The Recall Desk

Archive

September 2020 recalls

631 recalls were announced in September 2020.

What the numbers show

Critical
56
Severe
123
High
285
Moderate
154
Low
13

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

Which agencies issued them

401–500 of 631

  • ModerateFDA (Food)·F-1460-2020·2020-09-09

    Sundial Sea Moss Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sea Moss/Irish Moss products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERB***SEA MOSS/IRISH MOSS***2oz.***USES: IODINE, BREAKS UP FAT & MUCOUS, ADD, ULCERS, CALCIUM, THYROID, DETOX***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1489-2020·2020-09-09

    Sundial Herbal Products Recalls Koromantee Colonic Cleaner as Unapproved Drug

    Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles
    Category
    Drug
    Distribution
    1 state
  • 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-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 (Drugs)·D-1557-2020·2020-09-09

    Santa Cruz Recalls Subpotent UltraCruz Hand Sanitizing Gel

    Santa Cruz Biotechnology is recalling 14,238 bottles of UltraCruz Hand Sanitizing Gel because the product is subpotent.

    Product
    UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2930-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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 cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1440-2020·2020-09-09

    FDA Recalls Sundial Ethiopian Tenadam Herb for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Ethiopian Tenadam Herb because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1474-2020·2020-09-09

    Sundial Herbal Products Recalls Piss A Bed for Unapproved Drug Claims

    Sundial Herbal Products is recalling Piss A Bed herbal products under a permanent injunction because the products are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PISS A BED***1 oz.***USES: LIVER TONIC, ARTHRITIS, RHEUMATISM, KIDNEY, BLADDER, JAUNDICE***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1475-2020·2020-09-09

    Sundial White Pond Lily Herbal Product Recalled for Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE POND LILY***1oz.***USES: CANCER, DOUCHE, TUBERCULOSIS IN LYMPH GLANDS, GONORRHEA, ULCER IN MOUTH & THROAT***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1446-2020·2020-09-09

    Sundial Herbal Products Recalls Jamaican Bissy Powder for Unapproved Drug Claims

    Sundial Herbal Products is recalling Jamaican Bissy Powder because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    Jamaican Bissy Powder; "***Bissy regulates the heart, removes and prevents water from settling around the heart, lessens the desire for drugs, cigarettes, alcohol by clearing the body and blood of poison viruses & toxins etc. Relieves fatigue gives stamina and endurance enabling
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1462-2020·2020-09-09

    Sundial Black Sage Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Black Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1454-2020·2020-09-09

    Sundial Bitter Wood Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Wood herbal products under a court order because the labels make unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BITTER WOOD***2 oz.***USES: EXPELS WORMS IN THE WEST INTESTINES, DESTROYS PARASITES, LEUKEMIA, DESTROY APPETITE FOR ALCOHOL***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1473-2020·2020-09-09

    Sundial Pimento Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Pimento herbal products under a permanent injunction. The items are misbranded and deemed unapproved drugs due to specific labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1481-2020·2020-09-09

    Sundial Herbal Products Recalls Guinea Hen Weed for Unapproved Drug Claims

    Sundial Herbal Products is recalling Guinea Hen Weed herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***GUINEA HEN WEED***1 oz.***USES: ARTHRITIS, RHEUMATISM, STIMULATE IMMUNE SYSTEM, FIGHTS CANCER CELLS, VIRUSES, YEAST***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2914-2020·2020-09-09

    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 could cause holes and tears at the cuffs.

