The Recall Desk

Archive

September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical
56
Severe
156
High
252
Moderate
154
Low
13

Of the 631 recalls this month scored against our rubric, 9% are Critical, 25% are Severe.

301–400 of 631

  • SevereFDA (Food)·F-1359-2020·2020-09-09

    Whole Foods Market Recalls Forteto Genovese Pesto Cheese for Undeclared Egg

    Whole Foods Market is recalling Forteto Genovese Pesto cheese nationwide due to undeclared egg whites (lysozyme). Consumers with egg allergies should not eat the product.

    Product
    Whole Foods Market IL FORTETO Genovese Pesto PLU 20017100000 Individual sliced cheese wrapped in plastic wrap with scale label on top.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1365-2020·2020-09-09

    Giant Eagle Recalls Red Onions for Potential Salmonella Newport Contamination

    Giant Eagle is recalling Sub Shop Red Onions due to potential Salmonella Newport contamination. Consumers should not eat the product and should return it to the store.

    Product
    Sub Shop-Red Onions. Expiration 7/31/2020. Ingredients raw red onion.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (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…
    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-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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1573-2020·2020-09-09

    Skin Guard 24 Hand Sanitizer Recalled for Unapproved Methanol Content

    SG24 LLC is recalling Skin Guard 24 All-Day Hand Sanitizer pens because they are labeled to contain methanol, making them unapproved new drugs.

    Product
    Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • 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…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1393-2020·2020-09-09

    Giant Eagle Recalls 12-Inch Italian Hoagies Due to Salmonella Risk

    Giant Eagle is recalling 12-inch Italian Hoagies with an expiration date of 8/2/2020 due to potential Salmonella Newport contamination in onions.

    Product
    SPECIALTY 12" ITALIAN HOAGIE (INDEPENDENT PLU) PLU# 25049400000. Expiration date 8/2/2020. Ingredients: 12" ITALIAN HOAGIE [ITALIAN SUB ROLL [ENRICHED FLOUR (UNBLEACHED UNBROMATED WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, YEAST…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (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
  • 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…
    Category
    Food
    Distribution
    5 states
  • 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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1572-2020·2020-09-09

    SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content

    SG24 LLC is recalling SkinGuard 24 Hand Sanitizer because it is an unapproved new drug containing methanol.

    Product
    SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1372-2020·2020-09-09

    Giant Eagle Recalls MD Caprese Salad Due to Salmonella Risk

    Giant Eagle is recalling MD Caprese Salad with an expiration date of 8/4/2020 due to potential Salmonella Newport contamination in onions.

    Product
    MD Caprese Salad PLU#21660900000. Expiration date 8/4/2020. Ingredients:SALAD [ROMAINE LETTUCE, MOZZARELLA CHEESE (PASTEURIZED MILK, VINEGAR, ENZYMES, SALT), GRAPE TOMATOES, BALSAMIC VINAIGRETTE (SEE DRESSING CUP), SPRING MIX (GREEN LEAVES [FRISEE, WILD ARUGULA, MACHE], RED…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (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
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1370-2020·2020-09-09

    Giant Eagle Vegetable Medley Salad Recalled for Salmonella Newport Risk

    Giant Eagle is recalling Vegetable Medley Salad due to potential contamination with Salmonella Newport in onions.

    Product
    Vegetable Medley Salad PLU# 20686300000. Expiration date 8/3/2020. Ingredients:VEGETABLE MEDLEY SALAD (CELERY, LEMON JUICE [FILTERED WATER, LEMON JUICE CONCENTRATE, SODIUM BISULFITE (PRESERVATIVE), SODIUM BENZOATE (PRESERVATIVE), LEMON OIL], RADISHES, CUCUMBER, ONIONS, YELLOW…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (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…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1467-2020·2020-09-09

    Sundial Blood Leaf Herbal Product Recalled as Unapproved Drug

    Sundial Herbal Products is recalling Blood Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1335-2020·2020-09-09

    Triple B Corporation Recalls Peeled Onions Due to Salmonella Newport Risk

    Triple B Corporation is recalling Charlie's Produce peeled onions due to potential Salmonella Newport contamination. The product was distributed in Alaska.

    Product
    Charlies Produce Anchorage, WHITE 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…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1423-2020·2020-09-09

    Spokane Produce Recalls Salsa Verde Due to Salmonella Newport Risk

    Spokane Produce, Inc. is recalling specific Salsa Verde products due to potential contamination with Salmonella Newport. The affected items were distributed in Idaho, Montana, and Washington.

    Product
    Saddlin' Up Salsa Verde, item number 84032, refrigerated product, ready to eat product, packaged in a 15 oz plastic tub with a plastic lid. UPC 88694 84032. Salsa Verde, item number 84044, refrigerated product, ready to eat product,, packaged in a 1 gallon plastic container…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (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
  • SevereNHTSA·20V547000·2020-09-09

    Jayco Recalls 2019-2020 Motorhomes Due to Electrical Fire Risk

    Jayco is recalling 2019-2020 Entegra Reatta, Jayco Embark, and Entegra ReattaXL motorhomes because a damaged circuit board could increase the risk of a fire.

