June 2021 recalls

771 recalls were announced in June 2021.

What the numbers show

Critical: 10
Severe: 106
High: 384
Moderate: 260
Low: 11

Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

Which agencies issued them

1–100 of 771

CriticalFDA (Drugs)·D-0634-2021·2021-06-30
PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients
PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.
Product
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0719-2021·2021-06-30
Banner Smoked Fish Inc. Mackerel Recalled for Listeria monocytogenes
Banner Smoked Fish Inc. brand cold-smoked mackerel is being recalled because it may be contaminated with Listeria monocytogenes, a pathogenic bacterium. The recall affects all lots and package sizes distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Mackerel (Cold Smoked) (Atlantic Mackerel, Salt, Sugar, Natural Hardwood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0734-2021·2021-06-30
Banner Smoked Fish Baked Salmon Salad Recall for Listeria
Banner Smoked Fish Inc. is recalling all lots of Baked Salmon Salad due to potential Listeria monocytogenes contamination. Consumers should not eat the product and should discard it or return it to the point of purchase.
Product
Banner Smoked Fish Inc. brand Baked Salmon Salad; Ingredients: Smoked Atlantic Salmon (salmon, salt, natural hardwood smoke), Mayonnaise (Egg Yolk, Soya Oil, Vinegar, Sugar, Salt, Mustard, Calcium Disodium EDTA), Panko (Wheat Flour, Sugar, Yeast, Soybean Oil, Salt), Salt, Spices,
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0735-2021·2021-06-30
Banner Smoked Fish Turbot Recall Due to Listeria Contamination
Banner Smoked Fish Inc. is recalling Vilatar International Inc. brand smoked turbot because the product may be contaminated with Listeria monocytogenes. The recall affects all lots and package sizes distributed across multiple U.S. states.
Product
Vilatar International Inc. brand Turbot; Salt, Natural Wood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0723-2021·2021-06-30
Banner Smoked Fish Inc. Dry White Fish Listeria Contamination Recall
Banner Smoked Fish Inc. is recalling all lots of its Dry White Fish product due to potential contamination with Listeria monocytogenes. The affected product was distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Dry White Fish; Ingredients: Fish, White Fish, Salt
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0739-2021·2021-06-30
Banner Smoked Fish Inc. Sliced Smoked Escolar Recall
Banner Smoked Fish Inc. is recalling all lots of Sliced Smoked Escolar due to potential Listeria monocytogenes contamination. The product is distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Sliced Smoked Escolar; Ingredients: Escolar (Fish), Salt, Sugar, Natural Wood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0765-2021·2021-06-30
Designed by Nature Infant Formula Base Mix Recalled for Nutrient Deficiency and Pathogen Risk
Designed by Nature Base Mix Formula is recalled because it lacks multiple nutrients required for infant formula and the manufacturer does not test for Cronobacter, a pathogen that can be dangerous to infants.
Product
Designed by Nature Base Mix Formula: .375 oz/11 g plastic pouch/ Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life. UPC: 0 19962 28411 3 www.designed-by-nature.com
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0720-2021·2021-06-30
Banner Smoked Fish Inc. Sjomga Salmon Recalled for Listeria Risk
Banner Smoked Fish Inc. is recalling all lots of Sjomga smoked salmon trout due to potential contamination with Listeria monocytogenes, a harmful bacterium that can cause serious illness.
Product
Banner Smoked Fish Inc. brand Sjomga (Salmon Trout, Salt, Sugar, Natural Wood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0724-2021·2021-06-30
Vilatar Seabass Smoked Fish Recall Due to Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of Vilatar brand Seabass seasoned with salt, garlic, and natural wood smoke due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple states.
Product
Vilatar brand Seabass; Salt, Garlic, Natural Wood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0708-2021·2021-06-30
Smoked Fish Products Recalled for Listeria monocytogenes Contamination
Banner Smoked Fish Inc. is recalling multiple brands of sliced pastrami-style smoked salmon due to potential contamination with Listeria monocytogenes. All lots and package sizes are affected.