    Product
    PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1448-2020·2020-09-09

    Sundial Herbal Products Recalls Mitmitta Cayenne Pepper Product

    Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Mitmitta (Cayenne Pepper); "Traditional Uses: Prevents heart attacks, and lowers high blood pressure, stops internal bleeding, Heals ulcers and pains there of: Improves circulation, thins blood and keeps it moving***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1486-2020·2020-09-09

    Sundial Broom Weed Herbal Product Recalled for Misbranding and Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BROOM WEED***1oz.***USES: BREAKS UP INFECTION IN BLADDER & REPRODUCTIVE SYTSEM, VENEREAL DISEASE, FEVER***"; 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-1477-2020·2020-09-09

    Sundial Quassia Wood Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Quassia Wood under a court order because the product is misbranded and considered an unapproved drug due to its labeling.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***QUASSIA WOOD***2 oz.***USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES***"; packaged in clear plastic zip-top bags
    Category
    Food
    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 (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 elect
    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 im
    Category
    Drug
    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-1470-2020·2020-09-09

    Sundial Spanish Needle Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SPANISH NEEDLE***1oz.***USES: HEART AILMENTS, DIABETES, LOWERS FEVER***"; packaged in clear plastic zip-top bags
    Category
    Drug
    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-1500-2020·2020-09-09

    Sundial Cassava Meal Recalled as Unapproved Drug

    Sundial Herbal Products is recalling Sundial Cassava Meal because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1495-2020·2020-09-09

    Sundial Traditional Herbal Formula Heart Recalled for Misbranding

    Sundial Herbal Products is recalling its Traditional Herbal Formula Heart product because it is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***HEART***" packaged in boxes
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1447-2020·2020-09-09

    Sundial Herbal Products Recalls Ghanian Black Spice for Unapproved Drug Claims

    Sundial Herbal Products is recalling Ghanian Black Spice because the product is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Ghanian Black Spice; "***USES:***DYSENTERY, DIARRHEA, RHEUMATISM, FACILITATES CHILDBIRTH***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1466-2020·2020-09-09

    Sundial Herbal Products Recalls Mojo Bush Under FDA Injunction

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MOJO BUSH***1 oz.***USES: SKIN, BLOOD PURIFIER, STOMACH & INTESTINAL CLEANSER, REMOVES PARASITES***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1484-2020·2020-09-09

    Sundial King of the Forest Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling King of the Forest herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***KING OF THE FOREST***1 oz.***USES: HYPERTENSION, ASTHMA, THROAT, KIDNEY, LIVER SPOTS, HERPES RASHES***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1483-2020·2020-09-09

    Sundial Herbal Products Recalls Jack in the Bush Due to Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***JACK IN THE BUSH***1oz.***USES: COLD MEDICINE (ESP. IN CHILDREN), CALMS THE NERVES, RELIEVES DEPRESSION***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • 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 (Food)·F-1453-2020·2020-09-09

    Sundial Mango Bark Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO BARK***2 oz.***USES: KIDNEY STONE, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1499-2020·2020-09-09

    Sundial Herbal Products Recalls Axum Ethiopian Honey Beverage

    Sundial Herbal Products is recalling Axum Ethiopian Honey Beverage because it is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "AXUM ETHOIPIAN HONEY BEVERAGE***SUNDIAL HERBS***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1488-2020·2020-09-09

    Sundial Wood and Root Tonic Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Wood and Root Tonic under a permanent injunction because the product is misbranded and deemed an unapproved drug.

    Product
    "Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the body and the blood of mucus, and toxic waste.***used by the Carib Indians of Central America to Protect them against epid
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1469-2020·2020-09-09

    Sundial Herbal Products Recalls Jamaican Milk Wiss Due to Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***JAMAICAN MILK WISS***2oz.***USES: REMOVES MUCOUS FROM THE BODY, TUMORS***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1451-2020·2020-09-09

    Sundial Herbal Products Recalls Cerasee Herbal Product for Misbranding

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

    Product
    "SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1441-2020·2020-09-09

    Sundial Princess Almaz Spiced Tea Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Princess Almaz Spiced Tea because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    SUNDIAL PRINCESS ALMAZ Traditional ETHIOPIAN Organic SPICED TEA; "***Improves circulation***eliminates gas stomach griping & cramps. Relieves acid reflux, coughs, flu, hay fever, allergies, breaks up mucus and fights infection***" packaged in a breathable-type bag within a box.
    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-2872-2020·2020-09-09

    GE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues

    GE Healthcare is recalling 221 OEC 9800 and 9900 C-Arms because field service engineers changed the dose display to DAP, violating FDA regulations requiring AKR/CAK.