    Product
    ENTEGRA — ENTEGRA, JAYCO REATTA, EMBARK, REATTA XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereNHTSA·20V548000·2020-09-09

    Jayco Recalls Motorhomes Due to Leveling System Bracket Failure Risk

    Jayco is recalling specific 2016-2019 motorhomes because leveling system brackets may fail, causing components to contact the ground and increasing crash risk.

    Product
    JAYCO — JAYCO, ENTEGRA GREYHAWK PRESTIGE, REDHAWK, GREYHAWK, redundant ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E065000·2020-09-09

    Horizon Global Recalls U-Haul, Draw-Tite, and Reese Towpower Trailer Hitches

    Horizon Global is recalling specific U-Haul, Draw-Tite, and Reese Towpower trailer hitches sold between November 2019 and August 2020 due to a defect that may prevent the pintle hook from locking securely.

    Product
    TRAILER HITCHES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1337-2020·2020-09-09

    Triple B Corporation Recalls Charlies Produce Peeled Onions Due to Salmonella Risk

    Triple B Corporation is recalling Charlies Produce peeled onions due to potential Salmonella Newport contamination. The product was distributed in Alaska.

    Product
    Charlies Produce Anchorage, YELLOW 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 Charlies Produce 9401 King St., Anchorage, AK…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1485-2020·2020-09-09

    Sundial Herbal Products Recalls Palo De Brazil Wood Under FDA Injunction

    Sundial Herbal Products is recalling Palo De Brazil Wood in New York because the product is misbranded and deemed an unapproved drug.

    Product
    "***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
    Category
    Drug
    Distribution
    1 state
  • 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-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…
    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 (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
  • 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
  • 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-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-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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    5 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-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…
    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"…
    Category
    Food
    Distribution
    4 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].…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    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…
    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…
    Category
    Food
    Distribution
    5 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    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…
    Category
    Medical Device
    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-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…
    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…
    Category
    Food
    Distribution
    5 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…
    Category
    Food
    Distribution
    5 states
  • 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…
    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 (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…
    Category
    Medical Device
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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…
    Category
    Food
    Distribution
    5 states
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1445-2020·2020-09-09

    FDA Recalls Sundial Herbal Bitter Kola for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Kola (Arogbo) in New York because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the Bacteria that causes them***strengthen…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1493-2020·2020-09-09

    Sundial Herbal Asthma Formula Recalled as Unapproved Drug

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Asthma because it is an unapproved drug with misbranded labeling.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1461-2020·2020-09-09

    Sundial Herbal Products Recalls Dog Blood Herbal Product for Misbranding

    Sundial Herbal Products is recalling Dog Blood herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DOG BLOOD***1 oz.***USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE***"; packaged in clear plastic zip-top bag
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2928-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,444 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1450-2020·2020-09-09

    Sundial Chaney Root Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Chaney Root herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHEUMATISM, ARTHRITIS
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1490-2020·2020-09-09

    Sundial Ashanti Weight Loss Product Recalled as Unapproved Drug

    Sundial Herbal Products is recalling Ashanti Weight Loss Energy Lifter and Appetite Suppresser because the product is misbranded and deemed an unapproved drug.

    Product
    "***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1501-2020·2020-09-09

    Sundial Herbal Products Recalls Cocoa Balls for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Cocoa Balls because the product is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1444-2020·2020-09-09

    Sundial Herbal Products Recalls Ethiopian Flax Seed Oil and Honey Blend

    Sundial Herbal Products is recalling Ethiopian Flax Seed Oil & Honey Blend because it is misbranded and deemed an unapproved drug.

    Product
    ETHIOPIAN FLAX SEED OIL & HONEY BLEND; "***clears bladder, kidney, urinary tract prostate womb and colon, sooths stomach, lowers cholesterol and blood pressure***DIST. BY: SUNDIAL HERBAL PRODUCTS***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1463-2020·2020-09-09

    Sundial Black Wiss Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Black Wiss 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***BLACK WISS***1 oz.***USES: REGULATES GLANDS, CLEANS JOINTS, INFLAMMATION, SUPPLIES ENERGY***"; packaged in clear plastic zip-top bags
    Category
    Food
    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 (Devices)·Z-2924-2020·2020-09-09

    Randox Pancreatic Amylase Reagents Recalled for Performance Failure

    Randox Laboratories is recalling specific batches of Pancreatic Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.

    Product
    Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • 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 (Devices)·Z-2923-2020·2020-09-09

    Randox Laboratories Recalls Amylase Reagents Due to Performance Failures

    Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.

    Product
    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1504-2020·2020-09-09

    Sundial Jamaican Raw Honey Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Jamaican & Tropical Raw Honey because it is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***Jamaican & Tropical Raw Honey***"
    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 (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 (Drugs)·D-1555-2020·2020-09-09

    Jaloma Antiseptic Hand Sanitizer Recalled for cGMP Deviations

    Laboratorios Jaloma is recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2020·2020-09-09

    C.A. Greiner HOLDEX Plastic Cannula Recalled for Sample Leakage

    C.A. Greiner & Sohne is recalling 390,000 units of HOLDEX Plastic Cannulas (Lot A19073FK) because sample may leak from the sleeve covering the needle.

    Product
    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1457-2020·2020-09-09

    Sundial Red Water Grass Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling Red Water Grass herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***RED WATER GRASS***1 oz.***USES: FEMALE PROBLEMS, FIBROIDS, INFERTILITY, HIGH BLOOD PRESSURE***" packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2929-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,550 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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

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