EGG, TOMATO
Category
Food
Distribution
5 states
HighFDA (Food)·F-1391-2020·2020-09-09
Giant Eagle Recalls Stuffed Balls for Potential Salmonella Newport Contamination
Giant Eagle is recalling Stuffed Balls due to potential contamination with Salmonella Newport in onions. The product was sold in Indiana, Ohio, Maryland, West Virginia, and Pennsylvania.
Product
STUFFING BALLS S0678/1602 (INDEPENDENT PLU) PLU# 25048600000. Expiration date 8/6/2020. Ingredients: STUFFING BALLS [STUFFING BALL [SPREAD (PURIFIED WATER, SOYBEAN OIL, PALM KERNEL & PALM OIL, SALT, SOY LECITHIN, VINEGAR, NATURAL FLAVORS, VITAMIN A PALMITATE, BETA CAROTENE [COLOR
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2918-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2935-2020·2020-09-09
CareFusion Recalls BD Alaris EtCO2 Modules Due to Monitoring Interruption Risk
CareFusion 303, Inc. is recalling 680 BD Alaris EtCO2 modules because a component defect may interrupt patient monitoring.
Product
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1526-2020·2020-09-09
Frito-Lay Recalls Ruffles Potato Chips for Undeclared Milk
Frito-Lay is recalling 768 bags of Ruffles Original Potato Chips in Washington and Oregon due to a potential undeclared milk allergen.
Product
Ruffles Original Potato Chips NET WT 1 1/2 oz. packaged in flexible bags UPC 28400 48228
Category
Food
Distribution
2 states
HighFDA (Food)·F-1377-2020·2020-09-09
Giant Eagle Recalls Farmers Salad Due to Salmonella Newport Contamination
Giant Eagle is recalling Farmers Salad with an expiration date of 8/6/2020 due to potential contamination with Salmonella Newport in onions.
Product
Farmers Salad PLU#22658400000. Expiration date 8/6/2020. Ingredients: SALAD [CUCUMBER, PITTED KALAMATA OLIVES [PITTED OLIVES (OLIVES, WATER, SALT, OLIVE OIL, ACETIC ACID), CANOLA OIL, SPICES], RED ONION, GREEN BELL PEPPER, RED BELL PEPPER, YELLOW BELL PEPPERS, GRAPE TOMATOES, VIN
Category
Food
Distribution
5 states
HighFDA (Food)·F-1387-2020·2020-09-09
Giant Eagle Philly Style Steak Stromboli Recalled for Salmonella Risk
Giant Eagle is recalling Philly Style Steak Stromboli products due to potential contamination with Salmonella Newport in onions.
Product
MD Philly Style Steak Stromboli Cold PLU#23676600000. Expiration date: 8/3/2020 Ingredients: STROMBOLI [DOUGH (ENRICHED WHEAT FLOUR [WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID], WATER, ENRICHED SEMOLINA FLOUR [SEMOLINA, NI
Category
Food
Distribution
5 states
HighFDA (Food)·F-1374-2020·2020-09-09
Giant Eagle Spinach Salad Ranch Dressing Recalled for Salmonella Risk
Giant Eagle is recalling Spinach Salad Ranch Dressing due to potential Salmonella Newport contamination in onions.
Product
Spinach Salad Ranch Dressing PLU#21738800000 Expiration date 8/5/2020. Ingredients:SALAD [RANCH DRESSING (SOYBEAN OIL, CULTURED BUTTERMILK, WATER, MALTODEXTRIN, DISTILLED VINEGAR, EGG YOLK, CONTAINS LESS THAN 2% OF SALT, SUGAR, DRIED GARLIC, BUTTERMILK SOLIDS, LACTIC ACID, SPICE,
Category
Food
Distribution
5 states
HighFDA (Food)·F-1354-2020·2020-09-09
Whole Foods Market Recalls Sliced Cheese for Undeclared Egg Allergen
Whole Foods Market is recalling specific sliced cheeses due to undeclared lysozyme from egg whites, posing a risk to individuals with egg allergies.
Product
Whole Foods Market El Trigal 12 Month Old Manchego PLU 29329500000; Whole Foods Market El Trigal 6 Month Old Manchego PLU 29329900000; Whole Foods Market Mitica Cordobes PLU 29335700000; Individual sliced cheese wrapped in plastic wrap with scale label on top.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2912-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes or tears at the cuffs, compromising barrier protection.
Product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2913-2020·2020-09-09
Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
Product
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1503-2020·2020-09-09
Sundial Ethiopian Traditional Talba Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Ethiopian Traditional Talba (Flaxseed Meal Cereal) because it is misbranded and deemed an unapproved drug based on its labeling claims.
Product
"SUNDIAL***Ethiopian Traditional Talba (Flaxseed Meal Cereal)***"
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1497-2020·2020-09-09
Sundial Herbal Formula Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling its Traditional Herbal Formula for Flu-Allergies HayFever because the product is misbranded and deemed an unapproved drug.
Product
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1459-2020·2020-09-09
Sundial Marsh Marigold Herbal Product Recalled for Misbranding
Sundial Herbal Products is recalling Marsh Marigold herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MARSH MARIGOLD***1 oz.***USES: LIVER AILMENTS, HEPATITIS***"; packaged in clear plastic zip-top bags.
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1494-2020·2020-09-09
Sundial Herbal Blood Pressure Formula Recalled for Misbranding and Unapproved Drug Status
Sundial Herbal Products is recalling Sundial Traditional Herbal Formula Blood Pressure boxes under a permanent injunction. The products are misbranded and deemed unapproved drugs due to labeling claims.
