The Recall Desk

Archive

October 2015 recalls

479 recalls were announced in October 2015.

What the numbers show

Critical
22
Severe
130
High
212
Moderate
87
Low
28

Of the 479 recalls this month scored against our rubric, 5% are Critical, 27% are Severe.

201–300 of 479

  • ModerateFDA (Drugs)·D-0039-2016·2015-10-21

    Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0019-2016·2015-10-21

    QC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling QC Quality Choice Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2016·2015-10-21

    Synthes Screw Inserter Recalled for Incorrect Etched Graphics

    Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.

    Product
    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Variety Packs Due to Potential Mold

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce Variety Packs due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Variety Packs, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0021-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0016-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Potential Data Loss

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301C
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0030-2016·2015-10-21

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results

    Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0018-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Grape, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0036-2016·2015-10-21

    Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

    Product
    Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0016-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Banana, due to the potential presence of mold. The recall affects 34,573 cases distributed in the US and Canada.

    Product
    GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0122-2016·2015-10-21

    Alere Cholestech LDX Multianalyte Controls Recalled for Incorrect Ranges

    Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.

    Product
    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0010-2016·2015-10-21

    Shawnee Milling Recalls All Purpose Flour Due to Foreign Material

    Shawnee Milling Company is recalling specific lots of all-purpose flour due to the presence of foreign material. The recall covers products distributed in five states.

    Product
    Sysco 25 pound All Purpose Flour: Best By 07/22/2016; Always Save 5 pound All Purpose Flour: Best By 07/23/2016; Best Choice 5 pound All Purpose Flour: Best By 07/23/2016; Hy Top 5 pound All Purpose Flour: Best By 07/24/2016
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0011-2016·2015-10-21

    Shawnee Milling Company Recalls Self-Rising Flour Due to Foreign Material

    Shawnee Milling Company is recalling multiple brands of self-rising flour because of foreign material. The affected products were distributed in five states.

    Product
    Shawnee Milling Company Hotel And Restaurant Self Rising Climax Four Net 50 Lbs.; Always Save Self-Rising Flour Enriched Bleached Net Wt 5 LB (2.26kg) in waxed paper bag; Best Choice Flour Self-Rising Enriched Bleached Net Wt 5 LB (2.26 kg) in wax paper bag; HyTop Enriched Flour…
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0033-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

    Product
    Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2016·2015-10-21

    Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction

    Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.

    Product
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2016·2015-10-21

    Ohm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-303A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0015-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Mango, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Mango, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0014-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0014-2016·2015-10-21

    Actavis Recalls Metformin Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, because they failed dissolution specifications at the 8-hour timepoint.

    Product
    Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0019-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Organic Apple, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Organic Apple, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0022-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Berry Pear, due to the potential presence of mold. Consumers should check their pantries for affected lots.

    Product
    GoGo SQueeZ Applesauce, Berry Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0015-2016·2015-10-21

    Ferring Recalls Bravelle 75 IU Vials Due to Subpotent Drug

    Ferring Pharmaceuticals is recalling 32,341 vials of Bravelle 75 IU because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0022-2016·2015-10-21

    Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0035-2016·2015-10-21

    TopCare Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling TopCare Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0023-2016·2015-10-21

    CVS Loratadine Tablets Recalled for Out-of-Specification Assay Results

    CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0116-2016·2015-10-21

    Concentric Medical Recalls One Distal Access Catheter for Distribution Error

    Concentric Medical Inc is recalling one Distal Access Catheter that was intended for distribution in Korea but was found at a US location in Kentucky.

    Product
    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0026-2016·2015-10-21

    Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.

    Product
    Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0037-2016·2015-10-21

    Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0016-2016·2015-10-21

    Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination

    Tribute Pharmaceuticals is recalling specific lots of Fenofibric Acid Tablets because they may contain trace amounts of benzophenone from label varnish.

    Product
    Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0020-2016·2015-10-21

    Rite Aid Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.

    Product
    Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0017-2016·2015-10-21

    Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination

    Tribute Pharmaceuticals is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg because they may contain trace amounts of benzophenone from label varnish.

    Product
    Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0031-2016·2015-10-21

    Major Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.

    Product
    Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0021-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Assay Failure

    Ohm Laboratories is recalling specific batches of loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0038-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues

    Ohm Laboratories is recalling Wal-itin Loratadine Orally Disintegrating Tablets because they failed potency testing. The FDA classified this as a Class III recall.

    Product
    Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0034-2016·2015-10-21

    Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·128-2015·2015-10-20

    Taylor Farms Recalls Turkey Meatloaf Due to Undeclared Allergens

    Taylor Farms is recalling approximately 276 pounds of turkey meatloaf products because they contain undeclared eggs, soy, and wheat.

