The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
405
High
251
Moderate
213
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.

Which agencies issued them

301–400 of 944

  • HighFDA (Devices)·Z-0474-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2020·2019-11-27

    Altaire Recalls Equate Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Eye Allergy Relief Drops because the company cannot ensure the product is sterile.

    Product
    Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0248-2020·2019-11-27

    Del Monte Spicy Pomodoro Linguine Recalled for Listeria Risk

    Mann Packing Company is recalling Del Monte Better Break Spicy Pomodoro Linguine due to a Listeria monocytogenes alert. Consumers should check best-by dates and stop eating the product.

    Product
    Del Monte brand Better Break Spicy Pomodoro; Linguine with Tomato Chipotle Sauce. UPC 717524671004 7 oz. container 6 x 7 oz. per carton
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0423-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0160-2020·2019-11-27

    Mical Seafood Recalls Tuna Loin Due to Scombroid Food Poisoning Complaints

    Mical Seafood is recalling specific lots of tuna loin due to customer complaints of scombroid food poisoning. The recall covers products with production dates from April to May 2019.

    Product
    Tuna Loin 5-8 lb AAA CO 30lb case Tuna Loin 3-5 lb AAA CO 30lb case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0430-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and in the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0296-2020·2019-11-27

    Mann's Crave a Bowl Zesty Green Chili Recalled for Listeria

    Mann Packing Company is recalling Mann's Crave a Bowl Zesty Green Chili due to a positive test for Listeria monocytogenes.

    Product
    Mann's Crave a Bowl Zesty Green Chili 6 x 7 oz. UPC: 716519040061- Canada
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0495-2020·2019-11-27

    AMD Medicom Recalls Level 3 Masks Due to Packaging Error

    AMD Medicom is recalling Level 3 masks because Level 2 masks may have been packed in Level 3 boxes. The masks are visually indistinguishable, creating a risk of using lower protection.

    Product
    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0443-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects 16 units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2020·2019-11-27

    Conversio Health Recalls Albuterol, Ipratropium, and Budesonide Inhalation Vials

    Integrated Health Concepts Inc. dba Conversio Health is recalling Albuterol, Ipratropium, and Budesonide inhalation vials due to a lack of processing controls.

    Product
    Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Vials Due to Processing Controls

    Conversio Health is recalling Albuterol 2.5mg / Ipratropium 0.75mg vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2020·2019-11-27

    StellaLife VEGA Oral Gel Rinse Recalled for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling StellaLife VEGA Oral Gel Rinse because it was not manufactured under current good manufacturing practices.

    Product
    StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2020·2019-11-27

    Washington Homeopathic Products Recalls R2103 Due to Manufacturing Deviations

    Washington Homeopathic Products, Inc. is recalling R2103 homeopathic product because it was not manufactured under current good manufacturing practices.

    Product
    R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials

    Conversio Health is recalling Albuterol, Ipratropium, and Triamcinolone inhalation vials due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2020·2019-11-27

    Neocis Guidance System Fiducial Array Recalled for Measurement Mismatch

    Neocis Inc. is recalling three units of the Neocis Guidance System Fiducial Array because they may mismatch measurement files, resulting in a failed landmark check.

    Product
    Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2020·2019-11-27

    Angiodynamics Recalls Mislabelled Starburst Electrosurgical Devices

    Angiodynamics Inc. is recalling 30 Starburst Talon Semi-Flex Electrosurgical Devices that were incorrectly labelled as Starburst MRI Semi-Flex devices, potentially causing procedural delays.

    Product
    Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0492-2020·2019-11-27

    Washington Homeopathic Products Recalls Calcarea Phosphorica 6X Tablets

    Washington Homeopathic Products, Inc. is recalling 681 bottles of Calcarea Phosphorica 6X tablets because they were not manufactured under current good manufacturing practices.

    Product
    Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64189 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 135 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials

    Conversio Health is recalling Albuterol and Ipratropium inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2020·2019-11-27

    Washington Homeopathic Recalls Calcarea Fluorica 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 489 bottles of Calcarea Fluorica 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2020·2019-11-27

    Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates

    Cincinnati Sub-Zero is recalling 3,932 Blanketrol III Hyper-Hypothermia Systems to add warnings about tissue damage from extended high temperatures and clarify automatic mode usage.