    Product
    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, crit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2933-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-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 electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1496-2020·2020-09-09

    Sundial Herbal Worms and Parasites Formula Recalled as Unapproved Drug

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Worms & Parasites because the product is misbranded and deemed an unapproved drug.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1561-2020·2020-09-09

    Leiper's Fork Distillery Recalls Alcohol Antiseptic Topical Solution Due to Methanol Labeling

    Leiper's Fork Distillery is recalling 1,996 gallons of 70% Ethyl Alcohol Antiseptic Topical Solution because the product is labeled to contain methanol.

    Product
    Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
    Category
    Drug
    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-1479-2020·2020-09-09

    Sundial White Jointa Herbal Product Recalled for Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1442-2020·2020-09-09

    Sundial Moringa Leaf Powder Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Nigerian Moringa Leaf Powder because the product is misbranded and deemed an unapproved drug due to specific labeling claims.

    Product
    SUNDIAL NIGERIAN MORINGA LEAF POWDER; "***Anti-inflammatory, builds Red Blood cells***" 4oz and 8oz jars
    Category
    Food
    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 (Food)·F-1456-2020·2020-09-09

    Sundial Mango Leaf Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Food
    Distribution
    1 state
  • 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-1560-2020·2020-09-09

    Bersih Hand Sanitizer Gel Recalled for cGMP Deviations

    Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel due to cGMP deviations. The product was distributed in the United States.

    Product
    Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
    Category
    Drug
    Distribution
    0 states
  • 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 (Devices)·Z-2932-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,197 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V545000·2020-09-08

    Autocar Recalls 2019 Xpeditor Vehicles for Methane Detection Wiring Fire Risk

    Autocar is recalling 170 2019 Xpeditor vehicles equipped with factory-installed methane detection systems because inadequate circuit protection may cause the wiring harness to overheat, increasing the risk of a fire.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V544000·2020-09-08

    2021 Coachmen Catalina Recalled Due to Griddle Fire Risk

    Forest River is recalling 2021 Coachmen Catalina trailers because a long griddle hose allows open flames to be stowed inside, increasing fire risk.

    Product
    COACHMEN — COACHMEN CATALINA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09042020-01·2020-09-04

    USDA Issues Public Health Alert for Ineligible Imported Cooked Duck Blood Curds

    USDA FSIS issued a public health alert for imported cooked duck blood curds from China that lack required inspection certificates, making them unfit for human consumption.

    Product
    FSIS Issues Public Health Alert for Ineligible Imported Cooked Duck Blood Curds from China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V540000·2020-09-04

    2021 Forest River Berkshire Motorhomes Recalled for Inverter Overload Fire Risk

    Forest River is recalling 2021 Berkshire motorhomes with 3000W inverters that overload electrical wiring and create a fire risk. Owners should contact Forest River at 1-754-533-5934 for a free replacement inverter.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V543000·2020-09-04

    Hyundai Tucson 2016-2021: Engine Compartment Fire from Brake Control Unit

    Hyundai is recalling 2016-2021 Tucson vehicles because the Anti-lock Brake Hydraulic Electronic Control Unit could corrode and cause an electrical short, creating a risk of engine compartment fire.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20776·2020-09-03

    CFMOTO Recalls 2020 ZFORCE 950 Sport Vehicles Due to Fire Hazard

    CFMOTO is recalling 2020 ZFORCE 950 Sport vehicles because a fuel line fitting may fail to lock, causing fuel leaks and fire.

    Product
    2020 ZFORCE 950 Sport Recreational Off-Highway Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20775·2020-09-03

    SODA SENSE Recalls CO2 Canisters Due To Valve Ejection Injury Hazard

    SODA SENSE is recalling about 19,200 CO2 canisters because a valve can break and eject, posing an injury hazard. No injuries have been reported, but minor property damage has occurred.