Product
a.) Banner Smoked Fish Inc. Sliced Pastrami Style Nova (Salmon (fish), Salt, Sugar, Spices, Sodium Nitrite, Natural Wood Smoke) b.) Benzs brand Gourmet Smoked-Sliced Pastrami Style Nova (Salmon (fish), Salt, Sugar, Spices, Sodium Nitrite, natural Smoke) c.) Golden Taste bra
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0710-2021·2021-06-30
Benz's Kansas City BBQ Smoked Salmon recalled for Listeria contamination
Banner Smoked Fish Inc. is recalling all lots of Benz's Kansas City BBQ Pre-Sliced Smoked Salmon due to potential Listeria monocytogenes contamination. The product was distributed across multiple states.
Product
Benz's Kansas City BBQ Pre-Sliced Smoked Salmon (Farm raised Atlantic Salmon (astaxanthin color added to feed), spices, salt, sugar, natural hardwood smoke, sodium nitrite)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0713-2021·2021-06-30
Banner Smoked Fish Sliced Gravad Lox Recalled for Listeria
Banner Smoked Fish Inc. is recalling all lots of its Sliced Gravad Lox due to potential contamination with Listeria monocytogenes. Affected products were distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Sliced Gravad Lox (Salmon, Salt, Dill weed, Pepper, Natural Hardwood Smoke, Sodium Nitrite)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0741-2021·2021-06-30
Banner Smoked Fish Hot Smoked Ground Kingfish Meat Recall
Banner Smoked Fish Inc. is recalling all lots of Hot Smoked Ground Kingfish Meat due to potential contamination with Listeria monocytogenes. The product was distributed across multiple US states.
Product
Banner Smoked Fish Inc. brand Hot Smoked Ground Kingfish Meat; Ingredients: Kingfish, Salt, Natural Hardwood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0709-2021·2021-06-30
Benzs Brand Smoked Salmon Recalled for Listeria Risk
Benzs brand Everything Bagel Spice Pre-Sliced Smoked Salmon may be contaminated with Listeria monocytogenes. The product was distributed across multiple states, and consumers should not eat it.
Product
Benzs brand Everything Bagel Spice Pre-Sliced Smoked Salmon (Farm raised Atlantic Salmon (astaxanthin color added to feed), spices, salt, sugar, natural hardwood smoke, sodium nitrite)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0729-2021·2021-06-30
Banner Smoked Fish Inc. Pickled Herring Salad Listeria Contamination Recall
Banner Smoked Fish Inc. brand Pickled Herring Salad is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Pickled Herring Salad; Ingredients: Chopped Herring, Mayonnaise (Soya Oil, Egg Yolks, Vinegar, Sugar, Salt, Mustard), Apple Sauce (Apples, High Fructose Corn Syrup, Corn Syrup, Water), Onions, Salt, Acidic Acid, Matzo Meal (Flour, Water), Sodium Benz
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0711-2021·2021-06-30
Banner Smoked Fish Inc. Lox Products Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of its smoked lox products due to potential contamination with Listeria monocytogenes. Affected products were distributed across multiple states.
Product
a.) Banner Smoked Fish Inc. brand Finest Sliced (Salty) Lox (Salmon, Salt) b.) Banner Smoked Fish Inc. brand Whole (Salty) Lox; Ingredients: Salmon (fish), Salt c.) Chile Lox (Salty Salmon); Ingredients: Salmon, Salt, Fish
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0707-2021·2021-06-30
Smoked Salmon Products Recalled for Potential Listeria Contamination
Banner Smoked Fish Inc. and multiple private-label brands are recalling smoked salmon products due to potential Listeria monocytogenes contamination. Affected products are distributed across 17 US states.
Product
a.) Banner Smoked Fish Inc. brand Sliced Smoked Scotch Style Salmon (Salmon, Salt, Sugar, Natural Wood Smoke, Sodium Nitrite) b.) Banner Smoked Fish Inc. brand Naturally Smoked Nova Salmon Bagel Cuts (Salmon, Salt, Sugar, Sodium Nitrite, Natural Hardwood Smoke) c.) Westside
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0717-2021·2021-06-30
Banner Smoked Fish Hot Smoked Mackerel Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of its Hot Smoked Mackerel due to potential Listeria monocytogenes contamination. The product was distributed across 17 states.