    Product
    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2020·2019-11-27

    Washington Homeopathic Products Recalls Natrum Phosphoricum 6X Tablets

    Washington Homeopathic Products, Inc. is recalling Natrum Phosphoricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64192 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2020·2019-11-27

    Nucryo PolarCath Balloon Catheters Recalled for Incorrect Sterilization Labeling

    Nucryo Vascular Inc. is recalling 49 PolarCath Balloon Catheters because they were mislabeled as ethylene oxide sterilized instead of E-beam sterilized.

    Product
    The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-0172-2020·2019-11-27

    Basic Reset Recalls Vibrant Energy Drink for CGMP Violations

    Basic Reset Inc. is recalling 1,980 canisters of Vibrant Energy Drink because the products do not conform to Dietary Supplement CGMP regulations.

    Product
    Vibrant ENERGY DRINK 450 g plastic canister 100-4A
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0501-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Filled Non-Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0178-2020·2019-11-27

    Basic Reset Recalls SlimUp Dietary Supplement for CGMP Non-Compliance

    Basic Reset Inc. is recalling SlimUp dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    SlimUp 60 capsules per plastic bottle, SKU: 100-5B
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0176-2020·2019-11-27

    Basic Reset Recalls Mello-Tonin Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling Mello-Tonin dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Mello-Tonin 2 fl. oz. glass bottle, SKU: 100-5C
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0494-2020·2019-11-27

    Washington Homeopathic Recalls Cell Salts Combination 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Cell Salts Combination 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64200 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2020·2019-11-27

    Washington Homeopathic Products Recalls Kali Sulphuricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 295 bottles of Kali Sulphuricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64196 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0416-2020·2019-11-27

    Guardia Access Embryo Transfer Catheter Recall Due to Bent Tips

    The FDA is recalling the Guardia Access Embryo Transfer Catheter because bent tips can make insertion difficult, potentially requiring repeat procedures. No injuries have been reported, so the recall is classified as moderate severity.

    Product
    Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0412-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5051) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5051
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0505-2020·2019-11-27

    Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect

    Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.

    Product
    XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0177-2020·2019-11-27

    Basic Reset pH-FX Dietary Supplement Recalled for CGMP Non-Compliance

    Basic Reset Inc. is recalling pH-FX dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    pH-FX 4 fl. oz. plastic bottle, SKU: 100-1A
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0182-2020·2019-11-27

    Basic Reset Recalls Q-min Dietary Supplement for CGMP Non-Compliance

    Basic Reset Inc. is recalling Q-min dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Q-min, 50 capsules per plastic bottle, SKU: 100-9B
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0181-2020·2019-11-27

    Basic Reset Recalls GH-C Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling GH-C dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was shipped to all 50 states and several foreign countries.

    Product
    GH-C, 60 capsules per plastic bottle, SKU: 100-4F
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0171-2020·2019-11-27

    Basic Reset Recalls Trim Up Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling Trim Up dietary supplement bottles because they do not conform to Dietary Supplement CGMP regulations.

    Product
    TRIM UP DIETARY SUPPLEMENT 80 capsules per plastic bottle, SKU: 100-5A
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0515-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Vials Due to Processing Controls

    Conversio Health is recalling Albuterol and Ipratropium inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5052.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0497-2020·2019-11-27

    Washington Homeopathic Products Recalls Kali Phosphoricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 417 bottles of Kali Phosphoricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0504-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters

    Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0502-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0496-2020·2019-11-27

    Washington Homeopathic Products Recalls Kali Muriaticum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Kali Muriaticum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64194 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0504-2020·2019-11-27

    Washington Homeopathic Products Recalls Pareira Tincture for Manufacturing Deviations

    Washington Homeopathic Products is recalling Pareira (Brava) 1X Tincture because it was not manufactured under current good manufacturing practices.

    Product
    Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0170-2020·2019-11-27

    Basic Reset Recalls Beta Factor Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling 262 bottles of Beta Factor dietary supplement because the product does not conform to Dietary Supplement CGMP regulations.

