The Recall Desk

Archive

December 2018 recalls

451 recalls were announced in December 2018.

What the numbers show

Critical
15
Severe
134
High
189
Moderate
96
Low
17

Of the 451 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

201–300 of 451

  • HighFDA (Drugs)·D-0323-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0584-2019·2018-12-19

    GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V905000·2018-12-19

    Mercedes-Benz Recalls 2018-2019 GLC63 Models for Air Bag Delay

    Mercedes-Benz is recalling 2018-2019 GLC63 and GLC63S vehicles because the frontal air bag may deploy late for unbelted passengers, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63S, AMG GLC63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coag
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0605-2019·2018-12-19

    Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.

    Product
    Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V897000·2018-12-19

    Seagrave Recalls 2017-2018 Emergency Vehicles for Brake Light Defect

    Seagrave is recalling 2017-2018 Capital and Marauder II emergency vehicles because Whelen accessory brake lights may falsely illuminate, increasing crash risk.

    Product
    SEAGRAVE — SEAGRAVE CAPITAL, MARAUDER II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2019·2018-12-19

    Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure

    Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.

    Product
    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0583-2019·2018-12-19

    GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues

    GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.

    Product
    CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an altern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V918000·2018-12-19

    BMW Recalls 2019 X5 Models for Missing Air Bag Warning Labels

    BMW is recalling 2019 X5 xDrive40i and xDrive50i vehicles because the sun visors may lack required air bag warning labels, increasing injury risk in crashes.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19055·2018-12-19

    GNC Recalls Women's Iron Complete Supplements Due to Packaging Defect

    GNC is recalling Women's Iron Complete supplements because the blister packaging is not child-resistant, posing a risk of poisoning to children.

    Product
    Women's Iron Complete Dietary Supplement (60 caplets)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0700-2019·2018-12-19

    Imperial Taste Fried Red Onion Recalled for Undeclared Wheat

    Gemini Food Corporation is recalling Imperial Taste Fried Red Onion because an investigation found undeclared wheat in the ingredients.

    Product
    Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 741861017607; 24 x 12oz. Item #1761, UPC Code: 741861017614; Ingredients: Red Onion, Palm Oil Product of Vietnam Distributed by Gemini Food Corporation, City Of Inductry, CA 91789
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-0579-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulatin
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·18V908000·2018-12-19

    Mercedes-Benz Recalls 2018 S-Class Vehicles for Steering Assist Defect

    Mercedes-Benz is recalling 2018 S-Class and AMG S63 vehicles because an incorrect steering boot installation may keep the Active Steering Assist system engaged while the driver's hands are off the wheel.

    Product
    MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 560 4MATIC, AMG S63, S 450, S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0701-2019·2018-12-19

    Fried Garlic Recalled for Undeclared Wheat Ingredient

    Gemini Food Corporation is recalling Imperial Taste Fried Garlic due to undeclared wheat. The product is distributed in multiple states.

    Product
    Imperial Taste Fried Garlic, Tu Phi; 24 x 8oz. Item #1763 UPC Code: 741861017638; 24 x 12oz. Item #1762 UPC Code: 741861017621 Ingredient: Garlic, Palm Oil Product of Vietnam Distributed by Gemini Food Corporation, City of Industry, CA
    Category
    Food
    Distribution
    34 states
  • HighNHTSA·18V910000·2018-12-19

    Mercedes-Benz Recalls S-Class Vehicles for Steering Assist Malfunction

    Mercedes-Benz is recalling 2018-2019 S-Class vehicles because the hands-off detection system may fail, keeping steering assist active without driver input.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, S 450, S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2019·2018-12-19

    Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component

    Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.

    Product
    HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0586-2019·2018-12-19

    GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

    GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2019·2018-12-19

    GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk

    GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V911000·2018-12-19

    Mercedes-Benz Recalls 2019 CLS Models for Headlight Adjustment Defect

    Mercedes-Benz is recalling 2019 CLS 450 and AMG CLS53 vehicles because unsealed headlight adjustment screws may cause improper alignment, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS 450, AMG CLS53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulati
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0704-2019·2018-12-19

    4Patriots Chicken a la King Recalled for Undeclared Milk Allergen

    4Patriots, LLC is recalling Chicken a la King pouches because milk is not declared on the label. The product was sold nationwide in emergency kits.

    Product
    4Patriots Chicken a la King CONTAINS: Wheat, Coconut NET WT. 10.0 oz (284 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2019·2018-12-19

    Feast Mode Garlic Beer Seasoning Recalled for Gluten Free Mislabeling

    Feast Mode Blending & Filling is recalling 5,000 units of Garlic Beer Seasoning because the product is mislabeled as 'Gluten Free'.

