The Recall Desk

Archive

April 2020 recalls

605 recalls were announced in April 2020.

What the numbers show

Critical
6
Severe
113
High
182
Moderate
294
Low
10

Of the 605 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

Which agencies issued them

501–600 of 605

  • HighFDA (Devices)·Z-1561-2020·2020-04-01

    Dexcom G5 and G4 PLATINUM Systems Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.

    Product
    Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1548-2020·2020-04-01

    Carroll-Baccari Recalls LemonPrep Tubes and Cups Due to Bacterial Contamination

    Carroll-Baccari, Inc. is recalling LemonPrep Tubes and Single use cups because samples tested positive for Burkholderia cepacia during an FDA inspection.

    Product
    LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2020·2020-04-01

    Capintec Captus 4000e Thyroid Uptake System Recall for Collimator Defect

    Capintec is recalling Captus 4000e Thyroid Uptake Systems because insufficiently tapped screw holes may allow the collimator assembly to fall and contact patients or operators.

    Product
    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2020·2020-04-01

    RayStation software recall due to virtual wedge field limitations

    RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.

    Product
    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. Aft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2020·2020-04-01

    Dexcom G4 Platinum Recall Due to Hydroxyurea Interference

    Dexcom Inc is recalling G4 PLATINUM systems because hydroxyurea use may cause falsely elevated glucose readings.

    Product
    Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1586-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 27 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0856-2020·2020-04-01

    WinCo Foods Recalls Frozen Blackberries Due to Norovirus Contamination

    WinCo Foods is recalling 16-ounce bags of frozen blackberries found to be adulterated with Norovirus. The product was distributed in ten western and central states.

    Product
    WinCo Foods frozen Blackberries, item # 107414, packaged in polyethylene bags, with a net weight of 16 oz (1 lb or 454g). UPC: 70552 30502. Product is distributed by WinCo Foods, LLC, Boise, ID 83704. The label is read in parts: "***WinCo Foods***Blackberries*** INGREDIENTS:
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1546-2020·2020-04-01

    Medline Recalls Sterile Syringes Due to Packaging Seal Voids

    Medline Industries is recalling 3,690 units of sterile 3mL syringes because voids in the packaging seal caused a loss of sterility.

    Product
    Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2020·2020-04-01

    Biomet Recalls Misidentified 9mm Shoulder Mini Humeral Stem Implants

    Biomet is recalling 14 units of 9mm Shoulder Mini Humeral Stems that were misidentified as 15mm units. The error poses a risk of improper surgical implantation.

    Product
    Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1551-2020·2020-04-01

    Carroll-Baccari Recalls Wave Prep Tubes and Cups Due to Contamination

    Carroll-Baccari, Inc. is recalling Wave Prep Tubes and single-use cups found to be contaminated with Burkholderia cepacia during an FDA inspection.

    Product
    Wave Prep Tubes (1710-03) and single use cups (17--00-24)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2020·2020-04-01

    LivaNova VNS Therapy Programmer Recall Due to False Positive Warning Risk

    LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.

    Product
    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Food)·F-0915-2020·2020-04-01

    Southern Sisters Gourmet Shrimp and Grits Recalled for Undeclared Milk

    Southern Sisters Gourmet is recalling Shrimp and Stone-Ground Grits due to undeclared milk and colors. The product was distributed in nine southern states.

    Product
    Southern Sisters Gourmet Shrimp and Stone-Ground Grits, Seasoning - Net Wt: 12 g, Grits - Wt: 8 ounces
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0917-2020·2020-04-01

    Southern Sisters Gourmet Taco Soup Recalled for Undeclared Allergens

    Southern Sisters Gourmet Taco Soup is being recalled because it contains undeclared milk and soy. The product was distributed in nine states.

    Product
    Southern Sisters Gourmet Taco Soup, Net Wt- Pkg 1: 191.65 g, Pkg 2: 8 ounces
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1562-2020·2020-04-01

    Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.

    Product
    Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1581-2020·2020-04-01

    Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 64,174 MiniMed Insulin Pumps (model MMT-508) due to potential cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    MiniMed Insulin Pump, model # MMT-508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2020·2020-04-01

    Karl Storz Flexible Pediatric Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1532-2020·2020-04-01

    Karl Storz Fiberscope Recall Due to Incorrect Sterilization Instructions

    Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1528-2020·2020-04-01

    Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk

    Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.