    Product
    BETA FACTOR DIETARY SUPPLEMENT 60 capsules per plastic bottle, SKU: 100-4F
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0179-2020·2019-11-27

    Basic Reset Recalls AquaLyte Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling AquaLyte dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    AquaLyte, 30g pkg./foil pouch, SKU: 1023
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0500-2020·2019-11-27

    Washington Homeopathic Recalls Natrum Muriaticum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Natrum Muriaticum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2020·2019-11-27

    Washington Homeopathic Products Recalls Magnesia Phosphorica 6X Tablets

    Washington Homeopathic Products is recalling Magnesia Phosphorica 6X tablets because they were not manufactured under current good manufacturing practices.

    Product
    Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2020·2019-11-27

    Cook Inc. Recalls Pneumothorax Trays Due to Sterility Compromise Risk

    Cook Inc. is recalling 41 units of Pneumothorax Trays because a perforation line may be positioned over the sterile area, potentially compromising device sterility.

    Product
    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0173-2020·2019-11-27

    Basic Reset Recalls Vibrant Energy Drink Pouches for CGMP Violations

    Basic Reset Inc. is recalling 6,887 cases of Vibrant Energy Drink 15 g foil pouches because the products do not conform to Dietary Supplement CGMP regulations.

    Product
    Vibrant ENERGY DRINK 15 g foil pouches (15 pack case) 100-4A and 100-4B
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0219-2020·2019-11-27

    Temple Turmeric Recalls Matcha Shots Due to High Yeast Levels

    Temple Turmeric Inc. is voluntarily recalling Temple Pure Prana Matcha+Shot bottles due to high levels of yeast. The recall affects 18,732 units distributed to several states.

    Product
    TEMPLE PURE PRANA MATCHA+SHOT; 3 FL OZ (89mL); VITALITY SUPERBOOST; COLD PRESSURED; PERISHABLE KEEP REFRIGERATED; plastic bottles in 12 pack or 24 pack; UPC 8-54351-00547-0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0507-2020·2019-11-27

    Conversio Health Recalls Formoterol and Budesonide Inhalation Vials

    Conversio Health is recalling Formoterol 12mcg / Budesonide 0.5mg inhalation vials nationwide due to a lack of processing controls.

    Product
    Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials for Processing Defects

    Conversio Health is recalling Albuterol, Ipratropium, and Budesonide inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1239-2020·2019-11-27

    Basic Reset Dino Min Dietary Supplement Recalled for CGMP Non-Compliance

    Basic Reset Inc. is recalling Dino Min dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Dino Min, 60 capsules per plastic bottle, SKU: 100-1C
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0503-2020·2019-11-27

    Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports

    Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.

    Product
    BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0180-2020·2019-11-27

    Basic Reset Recalls Body Mass Reset for CGMP Non-Compliance

    Basic Reset Inc. is recalling Body Mass Reset dietary supplements because they do not conform to Dietary Supplement CGMP regulations.

    Product
    Body Mass Reset, 4 fl. oz. plastic bottle, SKU: 100-8C
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0502-2020·2019-11-27

    Washington Homeopathic Recalls Natrum Sulphuricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Natrum Sulphuricum 6X tablets because they were not manufactured under current good manufacturing practices.

    Product
    Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64193 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2020·2019-11-27

    Washington Homeopathic Recalls Ferrum Phosphoricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Ferrum Phosphoricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64198 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2020·2019-11-27

    Conversio Health Recalls Albuterol and Budesonide Vials Due to Processing Controls

    Conversio Health is recalling Albuterol 2.5mg / Budesonide 0.5mg inhalation vials nationwide due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2020·2019-11-27

    Washington Homeopathic Recalls Calcarea Sulphurica 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Calcarea Sulphurica 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2020·2019-11-27

    Conversio Health Recalls Albuterol and Ipratropium Inhalation Vials

    Conversio Health is recalling Albuterol, Ipratropium, and Budesonide inhalation vials due to a lack of processing controls.

    Product
    Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2020·2019-11-27

    Teva Recalls Valganciclovir Hydrochloride Oral Solution Due to Foreign Particles

    Teva Pharmaceuticals is recalling specific lots of Valganciclovir Hydrochloride for Oral Solution because brown or black particles were found during stability testing.