    Product
    SODA SENSE® CO2 canisters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V537000·2020-09-03

    2021 Chevrolet Trailblazer and 2020 Buick Encore GX Seat Fastener Recall

    General Motors is recalling 2021 Chevrolet Trailblazers and 2020 Buick Encore GX vehicles because front seat rear attachment bolts may not have been installed, potentially allowing seats to move during a crash.

    Product
    BUICK — BUICK, CHEVROLET ENCORE, TRAILBLAZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V539000·2020-09-03

    Western Star and Freightliner trucks recalled for suspension hardware defect

    Daimler Trucks recalls 2020-2021 Western Star 4700 and 4900, and Freightliner 114SD and 122SD trucks due to suspension axle hardware that may be insufficiently long to engage locking nuts, creating road hazards and crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 122SD, 4900, 114SD, 4700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20774·2020-09-03

    StoreYourBoard Recalls Hi-Lift Storage Hoists Due to Strap Breakage Hazard

    StoreYourBoard.com is recalling Hi-Lift Storage Hoists because green polypropylene straps can break, causing stored items to fall and potentially injure passersby.

    Product
    Hi-Lift Storage Hoist Classic and Pro models sold with green polypropylene straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V538000·2020-09-03

    2021 Keystone Fuzion and Impact Trailers Fuel Tank Mounting Bolts Recall

    Keystone is recalling certain 2021 Fuzion and Impact recreational trailers with improperly secured auxiliary fuel supply tank mounting bolts. The defective grade 2 bolts may break, causing the tank to detach and increasing risk of fire or vehicle crash.

    Product
    KEYSTONE — KEYSTONE FUZION, IMPACT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1551-2020·2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL due to cross-contamination with undeclared benzyl alcohol.

    Product
    Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1275-2020·2020-09-02

    Thomson International Recalls Sweet Yellow Onions Linked to Salmonella Outbreak

    Thomson International is recalling Sweet Yellow onions after a traceback investigation linked red onions to a Salmonella Newport outbreak.

    Product
    Sweet Yellow onions; Packed under brand names of Thomson Premium, TLC Thomson International. Thomson Premium: 50 lb. mesh sack -No UPC TLC Thomson International; 40 lb. Carton - No UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1534-2020·2020-09-02

    Medichem Recalls Chlorhexidine Gluconate Due to Serratia marcescens Contamination

    Medichem S.A. is recalling Chlorhexidine Gluconate 0012 for manufacturing due to microbial contamination with Serratia marcescens.

    Product
    Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1552-2020·2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers due to cross-contamination with undeclared benzyl alcohol.

    Product
    Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1553-2020·2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 10,000 units injection containers due to cross contamination with undeclared benzyl alcohol and missing parabens.

    Product
    Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1269-2020·2020-09-02

    Emerald Fruit & Produce Recalls Unlabeled White Onions Due to Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 55 lbs of unlabeled white onions in Oregon due to potential Salmonella Newport contamination.

    Product
    Onions White Whole Dry 5 lb bag (item 78158) for foodservice use, shelf life 14 days, packed in 5 lbs. cello bag and stored in box - No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1267-2020·2020-09-02

    Emerald Fruit & Produce Recalls Sliced Onions Due to Salmonella Risk

    Emerald Fruit & Produce Inc is recalling sliced white onions sold for foodservice use in Oregon due to potential Salmonella Newport contamination.

    Product
    M60064CS Onions White Sliced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1274-2020·2020-09-02

    Thomson International Recalls White Onions Linked to Salmonella Outbreak

    Thomson International is recalling white onions packed under Thomson Premium, Onions 52, and El Competitor brands due to a link to a Salmonella Newport outbreak.

