The Recall Desk

Archive

September 2019 recalls

454 recalls were announced in September 2019.

What the numbers show

Critical
36
Severe
124
High
216
Moderate
64
Low
14

Of the 454 recalls this month scored against our rubric, 8% are Critical, 27% are Severe.

Which agencies issued them

401–454 of 454

  • HighFDA (Food)·F-2111-2019·2019-09-04

    Olive Bakery Recalls White Bean Bread for Wheat Allergen Mislabeling

    Olive Bakery is recalling White Bean bread because the label lists flour but fails to declare wheat, a major allergen. The product was distributed in Oregon and Washington.

    Product
    White Bean bread is filled with white bean paste filling and topped with black sesame seeds, two pieces are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white pr
    Category
    Food
    Distribution
    2 states
  • HighCPSC·19778·2019-09-04

    John Deere Recalls Frontier Grooming Mowers Due to Entanglement Hazard

    John Deere is recalling Frontier grooming mowers because incorrect driveline assembly can prevent the safety shield from spinning, posing an entanglement injury risk.

    Product
    Frontier FM3012, GM1060, GM1072, GM1084, GM1190, GM3060, and GM3072 grooming mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2019·2019-09-04

    Siemens SOMATOM go.Now CT Systems Recalled for Injector Holder Risk

    Siemens is recalling SOMATOM go.Now CT systems because the injector holder could fall off with the injector and storage box.

    Product
    SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2108-2019·2019-09-04

    PreGel Lemon 50 Recalled for Undeclared Milk Allergen

    PreGel America, Inc. is recalling PreGel Lemon 50 because a complaint indicated the presence of undeclared milk, which is not listed on the ingredient statement.

    Product
    PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-2115-2019·2019-09-04

    Olive Bakery Recalls Bavarian Bread Packages for Allergen Mislabeling

    Olive Bakery is recalling three packages of Bavarian bread pastries because the label fails to declare wheat and soy lecithin.

    Product
    Bavarian bread packages contain two bread pastries filled with Bavarian cream filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing lab
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2110-2019·2019-09-04

    Olive Bakery Green Bean Bread Recalled for Undeclared Wheat Allergen

    Olive Bakery is recalling Green Bean bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Green Bean bread topped with black sesame seeds, packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and reads in part: ***Olive bakery ***Ingredie
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2113-2019·2019-09-04

    Olive Bakery Cream Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling cream bread packages because the label fails to declare wheat and soy lecithin, posing a risk to consumers with allergies.

    Product
    Cream bread packages contain two bread pastries filled with custard filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing label and read
    Category
    Food
    Distribution
    2 states
  • HighCPSC·19776·2019-09-04

    John Deere Recalls XUV835 Gator Utility Vehicles Due to Throttle Hazard

    John Deere is recalling about 19,730 XUV835 Gator utility vehicles because the throttle cable sheathing can melt, causing the throttle to stick and posing a crash hazard.

    Product
    John Deere XUV835 Gator utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2019·2019-09-04

    Becton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns

    Becton Dickinson is recalling 700 units of Jamshidi Crown Bone Marrow biopsy needles because product pouches may not be sealed properly, potentially compromising sterility.

    Product
    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-2117-2019·2019-09-04

    Olive Bakery Peanut Butter Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling Peanut Butter Bread packages because the label fails to declare wheat and soy lecithin. The product was distributed in Oregon and Washington.

    Product
    Peanut Butter bread packages contain two bread pastries filled with peanut butter filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing l
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2114-2019·2019-09-04

    Olive Bakery Mocha Cream Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling Mocha Cream bread packages in Oregon and Washington because the labels fail to declare wheat, almond, and soy lecithin.

    Product
    Mocha Cream bread packages contain two bread pastries and each filled with a coffee filling with almonds on the outside. No net weight or nutritional information is included on the label. The packaging contains white printing label and reads in part: ***Olive bakery ***Ingredi
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2119-2019·2019-09-04

    Olive Bakery Sweet Potato Bread Recalled for Wheat Mislabeling

    Olive Bakery is recalling three packages of Sweet Potato Bread because the label lists flour but fails to declare wheat, a major allergen.

    Product
    Sweet Potato bread packages contain two bread pastries filled with white bean paste filling topped with black sesame seeds and cinnamon. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the la
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2092-2019·2019-09-04

    Whole Foods Recalls 365 Organic Pecan Oatmeal for Undeclared Allergen

    Whole Foods Market is recalling 365 Organic Maple & Brown Sugar Pecan Instant Oatmeal cups due to undeclared pecans. The product was distributed in Washington, Idaho, and Oregon.

    Product
    365 Organic Maple & Brown Sugar Pecan Instant Oatmeal 2.3 oz (65 g) microwaveable cups that are sold individually
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2380-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 46 units of Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2376-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2372-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2402-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Recall for Falling Injector Holder

    Siemens is recalling 10 SOMATOM go.All CT scanners because the injector holder could fall off. The units are distributed in 20 US states.