    Product
    VALGANCICLOVIR HYDROCHLORIDE FOR ORAL — VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0493-2020·2019-11-27

    Hager & Meisinger Recalls Dental Carbide Burs Due to Packaging Error

    Hager & Meisinger is recalling 2,500 dental carbide burs because a 1.0 mm blade may have been packaged in 0.9 mm packaging.

    Product
    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-0519-2020·2019-11-27

    X-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert

    X-Gen Pharmaceuticals is recalling Levetiracetam Injection vials because the incorrect package insert version was attached to the product.

    Product
    Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·20033·2019-11-26

    TJX Stores Sold 19 Recalled Products Including Infant Sleepers and Speakers

    T.J. Maxx, Marshalls, and HomeGoods sold about 1,200 units of 19 previously recalled products, including infant sleepers and speakers. Consumers should stop using these items and contact the manufacturers for remedies.

    Product
    19 different recalled products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E080000·2019-11-26

    Takata Recalls Non-Azide Driver Air Bag Inflators for Moisture Absorption

    Takata is recalling specific non-azide driver air bag inflators used in 1995-2000 vehicles. The inflators may absorb moisture, risking rupture or underinflation during a crash.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V849000·2019-11-26

    Volvo Recalls 2011-2017 Models Due to Door Latch Defect

    Volvo is recalling 2011-2017 S60 and V60 models because a door latch component may break, potentially allowing doors to open while driving.

    Product
    VOLVO — VOLVO V60, S60, V60CC, S60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20031·2019-11-26

    Mark Feldstein Recalls Stacked Gourd Jack-O-Lanterns Due to Fire Hazard

    Mark Feldstein & Associates is recalling Stacked Gourd Jack-O-Lantern decorations because the internal wiring can overheat and ignite. Four reports of smoking or fire have been received.

    Product
    Stacked Gourd Jack-O-Lantern decorations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V848000·2019-11-26

    Forest River Recalls 2020 XLR Boost Trailers Due to Axle Defect

    Forest River is recalling 2020 XLR Boost trailers because an undersized axle and tire combination may cause the trailer to be overloaded, increasing the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V852000·2019-11-26

    BMW Recalls 1999-2000 Models for Driver Air Bag Inflator Defect

    BMW is recalling 1999-2000 323i, 328i, 323Ci, and 328Ci vehicles because driver air bag inflators may rupture or underinflate in a crash, increasing injury risk.

    Product
    BMW — BMW 323I, 328I, 328CI, 323CI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V853000·2019-11-26

    BMW Recalls 1999-2001 3-Series Vehicles for Driver Air Bag Inflator Defect

    BMW is recalling 1999-2001 3-Series vehicles because a replacement driver air bag inflator may absorb moisture, potentially causing it to rupture or underinflate during a crash.

    Product
    BMW — BMW 328I, 323CI, 325CI, 328CI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20710·2019-11-26

    Yamaha Recalls Portable Generators Due to Fire and Burn Hazards

    Yamaha is recalling 2018 and 2019 EF2000iS portable generators because the fuel tank can leak gasoline, posing fire and burn hazards.

    Product
    2018 and 2019 Yamaha EF2000iS portable generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V846000·2019-11-25

    Entegra Recalls 2018-2020 Qwest Motorhomes for Propane Tank Defect

    Entegra is recalling 2018-2020 Qwest motorhomes because defective propane tank hangers may allow the tank to dislodge, increasing crash and fire risk.

    Product
    ENTEGRA — ENTEGRA QWEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V845000·2019-11-25

    Jayco Melbourne Prestige Motorhomes Recalled for Propane Tank Defect

    Jayco is recalling 2018-2020 Melbourne Prestige motorhomes because defective propane tank hangers may allow the tank to dislodge, increasing crash and fire risk.

    Product
    JAYCO — JAYCO MELBOURNE PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V844000·2019-11-25

    Forest River Recalls 2018-2020 Cascade and Cherokee Travel Trailers

    Forest River is recalling 2018-2020 Cascade and Cherokee travel trailers because the trailer hitch coupler may fail, potentially causing the trailer to detach from the tow vehicle.