    Product
    White onions; Packed under brand names of Thomson Premium, Onions 52, El competitor. Thomson Premium: 25 lb. mesh sack -No UPC 50 lb. mesh sack -No UPC Onions 52: 8 lb. mesh bag - UPC 8 15222 01019 1 El Competitor 50 lb. mesh sack - No UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1255-2020·2020-09-02

    Progressive Produce Recalls Red Onions Due to FDA Class I Hazard

    Progressive Produce LLC is recalling red onions supplied by Thomson Onions. The FDA classified this recall as Class I, indicating a serious health risk.

    Product
    Red Onions; Pacific Gold 25 Lb. RED Onion JBO - Pacific Gold w/plu 50 lb. SX Red Onion JBO US #1 Sold to consumers in bulk pins. in bulk bins
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1271-2020·2020-09-02

    Emerald Fruit & Produce Recalls Processed Onions for Salmonella Risk

    Emerald Fruit & Produce is recalling processed onions due to potential Salmonella Newport contamination. The product was distributed in Oregon.

    Product
    Onions Red Rings 3/16 (item 78267) sold by 5 lb bag for foodservice use, perishable, refrigerated, shelf life 5 days, packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1272-2020·2020-09-02

    Red Onions Recalled Due to Salmonella Newport Outbreak Investigation

    Thomson International is recalling red onions nationwide and in Canada because a traceback investigation linked them to a Salmonella Newport outbreak.

    Product
    Red onions; Packed under brand names of Thomson Premium, Onions 52, Utah Onions, Harley's Best, Onions 52, Imperial Fresh, TLC Thomson International, El Competidor Thomson Premium packed in 50 and 25 lb.mesh sack, and 2 lb. mesh sack - UPC 33383 60101 3 lb. mesh sack - UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1273-2020·2020-09-02

    Thomson International Recalls Yellow Onions Linked to Salmonella Outbreak

    Thomson International is recalling yellow onions nationwide and in Canada after a traceback investigation linked red onions to a Salmonella Newport outbreak.

    Product
    Yellow onions; Packed under brand names of Onions 52, Majestic, Hartley's Best, Kroger, Food Lion, Thomson Premium, TLC Thomson International, El competitor, Tender Loving Care, Imperial Fresh. Onions 52: 10 lb. mesh sack - UPC 33383 60004 3 lb. mesh sack - UPC 33383 60002
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1537-2020·2020-09-02

    Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination

    Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.

    Product
    Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2020·2020-09-02

    Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations

    Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2869-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1544-2020·2020-09-02

    Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations

    Bayshore Pharmaceuticals is voluntarily recalling 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2858-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1550-2020·2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.

    Product
    Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1260-2020·2020-09-02

    Emerald Fruit & Produce Recalls Sliced Onions for Salmonella Risk

    Emerald Fruit & Produce is recalling sliced yellow onions for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60026CS Onions Yellow Sliced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1263-2020·2020-09-02

    Emerald Fruit & Produce Recalls Sliced Red Onions Due to Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 195 lbs of sliced red onions sold in Oregon due to potential Salmonella Newport contamination.

    Product
    M60023CS Onions Red Sliced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·20V531000·2020-09-02

    Gulf Stream Enlighten Travel Trailer Recall for Refrigerator Seal Defect

    Gulf Stream is recalling 2020 Enlighten travel trailers because a missing refrigerator trim strip may allow carbon monoxide or flammable gas to enter the living area.

    Product
    GULF STREAM — GULF STREAM ENLIGHTEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2020·2020-09-02

    Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire

    Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2854-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2880-2020·2020-09-02

    Biosense Webster Recalls CARTO 3 System Software Due to Defect

    Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.

    Product
    CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1270-2020·2020-09-02

    Emerald Fruit & Produce Recalls Unlabeled Yellow Onions for Salmonella Risk

    Emerald Fruit & Produce Inc. is recalling 55 lbs. of unlabeled yellow onions due to potential Salmonella Newport contamination. The product was distributed in Oregon.

    Product
    Onions Yellow Whole Dry 5 lb. bag (item 78155) for foodservice use. Shelf life 14 days, packed in 5 lbs. cello bag and stored in box - No label was attached/provided.
    Category
    Food
    Distribution
    1 state

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