The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
210
High
285
Moderate
100
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 33% are Severe.

501–600 of 633

  • SevereUSDA FSIS·076-2018·2018-09-05

    Wayne Farms Recalls Frozen Chicken Products Due to Metal Contamination

    Wayne Farms is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may contain metal pieces. Consumers are advised not to consume these items.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Fully Cooked Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1906-2018·2018-09-05

    Coca-Cola Recalls Minute Maid Tropical Blend Juice Due to Glass

    The Coca-Cola Company is recalling 432 bottles of Minute Maid Tropical Blend juice because foreign matter believed to be glass was found in retained samples.

    Product
    Consumer Packaging (PET bottle): Minute Maid TROPICAL BLEND Flavored Juice Beverage 12 FL OZ (355mL), JAN0719NPA, UPC: 0 25000 06229 2. Master Case: packaged 24/12 fl.oz., GTIN number 00025000062414 (no UPC)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1130-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2018·2018-09-05

    Auro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.

    Product
    Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1165-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Enanthate/Cypionate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.

    Product
    Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1852-2018·2018-09-05

    Marsee Foods Recalls Cafe YUMM! Chocolate Chip Cookies for Undeclared Peanuts

    Marsee Foods Inc is recalling Cafe YUMM! Chocolate Chip Cookies because they may contain undeclared peanuts. The cookies were sold at Cafe Yumm! restaurants in Oregon and Washington.

    Product
    Chocolate Chip Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and each box contains 24 cookies. The master case is taped shut and labeled with the contents and production date, along with a lot code. The…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1161-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 90 vials of Methyl-Cobalamin injectable because inadequate processes and equipment were used to assure sterility.

    Product
    Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 2,085 vials of Human Chorionic Gonadotropin 4000 IU nationwide due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2018·2018-09-05

    Auro Pharmacies Recalls Dexpanthenol Injectable Vials Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment to assure sterility.

    Product
    Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1137-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

    AvKARE is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1134-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 80mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2878-2018·2018-09-05

    Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices

    Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.

    Product
    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1145-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V588000·2018-09-05

    Navistar Recalls International Trucks Due to Fuel Line Burst Risk

    Navistar is recalling specific International trucks because a restricted fuel pump screen may cause the fuel line to burst, leading to fuel leaks or engine stalling.

    Product
    INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, PAYSTAR, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 74 vials of Methyl-Cobalamin injectable because the manufacturer could not assure the sterility of the product.

    Product
    Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·075-2018·2018-09-05

    Caito Foods Recalls Chicken Salad for Undeclared Walnut Allergen

    Caito Foods is recalling 242 pounds of chicken salad containing undeclared walnuts. The products were distributed to retail locations in four states.

    Product
    Caito Foods, LLC — Caito Foods, LLC Recalls Chicken Salad Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1154-2018·2018-09-05

    Pharmcore Recalls Methylcobalamin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 1,115 vials of Methylcobalamin 10 mg due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1139-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling 599 vials of Ipamorelin 9 mg because the company cannot assure the sterility of the product.

    Product
    Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 320mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2018·2018-09-05

    RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.

    Product
    Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1164-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.

    Product
    Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1132-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1903-2018·2018-09-05

    Ararat Eggplant Paste Recalled Due to High pH Levels

    Artashes LLC is recalling Ararat Eggplant Paste because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Eggplant Paste 18.3 oz. glass jar; Ingredients: Eggplants, Red pepper (fresh and grinded), tomato paste, vegetable oil, onion, garlic, carrot, green salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1153-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling Ipamorelin 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1914-2018·2018-09-05

    Howard Calcagno Farms Recalls Cilantro Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling cilantro shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Cilantro was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1135-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 160mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1160-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable because inadequate processes and equipment failed to assure product sterility.

    Product
    Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V579000·2018-09-05

    Toyota Recalls 2016-2018 Prius Vehicles for Electrical Fire Risk

    Toyota is recalling 2016-2018 Prius vehicles because a worn engine wire harness could cause an electrical short and increase the risk of a fire.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2018·2018-09-05

    Auro Pharmacies Recalls Folic Acid Injectable Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 40 vials of Folic Acid injectable due to inadequate processes and equipment to assure sterility.