Product
Banner Smoked Fish Inc. brand Hot Smoked Mackerel (Atlantic Mackerel, Salt, Natural Hardwood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0730-2021·2021-06-30
Banner Smoked Whitefish Meat Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of its Smoked Whitefish Meat due to potential contamination with Listeria monocytogenes. The product was distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Smoked Whitefish Meat; ING: Whitefish (Fish), Salt, Natural Wood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0718-2021·2021-06-30
Smoked Trout Recalled for Potential Listeria monocytogenes Contamination
Banner Smoked Fish Inc. is recalling smoked trout products that may be contaminated with Listeria monocytogenes. The recall affects all lots and package sizes distributed across 17 states.
Product
Trout (Trout (fish), Salt, Sugar, Natural Wood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0764-2021·2021-06-30
Designed by Nature Goat's Milk Formula Recalled for Nutrient Deficiencies
Designed by Nature LLC is recalling its Goat's Milk Formula due to nutrient deficiencies and lack of testing for Cronobacter, a pathogen particularly dangerous to infants. The product was distributed in the US through the firm's website.
Product
Designed by Nature Goat's Milk Formula: Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0740-2021·2021-06-30
Banner Smoked Fish Inc. Hot-Smoked Ground Amberjack Recalled for Listeria
Banner Smoked Fish Inc. is recalling all lots of its Hot-Smoked Ground Amberjack meat due to potential contamination with Listeria monocytogenes. Consumers should not eat the product.
Product
Banner Smoked Fish Inc. brand Hot-Smoked Ground Amberjack meat; Ingredients: Amberjack, Salt, Natural Hardwood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0728-2021·2021-06-30
Banner Smoked Fish Pickled Herring Fillets Recalled for Listeria
Banner Smoked Fish Inc. is recalling all lots of Pickled Herring Fillets due to potential contamination with Listeria monocytogenes. The product may be unsafe for consumption.
Product
Banner Smoked Fish Inc.; Pickled Herring Fillets / 100 Count; Ingredients: Herring, onions, sugar, acetic acid, spices, salt, 1/10 of 1% sodium benzoate and potassium sorbate
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0725-2021·2021-06-30
Banner Smoked Fish Inc. Pickled Lox Recalled for Listeria Contamination
Banner Smoked Fish Inc. brand Pickled Lox is being recalled because the product may be contaminated with Listeria monocytogenes. Consumers should not eat this product.
Product
Banner Smoked Fish Inc. brand Pickled Lox; Ingredients: Salmon (Fish), Water, Sugar, Onions, Glacial Acetic Acid, Spices, Salt
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0763-2021·2021-06-30
Designed by Nature Cow's Milk Formula Recalled for Nutrient Deficiency
Designed by Nature Cow's Milk Formula in 12 oz. plastic pouches is being recalled because it lacks multiple nutrients required for infant formula and may contain Cronobacter, a pathogen dangerous to infants.
Product
Designed by Nature Cow's Milk Formula: 12 oz. plastic pouch. Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life. UPC: 0 19962 28421 2
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0714-2021·2021-06-30
Banner Smoked Fish Inc. Sliced Gravlax Recall for Listeria Contamination
Banner Smoked Fish Inc. brand Sliced Gravlax is being recalled because it may be contaminated with Listeria monocytogenes. The recall affects all lots and package sizes currently in distribution across multiple U.S. states.
Product
Banner Smoked Fish Inc. brand Sliced Gravlax (Salmon (fish), Salt, Sugar, Dill, Pepper, Sodium Nitrite)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0742-2021·2021-06-30
Banner Smoked Fish Inc. Large Smoked Chubs Listeria Contamination Recall
Banner Smoked Fish Inc. is recalling all lots of its Large Smoked Chubs product due to potential contamination with Listeria monocytogenes. The product is distributed across multiple U.S. states.
Product
Banner Smoked Fish Inc., brand Large Smoked Chubs
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0712-2021·2021-06-30
Banner Smoked Fish Inc. Salmon Products Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling multiple smoked salmon products due to potential Listeria monocytogenes contamination. The recall affects products distributed across 17 states.