    Product
    Feast Mode Flavors Garlic Beer Seasoning, Nt. Wt. 5 oz, plastic bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2019·2018-12-19

    GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0725-2019·2018-12-19

    Jackie's Cookie Babies Recalled for Potential Metal Fragments

    Jackie's Cookie Connection is recalling 9,720 units of Jackie's Cookie Babies Classic Chocolate Chip cookies due to potential metal fragments.

    Product
    Jackie's Cookie Babies Classic Chocolate Chip Net Wt. 28oz Manufactured and distributed by: Jackie's Cookie Connection, 12109 Santa Monica Blvd., Los Angeles, CA 90025 UPC Code 8 55094 00688 5
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0574-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.

    Product
    CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0294-2019·2018-12-19

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0290-2019·2018-12-19

    CAO Group Recalls fas.TRACT Hemostatic Gel Due to cGMP Violations

    CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.

    Product
    fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0293-2019·2018-12-19

    CAO Group Recalls FastStat Topical Hemostat Kits Due to cGMP Violations

    CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.

    Product
    FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2019·2018-12-19

    CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues

    CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.

    Product
    SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0594-2019·2018-12-19

    Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards

    Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.

    Product
    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0592-2019·2018-12-19

    Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall

    Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.

    Product
    IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0570-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0591-2019·2018-12-19

    Zimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error

    Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.

    Product
    Comprehensive Mini Stem, Item No. 113631:
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0602-2019·2018-12-19

    Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear

    Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0569-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0292-2019·2018-12-19

    CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations

    CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.

    Product
    BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0712-2019·2018-12-19

    Gatorade Multipack Recalled Due to Mold Contamination

    The Gatorade Puerto Rico Co is recalling Gatorade Combo multipacks due to mold contamination. Consumers should stop using the affected products.

    Product
    Gatorade Combo (Multipack) 24/600 mL
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0600-2019·2018-12-19

    Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk

    Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.

    Product
    AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0708-2019·2018-12-19

    Gatorade Melon Beverage Recalled Due to Mold Contamination

    The Gatorade Puerto Rico Co is recalling Gatorade Melon beverages due to mold contamination. Consumers should stop using the product.

    Product
    Gatorade, Melon, 20.3 FL OZ, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0571-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling

    CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0575-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.

    Product
    CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0597-2019·2018-12-19

    COVIDIEN Recalls Salem Sump Stomach Tubes Due to Packaging Error

    COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.

    Product
    Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0572-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0573-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0604-2019·2018-12-19

    Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues

    The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative an
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0576-2019·2018-12-19

    CIVCO Sales Demo Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.

    Product
    CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0595-2019·2018-12-19

    Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates

    Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.

    Product
    Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0291-2019·2018-12-19

    CAO Group Recalls SHEER DesenZ Desensitizing Treatment Due to cGMP Violations

    CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.

    Product
    SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0705-2019·2018-12-19

    Gatorade Frost Glacier Freeze Recalled for Mold Contamination

    The Gatorade Puerto Rico Co is recalling Gatorade Frost Glacier Freeze 600 mL bottles due to mold contamination. The recall covers 684 cases distributed to domestic consignees.

    Product
    Gatorade, Frost Glacier Freeze, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0706-2019·2018-12-19

    Gatorade Cool Blue Recalled for Mold Contamination

    The Gatorade Puerto Rico Co is recalling 200 cases of Gatorade Cool Blue due to mold contamination. Consumers should discard the product.

    Product
    Gatorade, Cool Blue, 20.3 FL OZ, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0295-2019·2018-12-19

    QuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient

    QuVa Pharma is recalling 168 bags of Norepinephrine Injection compounded in 5% Dextrose instead of 0.9% Sodium Chloride. The product was distributed in California.

    Product
    Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0599-2019·2018-12-19

    Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage

    Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.

    Product
    AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0711-2019·2018-12-19

    Gatorade Fruit Punch Recalled for Mold Contamination

    The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Fruit Punch 600 mL bottles due to mold contamination.

    Product
    Gatorade, Fruit Punch, 20.3 FL OZ, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0709-2019·2018-12-19

    Gatorade Lemon Lime Recall Issued Due to Mold Contamination

    The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Lemon Lime due to mold contamination. Consumers should check lot numbers and expiration dates.