    Product
    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 72,850 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2020·2020-04-01

    Abbott Precision Xtra Blood Glucose Meters Recalled for Uncleared Disinfection Instructions

    Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.

    Product
    Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1580-2020·2020-04-01

    Abbott Alinity ci-series Software Recalled for Performance Issues

    Abbott is recalling Alinity ci-series software version 2.6.2 and earlier due to identified potential performance issues.

    Product
    LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2020·2020-04-01

    Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions

    Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.

    Product
    Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 74,496 MiniMed Paradigm Insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    MiniMed Paradigm Insulin pump, model number MMT-712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 36,143 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2020·2020-04-01

    Bard PowerPort isp MRI Implantable Port Recall for Incorrect Catheter Barb Tip

    Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 225,498 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 17 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2020·2020-04-01

    Abbott FreeStyle Precision H Blood Glucose and Ketone Meter Recall

    Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may lead to infection.

    Product
    FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1559-2020·2020-04-01

    Intellijoint Navigation System Software Recalled for Incorrect Knee Surgery Calculations

    Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.

    Product
    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2020·2020-04-01

    Karl Storz Flexible Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz is recalling 42 flexible neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz, Model # 11161C2, Flexible Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1549-2020·2020-04-01

    Mavidon Recalls PediaPrep Tubes and Cups Due to Bacterial Contamination

    Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.

    Product
    PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2020·2020-04-01

    Medtronic MiniMed Paradigm Veo Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 2,322 Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 10 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2020·2020-04-01

    Medline Recalls Winged Sponges Due to Packaging Seal Voids

    Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of sterility.

    Product
    Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2020·2020-04-01

    Hill-Rom Recalls NaviCare Patient Safety Software Due to Bed Exit Mechanism Failure

    Hill-Rom Inc. is recalling NaviCare Patient Safety Software versions 3.5.400-3.9.300 because a software issue may cause the patient bed exit mechanism to fail to monitor or control.

    Product
    NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (fi
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1578-2020·2020-04-01

    Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0850-2020·2020-04-01

    Proxy Foods Recalls White Corn Hominy Due to Missing Production Records

    Proxy Foods LLC is recalling 96 jars of White Corn Hominy in Oregon and Washington because production logs are missing.

    Product
    White Corn Hominy, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). UPC 738283379147. The label is read in parts: "***WHITE CORN HOMINY ***INGREDIENTS: Water, White Corn Hominy, Sea Salt, Lime Juice ***Made by Proxy Foods, LLC 7328 SE Foster Road,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1069-2020·2020-04-01

    Advil Liqui-Gel Mini Recalled for Missing Safety Warnings

    Glaxosmithkline is recalling specific lots of Advil Liqui-Gel Mini because the Drug Facts Panel lacks required safety warning information.

    Product
    Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0905-2020·2020-04-01

    Touchstone Essentials Super Greens Juice Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Touchstone Essentials Super Greens Juice due to the presence of the unapproved herbicide Haloxyfop in an ingredient.

    Product
    Touchstone Essentials Super Greens Juice - Raspberry Apple; Premium Organic Superfood Juice Powder: Whole Food Dietary Supplement; Net Wt. 10.5 oz. (300 g) Plastic Bottle; Finished Product Item#: FTSGJRA300G Manufactured Exclusively for: Touchstone Essentials, Raleigh, NC
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0862-2020·2020-04-01

    American Classic Snack Company Recalls Sweet Bourbon Crunchers Pretzels

    American Classic Snack Company is recalling Sweet Bourbon Crunchers Pretzels because they are improperly labeled with a gluten-free claim.

    Product
    American Classic Snack Company Sweet Bourbon Crunchers Pretzels in 8 oz. bags, 12 bags per case.
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1552-2020·2020-04-01

    Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error

    Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.

    Product
    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-0904-2020·2020-04-01

    Pure Planet Organic Parasite Cleanse Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Pure Planet Organic Parasite Cleanse because the flaxseed powder ingredient contains the unapproved herbicide Haloxyfop.

    Product
    Pure Planet Organic Parasite Cleanse; Net Wt. 174g Glass Jar; Finished Product Item # 52700 Manufactured and Distributed by: Pure Planet, Rancho Dominguez, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2020·2020-04-01

    Medtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall

    Medtronic is recalling two Open Pivot Aortic Valve Grafts because the outer box was mislabeled as Aortic while the device was Mitral.

    Product
    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1579-2020·2020-04-01

    Bard PowerFlow Apheresis IV Port Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 296 PowerFlow Implatable Apheresis IV Ports because they may contain an incorrect tunneler tip, potentially prolonging surgical operations.