Product
a.) Irish Cured (Salmon, Salt, Sugar, Natural Woodsmoke) b.) Homarus brand Naturally Smoked Salmon Nova (Salmon (fish), salt, sugar, natural woodsmoke) c.) Banner Smoked Fish Inc. brand Kippered Salmon; Ingredients: Salmon (Fish), Salt, Sugar, Natural Wood Smoke) d.) Ban
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0731-2021·2021-06-30
Banner Smoked Fish Kippered Salmon Recalled for Listeria Contamination
Banner Smoked Fish, Inc. is recalling all lots of its Smoked Kippered Salmon Meat due to potential Listeria monocytogenes contamination. The product was distributed across multiple states.
Product
Banner Smoked Fish, Inc. brand Smoked Kippered Salmon Meat; ING: Salmon (Fish), Salt, Sugar, Natural Wood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0732-2021·2021-06-30
Banner Smoked Fish Herring Products Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling Herring Tid Bits and Whole Fillets in Clear Sauce due to potential Listeria monocytogenes contamination. The recall affects all lots and package sizes currently in distribution.
Product
a.) Banner Smoked Fish Inc. brand Herring Tid Bits in Clear Sauce; Ingredients: Herring, Onions, Acetic Acid, Spices, Salt, Sugar, 1/10 of 1% Sodium benzoate and potassium sorbate b.) Banner Smoked Fish Inc. brand Whole Fillets In Clear Sauce; Ingredients: Herring, Onions, Ace
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0722-2021·2021-06-30
Banner Smoked Fish Sable Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of its Sable (Black Cod) product due to potential contamination with Listeria monocytogenes. Affected products were distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Sable (Black Cod, (fish), salt, garlic, natural wood smoke, sodium nitrite as a preservative
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0736-2021·2021-06-30
Smoked Sable Fish Products Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling multiple brands of sliced sable (black cod) because the product may be contaminated with Listeria monocytogenes. All lots and package sizes are affected.
Product
a.) Supreme Fine Fish Products brand Fresh Sliced Sable; Ingredients: Sable, Salt & Natural Smoke Flavor b.) Banner Smoked Fish Inc. brand All Natural Sliced Sable; Ingredients: Wiled-Caught Alaskan Black Cod (Fish), salt, garlic, natural hardwood smoke c.) Benz s brand Gou
Category
Food
Distribution
17 states
SevereFDA (Drugs)·D-0633-2021·2021-06-30
PremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination
PremierZEN Gold 7000 capsules are recalled nationwide because the product contains undisclosed pharmaceutical ingredients Sildenafil and Tadalafil and was marketed without FDA approval.
Product
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0715-2021·2021-06-30
Banner Smoked Fish Lox Style Cold Smoked Steelhead Listeria Contamination Recall
Banner Smoked Fish Inc. is recalling New York Steelhead Hudson Valley Fisheries brand Lox Style Cold Smoked Steelhead because the product may be contaminated with Listeria monocytogenes. All lots and package sizes are affected.
Product
New York Steelhead Hudson Valley Fisheries brand Lox Style Cold Smoked Steelhead
Category
Food
Distribution
17 states
SevereFDA (Drugs)·D-0635-2021·2021-06-30
maXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants
The FDA is recalling maXXzen Platinum 12000 capsules distributed nationwide because the product was marketed without an approved application and contains undisclosed pharmaceutical ingredients (Sildenafil and Tadalafil).
Product
maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1863-2021·2021-06-30
Nitric Oxide Delivery System Dosing Deficiency During Console Transitions
GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0738-2021·2021-06-30
Banner Smoked Fish Inc. Smoked Brook Trout Recall for Listeria Contamination
Banner Smoked Fish Inc. is recalling all lots of Smoked Brook Trout due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple states.
Product
Banner Smoked Fish Inc. brand Smoked Brook Trout; Ingredients: Farm Raised Brook Trout, Salt, Natural Wood Smoke
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0726-2021·2021-06-30
Banner Smoked Fish Inc. Cream Sauce Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling cream sauce products because they may be contaminated with Listeria monocytogenes. The recall affects products distributed across multiple states.
Product
Banner Smoked Fish Inc., Cream Sauce; INGREDIENTS: Cultured Cream, Contains less than 2% of: modified food starch (corn), sodium tripolyphosphate, carrageenan, locust bean gum, guar gum, and less than 1% of sodium benzoate and potassium sorbate
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0721-2021·2021-06-30
Banner Smoked Fish White Fish Hot Smoked Recalled for Listeria
Banner Smoked Fish Inc. is recalling all lots of its White Fish (Hot Smoked) product due to potential contamination with Listeria monocytogenes. The product is distributed across multiple U.S. states.