    Product
    Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 3,351 vials of Human Chorionic Gonadotropin 6000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1144-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets

    Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2941-2018·2018-09-05

    MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E088000·2018-09-05

    AXN Heavy Duty Recalls Trailer Axles Due to Wheel Separation Risk

    AXN Heavy Duty LLC is recalling certain trailer axles because the wheel end nut locking device may not be properly installed, allowing the wheel end to separate from the axle.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2018·2018-09-05

    Auro Pharmacies Recalls Glutathione Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.

    Product
    Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1905-2018·2018-09-05

    Ararat Cut Beets Recalled Due to High pH Levels

    Artashes LLC is recalling Ararat Cut Beets because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Cut Beets; 19 oz. glass jar; Ingredients: Cut Beets, Water, Salt, Sugar, Citric Acid. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1141-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1913-2018·2018-09-05

    Howard Calcagno Farms Recalls Spinach Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling spinach shipped in cardboard boxes labeled with the firm's name in Aurora, Oregon, due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Spinach was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2937-2018·2018-09-05

    MedComp Duo-Flow XTP Straight Full Set Recalled for Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow XTP Straight Full Sets because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1921-2018·2018-09-05

    Howard Calcagno Farms Recalls Italian Parsley Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling 5 dozen of Italian parsley shipped in Oregon due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Italian Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1916-2018·2018-09-05

    Howard Calcagno Farms Recalls Red Leaf Lettuce Due to Cyclospora Risk

    Howard Calcagno Farms is recalling Red Leaf Lettuce shipped in Oregon due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2947-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1917-2018·2018-09-05

    Howard Calcagno Farms Recalls Romaine Lettuce Due to Cyclospora Risk

    Howard Calcagno Farms is recalling romaine lettuce shipped in boxes labeled with the firm name in Aurora, Oregon, due to potential Cyclospora cayetanensis contamination.

    Product
    Romaine Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1927-2018·2018-09-05

    Howard Calcagno Farms Recalls Dill for Potential Cyclospora Contamination

    Howard Calcagno Farms is recalling dill due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Dill was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2958-2018·2018-09-05

    FDA Recalls Li-ion Battery Packs for BIS Monitoring Systems

    The FDA is recalling Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems due to a Class II safety issue.

    Product
    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1923-2018·2018-09-05

    Howard Calcagno Farms Recalls Red Chard Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling Red Chard shipped in boxes labeled with the firm's name in Aurora, Oregon, due to potential contamination with Cyclospora cayetanensis.

    Product
    Red Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1925-2018·2018-09-05

    Howard Calcagno Farms Recalls Bright Light Chard Due to Cyclospora Risk

    Howard Calcagno Farms is recalling Bright Light Chard due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Bright Light Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2955-2018·2018-09-05

    GE Carestation 30 Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 252 Carestation 30 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 30 anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2954-2018·2018-09-05

    GE Carestation Anesthesia Systems Recalled for Gas Switch Defect

    GE Medical Systems is recalling 310 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·077-2018·2018-09-05

    New York Style Sausage Co. Recalls Raw Chorizo for Undeclared Sesame

    New York Style Sausage Co. is recalling raw chorizo sausage because it contains undeclared sesame seed. No adverse reactions have been reported.

    Product
    NEW YORK STYLE SAUSAGE CO. — New York Style Sausage Co. Recalls Raw Chorizo Sausage Products due to Misbranding and an Undeclared Ingredient
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1911-2018·2018-09-05

    Howard Calcagno Farms Recalls Collards Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling collards shipped in cardboard boxes labeled with the firm's name in Aurora, Oregon, due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Collards were shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2940-2018·2018-09-05

    MedComp Recalls Soft-Line Duo-Flow Catheters Due to Suture Wing Cracking

    Medical Components, Inc. is recalling Soft-Line Duo-Flow catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, or air emboli.