    Product
    Taylor Farms New Jersey, Inc. — Taylor Farms Recalls Turkey Meatloaf Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·15V682000·2015-10-20

    Volvo Recalls 2016 VN Trucks for Transmission Locking Hazard

    Volvo is recalling 2016 VN trucks because the manual transmission may lock or cause the vehicle to move unexpectedly, increasing crash risk.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16013·2015-10-20

    API Outdoors Recalls Climbing Tree Stands Due to Fall Hazard

    Global Manufacturing Company is recalling API Outdoors climbing tree stands because the cable assembly can release, posing a fall hazard.

    Product
    Climbing tree stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E085000·2015-10-20

    Cummins Westport ISL G Engine Recall for Turbocharger Oil Leak Risk

    Cummins is recalling Westport ISL G engines due to a turbocharger oil supply line that may leak, increasing the risk of fire near the exhaust manifold.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:OTHER FUEL TYPES:TURBO/SUPERCHARGER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16010·2015-10-20

    Turtle Beach Recalls XO FOUR Stealth Gaming Headsets Due to Mold Risk

    Turtle Beach is recalling about 59,500 XO FOUR Stealth gaming headsets because mold spores were found on the units, posing a risk of respiratory or other infections.

    Product
    Ear Force® XO FOUR Stealth gaming headset
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16012·2015-10-20

    Big Game Recalls Climbing Tree Stands Due to Fall Hazard

    Big Game is recalling about 12,200 climbing tree stands because the cable assembly can release, posing a fall hazard. One injury report has been received.

    Product
    Climbing tree stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V681000·2015-10-20

    Nissan and Infiniti Recall Vehicles Due to Passenger Air Bag Defect

    Nissan is recalling specific 2013-2015 models because a faulty sensor may prevent the passenger air bag from deploying in a crash.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, JX35, ALTIMA, SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V675000·2015-10-19

    Dodge Journey Recall: Water Ingress Disables ABS and ESC Systems

    Chrysler is recalling 2012-2015 Dodge Journey vehicles because water may enter the ABS module, disabling safety systems and increasing crash risk.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V674000·2015-10-19

    Mazda Recalls 1989-1998 Vehicles for Ignition Switch Fire Risk

    Mazda is recalling approximately 1.37 million vehicles from 1989-1998 because grease in the ignition switch may overheat and cause a fire. Owners should contact a dealer for a free replacement.

    Product
    MAZDA — MAZDA 323, 626, MX3, 929
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V673000·2015-10-19

    Chrysler Recalls Jeep Vehicles for Inadvertent Air Bag Deployment Risk

    Chrysler is recalling specific 2003 Jeep Liberty and 2004 Jeep Grand Cherokee vehicles because an electrical issue may cause air bags to deploy unexpectedly, increasing injury risk.

    Product
    JEEP — JEEP LIBERTY, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V676000·2015-10-19

    Chrysler Recalls 2015 Jeep Cherokee for Fire Risk

    Chrysler is recalling 2015 Jeep Cherokee vehicles because a misrouted air conditioning hose may contact the exhaust manifold, increasing the risk of a vehicle fire.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V670000·2015-10-19

    Utilimaster Walk-In Van Recall for Incorrect Tire Placard Cargo Capacity

    Spartan Motors USA is recalling 2014-2015 Utilimaster Walk-In Vans because the tire placard may display incorrect cargo capacity information, potentially leading to vehicle overload.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V672000·2015-10-19

    Volvo Recalls 2016 VN Trucks for Engine Stalling Risk

    Volvo is recalling 2016 VN trucks because a faulty engine control module may cause the engine to stall without warning, increasing crash risk.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·127-2015·2015-10-18

    Good Food Concepts Recalls Beef, Pork, and Poultry Products for HACCP and Labeling Issues

    Good Food Concepts is recalling approximately 12,566 pounds of beef, pork, and poultry products produced without a fully implemented HACCP plan and misbranded with undeclared sodium nitrite.

    Product
    Good Food Concepts, LLC — Good Food Concepts Recalls Beef, Pork, and Poultry Products Produced Without a Fully Implemented HACCP Plan, and Misbranded
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V669000·2015-10-16

    Starcraft RV Recalls 2016 Travel Trailers Due to Water Heater Wiring Defect

    Starcraft RV is recalling 247 model year 2016 Travel Star and Launch Ultra Lite travel trailers because improper water heater wiring may prevent the gas warning light from illuminating, increasing the risk of fire.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT TRAVEL STAR, LAUNCH ULTRA LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V662000·2015-10-16

    Mercedes-Benz Recalls 2015-2016 Models Due to Camshaft Weld Failure Risk

    Mercedes-Benz is recalling 857 vehicles due to potential camshaft weld failure that could cause engine damage and stalling, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250, SLK300, CLA250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V667000·2015-10-16