    Product
    PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0897-2020·2020-04-01

    Nested Naturals Super Kids Powder Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Nested Naturals Super Kids powder because the flaxseed ingredient contains an unapproved herbicide.

    Product
    Nested Naturals Super Kids; Superfood Powder Full of Nutrients for Growing Bodies; Whole Food Powder, Net Wt. 7.5 oz (210g), 30 servings; Finished Product Item # FNNKFMSG210G; Bulk Finished Product Item # FGBPNNKFMSG Distributed by Nested Naturals Vancouver, BC, Canada
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0903-2020·2020-04-01

    Springboard Green Power Recalled for Unapproved Herbicide Contamination

    Organic By Nature, Inc. is recalling Springboard Green Power dietary supplements because the flaxseed ingredient contains an unapproved herbicide.

    Product
    Springboard Green Power, Dietary Supplement; 240g Plastic Bottle; Finished Product Item# FSBPGO240G Springboard, Spring Valley, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0899-2020·2020-04-01

    Purim Daily Fiber Blend Recalled for Unapproved Herbicide Contamination

    Organic By Nature, Inc. is recalling Purim Daily Fiber Blend because the flaxseed ingredient contains unapproved herbicide Haloxyfop.

    Product
    Purim Daily Fiber Blend - Original unflavored; 540g Plastic Bottle, 180g Plastic Bottle; Finished Product Item#: 2014, 2014-P65, 2015, 2015-P65 Purim - Rancho Dominguez, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1068-2020·2020-04-01

    GlaxoSmithKline Recalls Advil Allergy and Congestion Relief for Missing Warnings

    GlaxoSmithKline is recalling specific lots of Advil Allergy and Congestion Relief because the Drug Facts Panel lacks required safety warning information.

    Product
    Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1544-2020·2020-04-01

    Medline Stick Sponge Presaturated W/PVP Recalled for Packaging Seal Voids

    Medline is recalling Stick Sponge Presaturated W/PVP units due to packaging seal voids that compromise sterility.

    Product
    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1547-2020·2020-04-01

    Randox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values

    Randox Laboratories is recalling Chemistry QC Premium Plus due to incorrect Sodium target values. The error affects quality control accuracy for diagnostic assays.

    Product
    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1599-2020·2020-04-01

    Siemens Atellica CH Ethyl Alcohol Assay Recalled for Calibration Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Ethyl Alcohol assays due to potential positive bias in results within the 10-day calibration interval.

    Product
    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2020·2020-04-01

    BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2020·2020-04-01

    Elekta MOSAIQ Oncology Software Recalled for Unit Labeling Error

    Elekta Impac Software is recalling MOSAIQ oncology software because users may enter metric values into fields labeled with US standard units.

    Product
    MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1570-2020·2020-04-01

    Bard PowerPort Implantable Ports Recalled Due to Incorrect Catheter Barb Tip

    Bard Peripheral Vascular Inc is recalling 178 PowerPort implantable ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgery.

    Product
    1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2020·2020-04-01

    Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Direct Bilirubin assays because they may show inaccurate results for patients taking eltrombopag.

    Product
    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2020·2020-04-01

    Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.

    Product
    Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2020·2020-04-01

    T.A.G. Medical Recalls FlipCutter III Drills Due to Sterile Barrier Risk

    T.A.G. Medical Products is recalling 6,625 FlipCutter III Drills because cracked blister trays may compromise the sterile barrier, posing a risk of particulate contamination.

    Product
    FlipCutter III Drill
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0902-2020·2020-04-01

    Organic By Nature Recalls RAWr! Life Superfoods Due to Unapproved Herbicide

    Organic By Nature is recalling RAWr! Life Organic Superfoods because the flaxseed powder ingredient contains an unapproved herbicide.

    Product
    RAWr! Life Organic Superfoods; Dietary Supplement; 300g Plastic Bottle (10.60 oz.); Finished Product Item # FHEEG300G Rawr! Life, Glendale, AZ 85308
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0848-2020·2020-04-01

    Proxy Foods Recalls Red Pozole Soup Starter Due to Missing Records

    Proxy Foods LLC is recalling Red Pozole Soup Starter because of missing production logs and observations of swollen or leaking jars.