    Product
    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2938-2018·2018-09-05

    MedComp Duo-Flow Double Lumen Catheters Recalled for Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow Double Lumen Catheters because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2018·2018-09-05

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2933-2018·2018-09-05

    MedComp Recalls Double Lumen CRRT Catheter Sets Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling specific hemodialysis catheter insertion kits because the suture wings may crack or break, posing a risk of patient injury.

    Product
    Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1855-2018·2018-09-05

    Morgan Foods Recalls Tomato Condensed Soup Due to Undeclared Allergens

    Morgan Foods is recalling 6,168 cans of Tomato Condensed Soup because the product contains cream of mushroom soup with undeclared milk and soy.

    Product
    Tomato Condensed Soup, 26 oz (1 LB 10 OZ) 737 g, 307 x 512 Can, Family Size, 12 cans per tray, shelf stable
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1924-2018·2018-09-05

    Howard Calcagno Farms Recalls Green Chard Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling green chard from Oregon due to a potential contamination with Cyclospora cayetanensis.

    Product
    Green Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18765·2018-09-05

    Polaris Recalls 2018 Ranger Recreational Off-Highway Vehicles Due to Crash Hazard

    Polaris is recalling about 1,000 model year 2018 Ranger 500, 570, EV, and EV LI-ION vehicles because front lower control arms can separate, posing a crash hazard.

    Product
    Model year 2018 Polaris Ranger 500, Ranger 570, Ranger EV, and Ranger EV LI-ION recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1915-2018·2018-09-05

    Howard Calcagno Farms Recalls Green Leaf Lettuce Due to Cyclospora Risk

    Howard Calcagno Farms is recalling Green Leaf Lettuce shipped in Oregon due to potential contamination with Cyclospora cayetanensis.

    Product
    Green Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1857-2018·2018-09-05

    Tipu's Chai Sweetened Masala Chai Recalled for Undeclared Milk

    Tipu's Chai is recalling Sweetened Masala Chai boxes because the packaging fails to declare milk, which is present in the single-serve sachets inside.

    Product
    Tipu's Chai - Sweetened Masala Chai, Net wt.7.5 oz. per box. UPC #: 7 19196 20035 3. Each box contains five single serve sachet packets of Chai Tea Latte. Single serve sachet Chai Tea Latte packets, net wt. 1.1 oz per packet. UPC 7 19196 20073 5. The LABEL of Sweetened…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1901-2018·2018-09-05

    Hostess Brownies Cookies 'n Crème Recalled for Missing Egg Allergen Labeling

    Hostess Brands is recalling specific lots of Brownies Cookies 'n Crème because the packaging fails to declare egg in the 'Contains' statement, despite egg being an ingredient.

    Product
    Hostess Brownies Cookies 'n Cr¿me packaged in the following ways: 1) 6 Brownies individually wrapped packaged in a cardboard box Net Wt. 8.68 OZ (246 g) UPC 888109113575; 2) 2 Brownies packaged in a cardboard box Net Wt. 2.89 OZ (82 g) UPC 888109012021
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2930-2018·2018-09-05

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1128-2018·2018-09-05

    Baxter Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations

    Baxter Healthcare is recalling 33,600 bags of 0.9% Sodium Chloride Injection USP due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed only in Texas and Mississippi.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2950-2018·2018-09-05

    Haemonetics OrthoPAT System-Integrated Set Recalled Due to Missing Cannula

    Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.

    Product
    Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1922-2018·2018-09-05

    Howard Calcagno Farms Recalls Beets for Potential Cyclospora Contamination

    Howard Calcagno Farms is recalling beets shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Beet was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2925-2018·2018-09-05

    Stryker Mako Vizadisc Hip Procedure Tracking Kit Recall for Detection Failure

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.

    Product
    Stryker Mako Vizadisc Hip Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1929-2018·2018-09-05

    Premo Turkey & Cheese Wedge Sandwiches Recalled for Listeria Risk

    Lipari Foods is recalling Premo Turkey & Cheese Wedge sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic triangle sandwich wedge container with plastic film. Refrigerated. 4, 5 OZ retail units per wholesale case.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2946-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2931-2018·2018-09-05

    CSL Behring Recalls N Latex CDT Kits Due to Measurement Bias

    CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.