    Product
    FOREST RIVER — FOREST RIVER CASCADE, CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·pha-112219·2019-11-22

    USDA Issues Public Health Alert for Romaine Lettuce from Salinas, California

    USDA FSIS issued a public health alert for romaine lettuce from the Salinas, California, growing region due to E. coli O157:H7 illnesses. Consumers should not eat or sell affected products.

    Product
    Missa Bay LLC — FSIS Issues Public Health Alert for Products Produced With Romaine From the Salinas, California, Growing Region
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V842000·2019-11-22

    TransTech School Buses Recalled for Roof Hatch Handle Defect

    Transportation Collaborative is recalling 2019-2020 TransTech school buses because the roof hatch handle may break, preventing emergency exit.

    Product
    TRANS TECH — TRANS TECH SST, CST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·117-2019·2019-11-22

    Ajinomoto Recalls Chicken Fried Rice Due to Plastic Contamination

    Ajinomoto Foods North America is recalling frozen chicken fried rice products due to possible plastic contamination. No illnesses have been reported.

    Product
    Ajinomoto Foods North America — Ajinomoto Foods North America, Inc. Recalls Chicken Fried Rice Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • CriticalUSDA FSIS·115-2019·2019-11-21

    Missa Bay Recalls Salad Products Due to Possible E. coli O157:H7 Contamination

    Missa Bay LLC is recalling approximately 75,233 pounds of salad products containing meat or poultry because the lettuce ingredient may be contaminated with E. coli O157:H7.

    Product
    Missa Bay LLC — Missa Bay, LLC Recalls Salad Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    22 states
  • SevereNHTSA·19V838000·2019-11-21

    Navistar Recalls 2020 International HV Trucks for Brake Valve Defect

    Navistar is recalling 2020 International HV 6X4 vehicles because a non-Quick Release Modulator Valve may increase brake release time, raising the risk of brake or tire fires.

    Product
    INTERNATIONAL — INTERNATIONAL HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V837000·2019-11-21

    GM Recalls 2020 Vehicles for Fuel Pump Pressure Regulator Defect

    General Motors is recalling 2020 Cadillac, Chevrolet, and GMC vehicles because a missing fuel pump pressure regulator may cause over-pressurization and fire risk.

    Product
    GMC — GMC, CADILLAC, CHEVROLET YUKON XL, ESCALADE ESV, SIERRA 1500, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·116-2019·2019-11-21

    Morris Meat Packing Recalls Raw Pork Produced Without Federal Inspection

    Morris Meat Packing is recalling approximately 515,000 pounds of raw pork products produced without federal inspection. The products were distributed in Illinois.

    Product
    Morris Meat Packing — Morris Meat Packing Recalls Pork Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighCPSC·20029·2019-11-21

    SCARPA Recalls Maestrale Ski Boots Due to Shell Cracking Hazard

    SCARPA is recalling Maestrale RS and Maestrale men's ski boots because the shells can crack, posing a fall hazard. No injuries have been reported.

    Product
    Maestrale RS and Maestrale Men's Ski Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V839000·2019-11-21

    Ford Recalls 2019 Rangers Due to Rear Light Connector Issues

    Ford is recalling 2019 Ranger trucks because rear light connectors may be misaligned, causing lights to fail and increasing crash risk.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V840000·2019-11-21

    Land Rover Recalls 2020 Range Rover Evoque for Headliner Plate Defect

    Jaguar Land Rover is recalling 2020 Range Rover Evoque vehicles because a metal plate on the headliner may detach during a crash, increasing injury risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V841000·2019-11-21

    Navistar Recalls International Trucks Due to Parking Brake Failure Risk

    Navistar is recalling specific International trucks because engaging the PTO switch can override the parking brake, causing unintended movement.

    Product
    INTERNATIONAL — INTERNATIONAL DURASTAR, WORKSTAR, HV, MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0145-2020·2019-11-20

    Frozen Cookie Doughballs Recalled Due to Allergic Reaction Complaint

    California New Foods is recalling Carolyn's Cookie Company Frozen Cookie Doughballs after a consumer reported an allergic reaction.

    Product
    Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Snickerdoodle Net Wt. 22 oz. (623.7g) UPC Code 680569160317
    Category
    Food
    Distribution
    2 states

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