Product
"SUNDIAL***TRADITIONAL HERBAL FORMULA***BLOOD PRESSURE***" packaged in boxes
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1464-2020·2020-09-09
Sundial Cinnamon Herbal Product Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling 1 oz. bags of Cinnamon under a permanent injunction because the product is misbranded and deemed an unapproved drug.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CINNAMON***1 oz.***USES: STOMACH PAIN, MUCOUS CONGESTION, COLDS, NOSE BLEED, STIMULANT, FLAVORING***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1487-2020·2020-09-09
Sundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Bread Nut herbal products under a permanent injunction because the labeling makes unapproved drug claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1480-2020·2020-09-09
Sundial White Sage Herbal Product Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling White Sage herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE SAGE***2 oz.***USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1449-2020·2020-09-09
Sundial Mahogany Bark Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Mahogany Bark herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Product
SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1465-2020·2020-09-09
Sundial African Fever Bush Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling African Fever Bush under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1478-2020·2020-09-09
Sundial Trumpet Leaf Herbal Product Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Trumpet Leaf herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***TRUMPET LEAF***1 oz.***USES: DIABETES, ASTHMA, CONGESTION, SKIN BATH, ULCERS, SORES, PARKINSON'S DISEASE, KIDNEY***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2936-2020·2020-09-09
Diasorin Recalls Parvovirus B19 IgG EIA Kit Due to Labeling Error
Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit because the printed label inside the box lid contains an incorrect Lot Specific Constant value.
Product
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2926-2020·2020-09-09
Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error
Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.
Product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Category
Medical Device
Distribution
4 states
ModerateFDA (Food)·F-1452-2020·2020-09-09
Sundial Bay Leaves Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling bay leaves labeled with unapproved drug claims. The FDA determined the products are misbranded and unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BAY LEAVES***1 oz.***USES: COUGH, COLD, DIABETES, ACHES, PAINS, DIGESTION, FEVER, FLU SYMPTOMS***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-1569-2020·2020-09-09
AAA Cosmetica Recalls bio aaa Advance Hand Sanitizer Due to CGMP Deviations
AAA Cosmetica is voluntarily recalling 21,228 bottles of bio aaa Advance Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.
Product
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1558-2020·2020-09-09
Grato Holdings Recalls HGH Vitality Homeopathic Tablets Due to Labeling Error
Grato Holdings, Inc. is recalling 850 bottles of HGH Vitality Homeopathic tablets due to an error on the declared strength.
Product
HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1476-2020·2020-09-09
Sundial Purple Sage Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Purple Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1455-2020·2020-09-09
Sundial Devil Horsewhip Herbal Product Recalled for Misbranding
Sundial Herbal Products is recalling Devil Horsewhip herbal products under a court order because the items are misbranded and considered unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1491-2020·2020-09-09
Sundial African Manback Tonic Recalled for Misbranding and Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Traditional African Manback Tonic because the product is misbranded and deemed an unapproved drug based on its labeling claims.
Product
"SUNDIAL***TRADITIONAL AFRICAN MANBACK TONIC***remember the strength of the reproductive organ, reflects the strength of the entire body. Take SUNDIAL AFRICAN MANBACK TONIC to strengthen, rejuvenate & energize***" packaged in glass bottles
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1458-2020·2020-09-09
Sundial Herbal Products Recalls Misbranded Sarsaparilla Herbal Product
Sundial Herbal Products is recalling Sarsaparilla herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SARSAPARILLA***2 oz.***USES: BLOOD CLEANSER, BALANCES HORMONES, PRODUCTIVE ORGANS, SYPHILIS, ECZEMA, PSORIASIS***"; packaged in clear plastic zip-top bags.
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-2931-2020·2020-09-09
Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component
Stimwave Technologies is recalling six StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.
Product
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elec
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1482-2020·2020-09-09
Sundial Guava Leaf Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Guava Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUAVA LEAF***1oz.***USES: BLOOD PRESSURE, WORMS, NERVES, DIABETES***"; packaged in clear plastic zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1471-2020·2020-09-09
Sundial Fig Leaf Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Fig Leaf herbal products under a permanent injunction because the labeling makes unapproved drug claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***FIG LEAF***1oz.***USES: FIBER, CALCIUM, DIABETES, HIGH BLOOD PRESSURE, GENITAL WARTS, LIVER, ULCERS***"; packaged in clear zip-top bags
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1468-2020·2020-09-09
Sundial Fever Grass Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Fever Grass herbal products under a court order because the labels make unapproved drug claims.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***FEVER GRASS***1oz.***USES: FEVER, COLD, MALARIA, FLU, COUGH, PNEUMONIA, HEADACHE, NERVES, STOMACH & BOWEL***"; packaged in clear plastic zip-top bags
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1364-2020·2020-09-09
Newman's Own Organic Decaf Coffee Recalled for Containing Non-Organic Beans
Keurig Dr Pepper is recalling Newman's Own Organic Decaf Ground Coffee because it contains regular non-organic coffee. Consumers should stop using the product.
Product
Newman's Own Organics, Newman's Special Decaf Medium Roast, Ground Coffee, 10 oz.
Category
Food
Distribution
5 states
ModerateFDA (Food)·F-1443-2020·2020-09-09
Sundial Organic Jamaican Turmeric Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Sundial Organic Jamaican Turmeric because the product is misbranded and deemed an unapproved drug due to labeling claims.
Product
SUNDIAL ORGANIC JAMAICAN TUMERIC; "***increases the quality and quantity of breast milk***suppresses the development of parasite that causes tumors cancer, growths, cysts & all types of cancers***"
Category
Food
Distribution
1 state

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