    Product
    N Latex CDT Kit
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2927-2018·2018-09-05

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2932-2018·2018-09-05

    MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking Risk

    Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1918-2018·2018-09-05

    Howard Calcagno Farms Recalls Bok Choy Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling 30-pound boxes of Bok Choy distributed in Oregon due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Bok Choy was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1926-2018·2018-09-05

    Howard Calcagno Farms Recalls Lacinato Kale Due to Cyclospora Risk

    Howard Calcagno Farms is recalling Lacinato Kale due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Lacinato Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1928-2018·2018-09-05

    Howard Calcagno Farms Recalls Mint for Potential Cyclospora Contamination

    Howard Calcagno Farms is recalling 5 dozen mint due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Mint was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1920-2018·2018-09-05

    Howard Calcagno Farms Recalls Parsley Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling parsley shipped in cardboard boxes labeled with the firm name due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1908-2018·2018-09-05

    Ochoa's Queseria Recalls Mexican Style Ricotta Cheese for Undeclared Milk Allergen

    Ochoa's Queseria LLC is recalling Don Froylan Requeson Mexican Style Ricotta Cheese because the label fails to declare milk, a major food allergen.

    Product
    Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Cheese***Ingredients: Pasteurized Whey, Salt***" 1lb. (16 oz.) and bulk plastic bags in 2lb. and 5lb.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2939-2018·2018-09-05

    MedComp Recalls Soft-Line Duo-Flow Double Lumen Catheter Trays

    Medical Components, Inc dba MedComp is recalling Soft-Line Duo-Flow Double Lumen Catheter Trays because suture wings may crack or break, posing a risk of patient injury.

    Product
    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2936-2018·2018-09-05

    MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking

    Medical Components, Inc. is recalling hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1910-2018·2018-09-05

    Howard Calcagno Farms Recalls Kale Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling kale shipped in cardboard boxes due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.

    Product
    Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1912-2018·2018-09-05

    Howard Calcagno Farms Recalls Mustard Due to Cyclospora Contamination Risk

    Howard Calcagno Farms is recalling mustard shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Mustard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2934-2018·2018-09-05

    MedComp Recalls Duo-Flow Hemodialysis Catheter Sets Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2935-2018·2018-09-05

    MedComp Recalls Duo-Flow IJ Full Trays Due to Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2929-2018·2018-09-05

    Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2018·2018-09-05

    GE 9100c NXT anesthesia systems recalled for gas switch defect

    GE Medical Systems is recalling 401 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.

    Product
    GE 9100c NXT anesthesia systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2942-2018·2018-09-05

    MedComp Recalls Duo Flow Double Lumen Catheters Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1919-2018·2018-09-05

    Howard Calcagno Farms Recalls Napa Cabbage Due to Cyclospora Risk

    Howard Calcagno Farms is recalling Napa Cabbage distributed in Oregon due to a potential for contamination with Cyclospora cayetanensis.

    Product
    Napa Cabbage was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2910-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2957-2018·2018-09-05

    Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error

    Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.

    Product
    FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1904-2018·2018-09-05

    Ararat Grilled Eggplant and Peppers Recalled for pH Levels

    Artashes LLC is recalling Ararat Grilled Eggplant and Peppers because FDA inspection found pH levels above the scheduled process.

    Product
    Ararat Grilled Eggplant and Peppers 23 oz. glass jar; Ingredients: Eggplants, tomatoes, green pepper, salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2923-2018·2018-09-05

    Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results

    Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.

    Product
    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders.…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2903-2018·2018-09-05

    Stryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2908-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2948-2018·2018-09-05

    Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging

    Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.

    Product
    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2906-2018·2018-09-05

    Stryker QUIKFLAP Cranial Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1902-2018·2018-09-05

    Ararat Imambayeldy Recalled Due to pH Levels Above Scheduled Process

    Artashes LLC is recalling Ararat Imambayeldy because FDA inspections found pH levels above the scheduled process.

    Product
    Ararat Imambayeldy; 18.3 oz. glass jar; Ingredient: Eggplant, tomato paste, onions, vegetable oil, garlic, green salt Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
    Category
    Food
    Distribution
    1 state

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