    Utilimaster Walk-In Van Brake Line Recall for 2012 Models

    Spartan Motors is recalling 2012 Utilimaster Walk-In Vans because a ramp may rub against a hydraulic brake line, potentially causing brake fluid loss and increased stopping distance.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V666000·2015-10-16

    GM Recalls 2015 Vehicles Due to Side Air Bag Inflator Rupture Risk

    General Motors is recalling specific 2015 Buick, Cadillac, Chevrolet, and GMC vehicles because side air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    CHEVROLET — CHEVROLET, BUICK, GMC EQUINOX, LACROSSE, TERRAIN, CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V664000·2015-10-16

    Winnebago and Itasca Motorhomes Recalled for Transmission Shift Cable Defect

    Winnebago is recalling 2015-2016 Brave, Sightseer, Vista, Adventurer, and Itasca models because they can shift out of park without brakes applied.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA SIGHTSEER, VISTA, BRAVE, ADVENTURER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V659000·2015-10-15

    Forest River Recalls 2016 Surveyor Travel Trailers Due to Fire Risk

    Forest River is recalling 2016 Surveyor travel trailers and fifth wheels because an incorrectly installed power supply wire may cause a fire.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V661000·2015-10-15

    Chrysler Recalls 2015-2016 Ram 1500 Trucks for Rear Axle Defect

    Chrysler is recalling 2015-2016 Ram 1500 trucks because rear axles may have been incorrectly heat treated, potentially causing a fracture and wheel separation.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V658000·2015-10-15

    Airstream Recalls 2015-2016 Interstate Models Due to Wiring Fire Risk

    Airstream is recalling 2015-2016 Interstate Grand Tour and Lounge Extended vehicles because improperly tightened electrical wiring may overheat and cause a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE LOUNGE EXT, INTERSTATE GRAND TOUR EXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16008·2015-10-15

    Horizon Hobby Recalls E-flite Battery Chargers Due to Fire Hazard

    Horizon Hobby is recalling E-flite Ultra Micro-4 AC/DC Battery Chargers because they can overheat and cause fires. No injuries have been reported.

    Product
    E-flite Ultra Micro-4 AC/DC Battery Chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V660000·2015-10-15

    BMW Recalls 2002-2005 MINI Cooper Vehicles for Steering Assist Loss

    BMW is recalling 2002-2005 MINI Cooper and Cooper S vehicles because the power steering system may fail, requiring extra effort to steer and increasing crash risk.

    Product
    MINI — MINI COOPER, COOPER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0059-2016·2015-10-14

    FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0111-2016·2015-10-14

    DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints

    DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.

    Product
    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with…
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-0082-2016·2015-10-14

    FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0033-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0074-2016·2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·15V652000·2015-10-14

    Mercedes-Benz Recalls S63 AMG Sedans and Coupes for Engine Stall Risk

    Mercedes-Benz is recalling 2014-2016 S63 AMG vehicles because a software error may cause the engine to stall and fail to restart, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63 4MATIC, AMG S63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2016·2015-10-14

    FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0007-2016·2015-10-14

    Merck Recalls Vytorin Tablets Due to Foreign Tablet Presence

    Merck Sharp & Dohme is recalling specific bottles of Vytorin 10 mg/20 mg tablets because they contain 10 mg/40 mg tablets. The recall affects distribution in Kentucky, Mississippi, and Ohio.

    Product
    Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0092-2016·2015-10-14

    FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0006-2016·2015-10-14

    Sermorelin Injection Recalled Due to Sterility Assurance Concerns

    DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder because an FDA inspection found it was not compounded in an appropriate area, potentially compromising sterility.

    Product
    Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0078-2016·2015-10-14

    FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0052-2016·2015-10-14

    Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0070-2016·2015-10-14

    FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0068-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.

    Product
    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0112-2016·2015-10-14

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.

    Product
    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0102-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Titanium Rib Surgical Kits

    Resource Optimization & Innovation LLC is recalling 62 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0108-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2016·2015-10-14

    FDA Recalls 114 Sterile Head and Neck Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 114 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0067-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Neurosurgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 181 neurosurgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0098-2016·2015-10-14

    Resource Optimization & Innovation Recalls Pediatric Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 158 pediatric surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0058-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 125 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0069-2016·2015-10-14

    FDA Recalls VP Shunt Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 200 VP Shunt surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0091-2016·2015-10-14

    FDA Recalls 510 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 510 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0043-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile AV Access Surgical Kits

    Resource Optimization & Innovation LLC is recalling 192 sterile AV Access surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0071-2016·2015-10-14

    Resource Optimization & Innovation Recalls 158 Sterile Titanium Rib Surgical Kits

    Resource Optimization & Innovation LLC is recalling 158 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0037-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 832 sterile shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states

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