    Product
    SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling 18 SOMATOM go.Up CT systems because the injector holder could fall off, posing a risk of injury.

    Product
    SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling Equistream XK Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2413-2019·2019-09-04

    Stryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity

    Stryker GmbH is recalling 476 Endotrac ECTR Push Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1846-2019·2019-09-04

    Alkermes Recalls Vivitrol Kits Due to Incorrect Needle Packaging

    Alkermes is recalling 6,514 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not impacted.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2019·2019-09-04

    Stryker Recalls Endotrig ETF Hook Blades Due to Sterile Seal Concerns

    Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2397-2019·2019-09-04

    Phadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error

    Phadia Ab is recalling 387 Phadia 1000 immunodiagnostic instruments due to a liquid sensor error. The recall affects facilities in 27 US states.

    Product
    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2424-2019·2019-09-04

    Stryker Recalls Endintrak 2 Hook Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 259 Endintrak 2 Hook Blade kits because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gast
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2019·2019-09-04

    Ad-Tech Medical Recalls Subdural Electrodes Due to Incorrect MR Safety Labeling

    Ad-Tech Medical Instrument Corporation is recalling subdural electrodes because supplemental information incorrectly stated they were approved for use in MRI environments.

    Product
    Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2019·2019-09-04

    Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2423-2019·2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2414-2019·2019-09-04

    Stryker Endotrac ECTR Triangle Blade Recalled Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 53 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2019·2019-09-04

    Ad-Tech Skull Anchor Bolts Recalled for Incorrect MRI Approval Labeling

    Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.

    Product
    Skull Anchor Bolts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2358-2019·2019-09-04

    Medline Recalls Sterile Piston Irrigation Syringe Trays Due to Packaging Defects

    Medline Industries is recalling 11,962 sterile piston irrigation syringe trays because samples showed incomplete or open packaging seals.

    Product
    Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2091-2019·2019-09-04

    PepsiCo Recalls Diet Mountain Dew Bottles Mislabeled as Full Calorie

    PepsiCo is recalling 1,000 units of Diet Mountain Dew promotional bottles in Michigan because the label states 'Diet' but the product is actually full-calorie Mountain Dew.

    Product
    Diet Mountain Dew (Dewnited Michigan) 20 oz. plastic bottle Promotional give away as individual units
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2359-2019·2019-09-04

    Agilent MassHunter Software Recall Due to Sample Data Mismatch

    Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.

    Product
    MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2019·2019-09-04

    Leventon DOSI-FUSER Infusion Pumps Recalled for Lack of FDA Clearance

    Leventon S. A. U. is recalling DOSI-FUSER infusion pumps because they lack FDA 510(k) clearance, making them misbranded.

    Product
    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2407-2019·2019-09-04

    Ad-Tech Medical Recalls Depth Electrodes Due to Incorrect MR Safety Labeling

    Ad-Tech Medical Instrument Corporation is recalling depth electrodes because supplemental information incorrectly stated they were approved for use in the MR environment.

    Product
    Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns

    Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2019·2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 2,248 Endotrac EPF/EGR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2410-2019·2019-09-04

    DRG Salivary Progesterone ELISA Kit Recalled for Low Result Bias

    DRG Instruments GmbH is recalling 8 kits of Salivary Progesterone HS ELISA due to significantly lower results in low measuring ranges.

    Product
    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2432-2019·2019-09-04

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 10 mL dispensers.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2019·2019-09-04

    Stryker Endotrac Push Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2019·2019-09-04

    Ad-Tech Spencer Probe Depth Electrodes Recalled for Incorrect Contact Count Labeling

    Ad-Tech Medical Instrument Corporation is recalling 18 Spencer Probe Depth Electrodes because two units labeled as 8-contact were actually 6-contact. No patient impact was reported.

    Product
    AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2019·2019-09-04

    Bausch & Lomb Recalls Laseredge 1.1mm Arrow Knife Due to Dull Edge

    Bausch & Lomb is recalling Laseredge 1.1mm Arrow Knives used in ophthalmic surgery because the knife edge may be dull.

    Product
    Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Triangle Blades Due to Seal Integrity

    Stryker GmbH is recalling 94 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2366-2019·2019-09-04

    Bausch & Lomb Recalls Laseredge Knives Due to Possible Dull Edge

    Bausch & Lomb is recalling specific Laseredge Knives used in ophthalmic surgery because they may have dull edges.

    Product
    Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 28 Endotrac ECTR Hook Blade kits because the sterile bag seal integrity may be compromised.

    Product
    Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2362-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled for Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
    Category
    Medical Device
    Distribution
    22 states
  • LowFDA (Drugs)·D-1841-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1840-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

    Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1839-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide

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