Product
Banner Smoked Fish Inc. brand White Fish (Hot Smoked), (White Fish (fish), Salt, Sugar, Natural Wood Smoke)
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0727-2021·2021-06-30
Banner Smoked Fish Inc. Herring Products Recalled for Listeria Contamination
Banner Smoked Fish Inc. is recalling Herring Tid Bits In Cream and Herring Fillets In Cream due to potential Listeria monocytogenes contamination. All lots and package sizes are affected.
Product
a.) Banner Smoked Fish Inc.; Herring Tid Bits In Cream; INGREDIENTS: Herring, Sour Cream (Cultured pasteurized milk, cream, nonfat milk), onions, acetic acid, sugar, spices, salt, sodium benzoate, and potassium sorbate b.) Banner Smoked Fish Inc.; Herring Fillets In Cream; ING
Category
Food
Distribution
17 states
SevereFDA (Food)·F-0733-2021·2021-06-30
Smoked Whitefish Salad Recall Due to Listeria Contamination
Banner Smoked Fish Inc. is recalling Marshall's Best brand and Banner brand Smoked Whitefish Salad products because they may be contaminated with Listeria monocytogenes.
Product
a.) Marshall s Best brand Smoked Whitefish Salad; Ingredients: Smoked Whitefish (whitefish, salt, natural hardwood smoke), Mayonnaise (egg yok, soya oil, vinegar, sugar, salt, mustard, calcium disodium edta, Panko (Wheat Flour, Sugar, Yeast, Soybean Oil, Salt), Salt, Spice, Less
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-1938-2021·2021-06-30
OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings
Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.
Product
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1931-2021·2021-06-30
FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results
Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.
Product
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V493000·2021-06-30
2021 Porsche Cayenne steering column screw defect may cause loss of control
Porsche is recalling 2021 Cayenne vehicles because the screw connecting the steering column to the steering box may fail, potentially detaching the steering column and causing loss of vehicle control.
Product
PORSCHE — PORSCHE CAYENNE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0698-2021·2021-06-30
Clio Vanilla Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Vanilla Greek Yogurt Bars (50g x 10 pack, UPC 861703000106) due to the possible presence of metal fragments. The recall affects 196,863 cases distributed nationwide with best-by dates between February 14, 2021 and June 27, 2021.
Product
Clio Vanilla Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack. UPC code: 861703000106
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1926-2021·2021-06-30
reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access
Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.
Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Category
Medical Device
Distribution
16 states
HighFDA (Food)·F-0679-2021·2021-06-30
O'Brien's Own Gourmet Granola Recalled for Undeclared Milk
O'Brien's Own Gourmet Granola blueberry muffin flavor is recalled because the product contains whey but does not declare milk on the label, creating a risk for consumers with milk allergies.
Product
O'Brien's Own Gourmet Granola, blueberry muffin, Net Wt. 12 OZ , UPC 6 09132 49665 3, Manufactured and Distributed by O'Brien's Own Gourmet Granola, Center Point, IA.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0691-2021·2021-06-30
Clio Mixed Berry/Peach Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Mixed Berry/Peach Greek Yogurt Bars sold at Costco due to possible metal fragments in the product. Consumers should not consume the affected items.
Product
Clio Mixed Berry / Peach Greek Yogurt Bars wrapped in a Chocolate Coating Costco Club pack Clio 50g x 16 (12pc tray), UPC code: 854021008220
Category
Food
Distribution
Distributed nationwide
HighCPSC·21156·2021-06-30
Children's Nightgowns Recalled for Flammability Standard Violation
Auranso Official children's nightgowns sold on Amazon fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 8,000 units distributed January–June 2021 are affected.
Product
Children's Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0686-2021·2021-06-30
Clio Vanilla Greek Yogurt Mini Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Vanilla Greek Yogurt Mini Bars due to the possibility of metal fragments in the product. Consumers should not consume affected yogurt bars.