    Product
    Red Pozole Soup Starter, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). or 24 fl. oz. 16 fl oz UPC 738283379109 24 fl oz UPC 860322002201 The label is read in parts: "***RED POZOLE SOUP STARTER ***NET WT. 24 OZ. ***INGREDIENTS: Water, Hominy,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0898-2020·2020-04-01

    Organic By Nature Daily Fiber Blend Recalled for Unapproved Herbicide

    Organic By Nature is recalling Daily Fiber Blend - Caramel Apple Flavor because the flaxseed powder ingredient contains unapproved herbicide Haloxyfop.

    Product
    Daily Fiber Blend - Caramel Apple Flavor; Organic Plant Powder Mix for preparation of a fiber-rich drink, 540g Plastic Bottle, 180g Bio Bag Terra Pouch; Finished Product Item#: 2012E, 2012, 2012-P65, 2013, 2013-P65, 2016, 2016-P65 Brand names of: Platinum Health Europe, Ne
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0847-2020·2020-04-01

    Aseltines Apple Cider Recalled for Excessive Patulin Levels

    Aseltines is recalling 100% Apple Cider in 1/2 gallon and 1 gallon sizes because testing revealed patulin levels exceeding 50 ppb.

    Product
    Aseltines 100% JUICE Apple Cider 1/2 gallon UPC 5169600064 and 1 gallon UPC 5169600128
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0895-2020·2020-04-01

    Organic By Nature Chia/Flax Boost Recalled for Unapproved Herbicide

    Organic By Nature is recalling Chia/Flax Boost dietary supplements because the flaxseed powder contains unapproved herbicide Haloxyfop.

    Product
    care/of Chia/Flax Boost Dietary Supplement; Net Wt. 0.35 oz. (10g) foil packets; Finished Product Item # FCOFBP10G Distributed by Noho Health Inc., New York, NY 10013
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2020·2020-04-01

    Siemens ADVIA Chemistry Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Total Bilirubin assays because they may show falsely high results for patients taking eltrombopag.

    Product
    ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2020·2020-04-01

    Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference

    Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high results for patients taking eltrombopag.

    Product
    Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0894-2020·2020-04-01

    Alkamind Creamy Vanilla Organic Daily Protein Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Alkamind Creamy Vanilla Organic Daily Protein because the flaxseed powder ingredient contains unapproved herbicide Haloxyfop.

    Product
    Alkamind Creamy Vanilla Organic Daily Protein; 450g Plastic Bottle; Finished Product Item # FAMVDP450G; 3 core alkaline proteins Distributed by Alkamind LLC, New York, NY 10028
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0893-2020·2020-04-01

    Alkamind Creamy Chocolate Protein Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Alkamind Creamy Chocolate Organic Daily Protein due to the presence of unapproved herbicide Haloxyfop in the flaxseed powder ingredient.

    Product
    Alkamind Creamy Chocolate Organic Daily Protein; 450g Plastic Bottle; Finished Product Item # FAMCDP450G; 3 core alkaline proteins Distributed by Alkamind LLC, New York, NY 10028
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0900-2020·2020-04-01

    Organic By Nature Recalls L.O.V.E. Supermeal Original Due to Unapproved Herbicide

    Organic By Nature, Inc. is recalling L.O.V.E. Supermeal Original products because the organic ground flaxseed powder ingredient was found to contain the unapproved herbicide Haloxyfop.

    Product
    L.O.V.E. Supermeal Original: 420g Plastic Bottle, 1396g Plastic Bottle, 693g Bio Bag Terra Pouch; Finished Product Item # 2700E, 2711, 2712, 2712-P65 Platinum Health Europe, Netherlands, Purim Health Products, Rancho Dominguez, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2020·2020-04-01

    Fresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems

    Fresenius Medical Care is recalling 3,561 Honeywell pressure transducers used in hemodialysis delivery systems due to lower long-term reliability.

    Product
    Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1062-2020·2020-04-01

    Jubilant Draximage Recalls DRAXIMAGE DTPA Kits Due to Stability Failures

    Jubilant Draximage is recalling DRAXIMAGE DTPA kits because they failed stability specifications. The affected product was distributed throughout the United States.

    Product
    DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1568-2020·2020-04-01

    Signature Orthopaedics Recalls Mislabeled Encina HA Femoral Stem Components

    Signature Orthopaedics is recalling five mislabeled Encina HA Femoral Stem components. The packaging error could cause surgical delays if the wrong product is used.

    Product
    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1575-2020·2020-04-01

    BardPort Titanium Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.