    Product
    Gatorade, Lemon Lime, 20.3 FL OZ, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0710-2019·2018-12-19

    Gatorade Grape Beverage Recalled Due to Mold Contamination

    The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Grape due to mold contamination. Consumers should discard the affected product.

    Product
    Gatorade, Grape, 20.3 FL OZ, Cont. Neto (600 mL)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0296-2019·2018-12-19

    LGM Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, because the product has inconsistent levels of active ingredients levothyroxine and liothyronine.

    Product
    Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0565-2019·2018-12-19

    CIVCO Biopsy Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.

    Product
    CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0566-2019·2018-12-19

    CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects

    CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.

    Product
    SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0596-2019·2018-12-19

    BioFlo PICC Recall Issued for Incorrect Expiration Date Labeling

    Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.

    Product
    BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0601-2019·2018-12-19

    Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation

    Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.

    Product
    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·123-2018·2018-12-18

    Russ Davis Wholesale Recalls Chicken Wrap Products Due to Undeclared Egg Allergen

    Russ Davis Wholesale is recalling ready-to-eat chicken Caesar wraps because they contain eggs, a known allergen, that is not declared on the label.

    Product
    Russ Davis Wholesale, Inc. — Russ Davis Wholesale, Inc. Recalls Chicken Wrap Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V894000·2018-12-18

    Ford Recalls F-Series Trucks Due to Block Heater Fire Risk

    Ford is recalling 410,289 F-Series trucks because water in the block heater cable can cause corrosion and a fire.

    Product
    FORD — FORD F-150, F-450, redundant F-350, redundant F-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V926000·2018-12-18

    Eldorado Buses Recalled for Back Seat Cushion Locking Defect

    Eldorado is recalling 2017-2018 Arrivo, Passport, and E-Z Rider Max BRT buses because back seat cushions may not stay locked in place during a crash.

    Product
    ELDORADO — ELDORADO ARRIVO, PASSPORT, E-Z RIDER MAX BRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19052·2018-12-18

    TerraTrike Rambler E.V.O. Adult Tricycles Recalled for Crash Hazards

    TerraTrike is recalling about 450 Rambler E.V.O. adult tricycles because the torque sensor can activate unexpectedly, causing the trike to power forward and posing crash and injury hazards.

    Product
    TerraTrike Rambler E.V.O adult tricycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V925000·2018-12-18

    Triple E Recalls 2019 Serenity RVs Due to Battery Fire Risk

    Triple E is recalling 2019 Serenity recreational vehicles because a metal cable may contact the battery terminal, creating a fire hazard.

    Product
    TRIPLE E — TRIPLE E SERENITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V893000·2018-12-17

    Audi Recalls 2018 A5 Sportback for Loose Front Suspension Fasteners

    Volkswagen is recalling 2018 Audi A5 Sportback vehicles because front suspension fasteners may not be sufficiently tightened, which could cause a front wheel to become loose.

    Product
    AUDI — AUDI A5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V896000·2018-12-17

    Heartland Milestone Recalled for Improperly Secured Propane Hose

    Heartland is recalling 2019 Milestone trailers because a propane hose may be improperly secured, posing a fire risk if it contacts the tire.

    Product
    HEARTLAND — HEARTLAND MILESTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V892000·2018-12-17

    Blue Bird Recalls 2017-2019 Vision School Buses for Air Compressor Belt Defect

    Blue Bird is recalling 2017-2019 Vision school buses with specific Cummins engines because a slipping air compressor belt may cause the parking brake to apply while driving, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·122-2018·2018-12-15

    Mannarich Recalls Siluriformes Fish Products Lacking Import Inspection

    Mannarich Food, Inc. is recalling approximately 145,245 pounds of Siluriformes fish products that were imported from Malaysia without U.S. inspection.

    Product
    Mannarich Food, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V889000·2018-12-14

    Autocar Recalls 2019 Xpeditor Vehicles Due to Loose Driveline Bolts

    Autocar is recalling 2019 Xpeditor vehicles because universal joint strap bolts may not be properly tightened, which could cause the drive shaft to detach and increase crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V891000·2018-12-14

    Hyundai Recalls 2018 Elantra GT for Sunroof Obstacle Detection Defect

    Hyundai is recalling 2018 Elantra GT vehicles because the panoramic sunroof motor may be incorrectly programmed, preventing it from detecting obstacles while closing.