Product
Clio Vanilla Greek Yogurt Mini Bars wrapped in a Chocolate Coating 6.2oz pouch x 6 pouches per case, UPC: 854021008077
Category
Food
Distribution
Distributed nationwide
HighCPSC·21159·2021-06-30
Children's Robes Fail Federal Flammability Standards, Pose Burn Risk
SIORO-branded children's robes sold on Amazon from December 2020 through April 2021 fail to meet federal flammability standards for sleepwear, posing a risk of burn injuries to children.
Product
Children's Robes
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2021·2021-06-30
OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.
Product
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0703-2021·2021-06-30
Favorite Day Peanut Butter Monster Trail Mix Recall for Plastic Contamination
John B. Sanfilippo & Son Inc. is recalling Favorite Day Peanut Butter Monster Trail Mix because the product may contain stringy pieces of flexible plastic. The affected product was distributed nationwide.
Product
favorite day peanut butter monster Trail Mix, Product Number 04316. Peanuts, peanut butter chips, raisins, M&M'S peanut butter chocolate candies, peanut butter pretzel balls, and mini peanut butter cups. Net Wt 14 oz. (396g), UPC 85239-15684
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0697-2021·2021-06-30
Clio Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Vanilla and Strawberry Club pack Greek Yogurt Bars nationwide due to the possibility of metal fragments in the product. Consumers should not eat the affected bars.
Product
Clio Vanilla / Strawberry Club pack Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 12 , 16pc tray, 24g x 24 (12pc tray), 55g x 16 (8pc tray). UPC codes: 854021008121, 854021008138, and 854021008022
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2021·2021-06-30
Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Product
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21157·2021-06-30
Children's Nightgowns Recalled for Flammability Standard Violation
About 4,900 Booph children's nightgowns sold on Amazon from March through June 2021 are being recalled because they fail to meet federal flammability standards for sleepwear, posing a burn risk to children.
Product
Children's Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·21158·2021-06-30
UPPAbaby RumbleSeat Adapters Recalled for Child Fall Hazard
UPPAbaby is recalling approximately 86,000 RumbleSeat adapters that can detach from strollers, posing a fall hazard to children. The company has received 135 reports of detachments, including injuries such as bumps, scrapes, and two broken noses.
Product
UPPAbaby adapters included with Rumbleseats
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0693-2021·2021-06-30
Clio Peach Less Sugar Yogurt Bars recalled for possible metal fragments
Clio LLC is recalling Clio Peach Less Sugar Yogurt Bars due to the possible presence of metal fragments in the product. The 10-pack boxes with best buy dates between 2/7/2021 and 6/20/2021 were distributed nationwide.
Product
Clio Peach Less Sugar Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 854021008213
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0695-2021·2021-06-30
Clio Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Raspberry/Peach Sams Mini Club Yogurt Bars due to the possible presence of metal fragments. The recalled product was distributed nationwide.
Product
Clio Raspberry / Peach Sams Mini Club Yogurt Bars wrapped in a Chocolate Coating 24g x 24 (12pc tray), UPC code: 854021008251
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0690-2021·2021-06-30
Clio Honey Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Honey Greek Yogurt Bars due to the possibility of metal fragments in the product. The recall affects 5,423 cases distributed nationwide with best-by dates between March 7, 2021 and July 11, 2021.
Product
Clio Honey Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 861703000168
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2021·2021-06-30
Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.
Product
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-0688-2021·2021-06-30
Clio Coconut Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Coconut Less Sugar Yogurt Bars (45g and 50g 10-packs) distributed nationwide due to possible metal fragments in the product.
Product
Clio Coconut Less Sugar Yogurt Bars wrapped in a Chocolate Coating 45g x 10 Clio Retail 10-pack and 50g x 10 Clio Retail 10-pack, UPC codes: 854021008237 and 854021008046
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1904-2021·2021-06-30
Philips Allura Xper System power supplies may fail unexpectedly
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
Product
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1914-2021·2021-06-30
Ultrasonic Probe Covers Lack FDA Clearance for Body Use
Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.
Product
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1919-2021·2021-06-30
Ultrasound Probe Cover Kit Recalled for Lack of FDA Clearance
Exact Medical Manufacturing is recalling the Hays Innovation Ultrasound Probe Cover Kit because it lacks required FDA 510(k) clearance for use in body openings.