    Product
    BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1059-2020·2020-04-01

    Nostrum Recalls Theophylline Tablets Due to Incorrect Lot and Expiration Dates

    Nostrum Laboratories is recalling Theophylline Extended-Release Tablets because poor manufacturing practices resulted in incorrect lot and expiration date labeling.

    Product
    Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1066-2020·2020-04-01

    Advil Liqui-Gel Minis Recalled for Missing Safety Warnings

    Glaxosmithkline is recalling 446,628 bottles of Advil Liqui-Gel Minis because certain lots lack required safety warning information in the Drug Facts Panel.

    Product
    ADVIL — ADVIL (IBUPROFEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1534-2020·2020-04-01

    bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals

    bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.

    Product
    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1574-2020·2020-04-01

    Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0896-2020·2020-04-01

    Organic By Nature Slim Natural Raw Meal Recalled for Unapproved Herbicide

    Organic By Nature is recalling Slim Natural Raw Meal due to the presence of unapproved herbicide Haloxyfop in the flaxseed powder.

    Product
    Erom, Inc. Slim Natural Raw Meal; Bulk; Finished product item # FGBPEIOS-E
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0906-2020·2020-04-01

    Organic Super Protein Vanilla Coconut Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Touchstone Essentials Organic Super Protein Vanilla Coconut due to unapproved herbicide Haloxyfop in the flaxseed ingredient.

    Product
    Touchstone Essentials Organic Super Protein Vanilla Coconut; Whole Food Dietary Supplement; Net Wt. 18.3 oz. (520g) Plastic Bottle; Finished Product Item#: FTEVPVC520G Manufactured Exclusively for: Touchstone Essentials, Raleigh, NC
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1538-2020·2020-04-01

    Siemens ADVIA Chemistry Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in patients taking eltrombopag.

    Product
    ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1577-2020·2020-04-01

    BardPort M.R.I. Hard Base Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 151 BardPort M.R.I. Hard Base Implantable Ports because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0855-2020·2020-04-01

    Caruthers Raisin Packing Recalls Raisins Due to Foreign Material

    Caruthers Raisin Packing Co. is recalling specific brands of raisins because a laser on the processing line detected foreign material during production.

    Product
    Raisins packed in following brand names and sizes: 6 pack cartons (6 X 1 oz. boxes) - Pickwell Farms, Southern Grove, Winco, Schnucks, Essential Everyday, 20 oz. paper canisters; Schnucks, Winco, Essential Everday, Best Yet, Big Y 5 oz. cello bag - Slater Bros.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1065-2020·2020-04-01

    Advil Allergy and Congestion Relief Recalled for Missing Safety Warnings

    Glaxosmithkline is recalling specific lots of Advil Allergy and Congestion Relief tablets because they lack required safety warning information in the Drug Facts Panel.

    Product
    ADVIL ALLERGY AND CONGESTION RELIEF — ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1566-2020·2020-04-01

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Spectrum Central Venous Catheter Trays because the printed expiration dates are incorrect. The devices were distributed to seven US states and Canada.

    Product
    Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1537-2020·2020-04-01

    Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate high results for patients taking eltrombopag.

    Product
    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2020·2020-04-01

    Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2020·2020-04-01

    Nystatin Oral Suspension Recalled for Low Potency

    Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it tested below the required potency level.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0851-2020·2020-04-01

    Corinthian Foods Recalls Sweet Potato Crusted Alaska Pollock Nuggets

    Corinthian Trading Inc. is recalling uncooked sweet potato crusted Alaska pollock nuggets because the product contains chicken nuggets instead of fish.

    Product
    UNCOOKED SWEET POTATO CRUSTED ALASKA POLLOCK NUGGETS 5 LBS 2.26KG DISTRIBUTED BY CORINTHIAN FOODS ST. SIMONS ISLAND, GA 31622 UPC 8 50008 56763 6
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0849-2020·2020-04-01

    Proxy Foods Recalls Green Pozole Soup Starter Due to Missing Records

    Proxy Foods LLC is recalling Green Pozole Soup Starter because the company is missing processing records and production logs for the product.

    Product
    Green Pozole Soup Starter, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). or 24 fl. oz. 16 fl oz UPC 738283379116 24 fl oz UPC 860322002218 The label is read in parts: "***GREEN POZOLE SOUP STARTER ***INGREDIENTS: Water, Hominy, Tomatillo, Po
    Category
    Food
    Distribution
    2 states

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