    Product
    HYUNDAI — HYUNDAI ELANTRA GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E115000·2018-12-13

    Lifeworks Recalls Heated Seat Cushions and Blankets Due to Fire Risk

    Lifeworks is recalling specific Armor All heated seat cushions and blankets sold at Meijer because they may overheat and melt, posing a fire and injury risk.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V888000·2018-12-13

    Toyota Recalls 2018-2019 Tacoma Vehicles Due to Brake Master Cylinder Defect

    Toyota is recalling 2018-2019 Tacoma vehicles because improper machining of the brake master cylinder may damage internal seals, potentially reducing brake performance and increasing crash risk.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V887000·2018-12-13

    Toyota Recalls Land Cruiser and Lexus LX 570 for Air Bag Deactivation Risk

    Toyota is recalling 2008-2019 Land Cruiser and Lexus LX 570 vehicles because a broken wire harness may deactivate front passenger air bags, increasing injury risk in crashes.

    Product
    TOYOTA — TOYOTA, LEXUS LAND CRUISER, LX570
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V890000·2018-12-13

    Frazer Recalls 2017-2018 Ambulances Due to Brake Light Wiring Issue

    Frazer is recalling 2017-2018 Type 1 and Type 3 ambulances and Mobile Stroke Units because Whelen accessory brake lights may illuminate without the brake pedal being pressed.

    Product
    FRAZER — FRAZER TYPE 1 AMBULANCE, TYPE 3 AMBULANCE, MOBILE STROKE UNIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19050·2018-12-13

    TJX Recalls Glass and Ceramic Drawer Knobs Due to Laceration Hazard

    TJX is recalling glass and ceramic drawer knobs sold at T.J. Maxx, Marshalls, and HomeGoods because they can shatter when pulled, posing a laceration hazard.

    Product
    Glass and ceramic drawer knobs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·121-2018·2018-12-13

    Vermont Packinghouse Recalls Raw Bone-In Beef Quarters Due to Specified Risk Materials

    Vermont Packinghouse is recalling raw bone-in beef quarters from cattle over 30 months old due to possible specified risk materials contamination.

    Product
    Vermont Packinghouse, LLC Recalls Raw Intact Bone-In Beef Products due to Possible Specified Risk Materials Contamination
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0549-2019·2018-12-12

    Invacare Hydraulic Patient Lifts Recalled for Potential Caster Separation

    Invacare is recalling 73,703 hydraulic patient lifts because a mounting bolt may loosen, causing the caster to separate and the lift to tilt.

    Product
    Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0463-2019·2018-12-12

    GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards

    GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.

    Product
    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V883000·2018-12-12

    Toyota, Lexus, and Pontiac Recall Vehicles Due to Air Bag Inflator Defect

    Toyota, Lexus, and Pontiac are recalling specific 2002-2007 vehicles because passenger air bag inflators may explode during deployment, posing a risk of serious injury.

    Product
    PONTIAC — PONTIAC, LEXUS, TOYOTA VIBE, SC, SEQUOIA, COROLLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0751-2019·2018-12-12

    Green Cedar Ackawi cheese recalled due to Listeria monocytogenes contamination

    Harb Dairy is voluntarily recalling Green Cedar Ackawi cheese in Michigan after FDA and state officials confirmed the product tested positive for Listeria monocytogenes.

    Product
    Green Cedar Ackawi cheese in small clear plastic shrink wrapped packaging bearing a sell by date of March 26, 2019 or later. The sell by date is on a white sticker on the back of the product. , Keep Refrigerated
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0717-2019·2018-12-12

    Jay Robb Unflavored Egg White Protein Recalled for Undeclared Milk

    Agropur MSI Ingredients LLC is recalling Jay Robb Unflavored Egg White Protein due to undeclared milk. The recall covers 1,956 pouches distributed nationwide.

    Product
    Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5lbs) 680g. Dietary Supplement. UPC 03907-00492. Jay Robb, Inc., Jupiter, FL 33458
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0544-2019·2018-12-12

    Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk

    Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and displa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V884000·2018-12-12

    Blue Bird Recalls School Buses Due to Brake and Fuel Line Fire Risk

    Blue Bird is recalling 2013-2020 Vision school buses because improperly routed brake lines and shifter cables may cause fluid or fuel leaks, increasing fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0737-2019·2018-12-12

    Ottogi Jin Ramen Mild Recalled for Undeclared Egg Allergen

    Ottogi America Inc. is recalling Ottogi Jin Ramen Mild 5-packs due to an undeclared egg allergen. The product was distributed in five U.S. states and Canada.

    Product
    Ottogi Jin Ramen Mild NET WT. 1lb 5.16oz, 600g (120gx5) 5PK Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0536-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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