Product
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-0680-2021·2021-06-30
O'Brien's Own Gourmet Granola Recalled for Undeclared Milk
O'Brien's Own Gourmet Granola (busy bee's honey & oat, 12 OZ) is being recalled because the product contains whey but does not declare milk on the label. Consumers with milk allergies or sensitivities are at risk.
Product
O'Brien's Own Gourmet Granola, busy bee's honey & oat, Net Wt. 12 OZ , UPC 6 09132 49667 7; Manufactured and Distributed by O'Brien's Own Gourmet Granola, Center Point, IA.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0737-2021·2021-06-30
Banner Smoked Fish Inc. Cold Smoked Tuna Recalled for Listeria Risk
Banner Smoked Fish Inc. brand Cold Smoked Tuna is being recalled because it may be contaminated with Listeria monocytogenes. All lots and package sizes are affected.
Product
Banner Smoked Fish Inc. brand Cold Smoked Tuna; Ingredients: Tuna, Salt, Sugar, Natural Wood Smoke
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-1924-2021·2021-06-30
Ultrasonic Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1905-2021·2021-06-30
SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Product
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1906-2021·2021-06-30
SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000
Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.
Product
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1916-2021·2021-06-30
Transducer Cover Lacks FDA 510(k) Clearance for Surgical Use
Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1912-2021·2021-06-30
Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.
Product
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1941-2021·2021-06-30
OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.
Product
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2021·2021-06-30
Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use
Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.
Product
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-0700-2021·2021-06-30
Favorite Day Monster Trail Mix Recalled for Plastic Contamination
John B. Sanfilippo & Son Inc. is recalling Favorite Day Monster Trail Mix (14 oz, Product Number 04313) because the product may contain stringy pieces of flexible plastic. The recall affects approximately 12,017 cases distributed nationwide.
Product
favorite day monster Trail Mix, Product Number 04313. Peanuts, M&M'S Milk Chocolate candies, raisins, milk chocolate chips and Peanut Butter Chips. Net Wt 14 oz. (396g), UPC 85239-15675
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0716-2021·2021-06-30
Raskin's Smoked Fish Recalled for Listeria Contamination Risk
Banner Smoked Fish Inc. is recalling all lots of Raskin's brand Pepper Crusted Sliced Nova smoked salmon because the product may be contaminated with Listeria monocytogenes.
Product
Raskin s brand Smoked Fish Pepper Crusted Sliced Nova (Farm raised Atlantic Salmon, black pepper, salt, sugar, sodium nitrite, natural hardwood smokead
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-1949-2021·2021-06-30
FDA Recalls Medical Action Minor Procedure Trays for Flaking Metal on Hemostats
Medical Action Industries is recalling 31 cases of Minor Procedure Trays because hemostats in the kits may have flaking metal or brown spots that could compromise sterile surgical procedures.
Product
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2021·2021-06-30
Econocare Plus Waffle Overlay Recalled for Bodily Fluid Contamination
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.
Product
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2021·2021-06-30
OneTouch Ultra Blue test strips recalled for temperature exposure damage
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.
Product
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0681-2021·2021-06-30
O'Brien's Own Gourmet Granola Chocolate Peanut Butter Recalled
O'Brien's Own Gourmet Granola in chocolate peanut butter flavor is being recalled because the product contains whey but does not declare milk on the label, posing a risk to consumers with milk allergies.
Product
O'Brien's Own Gourmet Granola, chocolate peanut butter, Net Wt. 12 OZ , UPC 6 09132 49668 4; Manufactured and Distributed by O'Brien's Own Gourmet Granola, Center Point, IA.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1902-2021·2021-06-30
Ventec VOCSN Ventilators May Shut Down Due to Component Failure
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
Product
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2021·2021-06-30
Medical Action Curved Hemostats recalled due to flaking metal risk
Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.
Product
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1923-2021·2021-06-30
Ultrasound probe covers recalled for missing required FDA 510k clearance
Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Product
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-0687-2021·2021-06-30
Clio Coconut Greek Yogurt Bars recalled for possible metal fragments
Clio LLC is recalling Clio Coconut Greek Yogurt Bars in 50g x 10-pack format due to the possible presence of metal fragments. The product was distributed nationwide.
Product
Clio Coconut Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC: 854021008046
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0683-2021·2021-06-30
Clio Berry Acai Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Berry Acai flavored Less Sugar Yogurt Bars in Chocolate Coating due to the possible presence of metal fragments. Affected products have best buy dates between April 11, 2021 and June 27, 2021.
Product
Clio Berry Acai flavored Less Sugar Yogurt Bar in a Chocolate Coating 45g x 10 Clio Retail 10-pack, UPC: 854021008244
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0689-2021·2021-06-30
Clio Expresso Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Expresso Greek Yogurt Bars due to the possible presence of metal fragments. The recall affects 6,733 cases distributed nationwide with best-by dates between February 14, 2021 and July 11, 2021.
Product
Clio Expresso Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 867155000244
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2021·2021-06-30
OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Product
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1930-2021·2021-06-30
FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V492000·2021-06-30
2021 Volkswagen Jetta Air Bag Control Module Welding Defect Recall
Volkswagen is recalling 2020-2021 Jetta vehicles because the air bag control module was welded in an incorrect position. This can cause air bags to deploy improperly during a crash or deploy unexpectedly, increasing injury risk.
Product
VOLKSWAGEN — VOLKSWAGEN JETTA
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0684-2021·2021-06-30
Clio Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Greek Yogurt Bars (50g x 10 retail packs) distributed nationwide due to the possibility of metal fragments in the product.
Product
Clio Greek Yogurt Bar wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC: 867155000206
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1947-2021·2021-06-30
novaplus General Purpose Kit hemostats recalled for potential metal flaking
Medical Action Industries is recalling novaplus General Purpose Kit (Cat. No. 56603) containing hemostats that may have flaking metal and brown spots on the instruments.
Product
novaplus, General Purpose Kit, Cat. No. 56603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0699-2021·2021-06-30
Good & Gather Sweet Cajun Trail Mix Recalled for Plastic Pieces
John B. Sanfilippo & Son Inc. is recalling Good & Gather Sweet Cajun Trail Mix because some packages may contain stringy pieces of flexible plastic.
Product
Good & Gather Sweet Cajun Trail Mix, Product Number 04659. with Butter Toffee Peanuts, Spicy Seasoned Peanuts, Cajun Sesame Sticks, Roasted Salted Corn Kernels & Honey Roasted Sesame Sticks. Net Wt 11 oz. (311g), UPC 85239-15700
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1937-2021·2021-06-30
OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
Product
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0696-2021·2021-06-30
Clio Strawberry Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Strawberry Greek Yogurt Bars due to the possible presence of metal fragments. The affected product was distributed nationwide.
Product
Clio Strawberry Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 861703000113
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1921-2021·2021-06-30
Ultrasonic Transducer Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1934-2021·2021-06-30
Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Product
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1925-2021·2021-06-30
Medical Device Recall: reSET App Grants Rewards Despite Positive Drug Screens
The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.
Product
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Category
Medical Device
Distribution
16 states
HighFDA (Food)·F-0751-2021·2021-06-30
Concord Farms Fresh Enoki Mushrooms Recalled for Listeria Contamination
Concord Farms Fresh Enoki Mushrooms have been recalled because samples tested positive for Listeria monocytogenes. The affected product was distributed to California, Nevada, and Minnesota.
Product
Concord Farms Fresh Enoki Mushrooms; 5.25 oz. (150g) or 7 oz. (200g) packages UPC: 049995041049 and 04999504103 US Distributor: Concord Farms, Vernon, CA All Natural, Product of Korea Keep Refrigerated. Rinse and Cook before eating.
Category
Food
Distribution
3 states
HighFDA (Food)·F-0682-2021·2021-06-30
Su Cocina Pan Molido Bread Crumbs Recalled for Undeclared Milk
Dominguez Foods of Washington is recalling Su Cocina Pan Molido bread crumbs because the label declares whey but does not declare milk, posing a risk to consumers with milk allergies.
Product
Su Cocina Pan Molido bread crumbs in 8 oz. packages. UPC 6 79790 05912 5. The label of 8 oz. package is read in parts: "***Plain Bread Crumbs *** Su Cocina Pan Molido***INGREDIENTS: Enriched wheat Flour ***Corn Starch, Corn Syrup, Water, Contains 2% or less of the following: So
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1908-2021·2021-06-30
Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance
Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.
Product
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Category
Medical Device
Distribution
6 states

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