The Recall Desk

Archive

May 2016 recalls

603 recalls were announced in May 2016.

What the numbers show

Critical
27
Severe
108
High
210
Moderate
211
Low
47

Of the 603 recalls this month scored against our rubric, 4% are Critical, 18% are Severe.

501–600 of 603

  • SevereFDA (Food)·F-1240-2016·2016-05-04

    Nature's Eats Hill Country Ramblin' Recalled for Potential Salmonella Contamination

    Texas Star Nut and Food Co. is recalling Nature's Eats Hill Country Ramblin' due to potential Salmonella contamination. The product was distributed in Texas and Louisiana.

    Product
    Nature's Eats Hill Country Ramblin' NET WT 15 OZ (425g) packaged in clear cello bag
    Category
    Food
    Distribution
    2 states
  • SevereUSDA FSIS·035-2016·2016-05-04

    Michael Angelo's Vegetable Lasagna Recalled for Undeclared Allergens

    Michael Angelo's is recalling 1,575 pounds of vegetable lasagna due to misbranding and undeclared turkey and eggs.

    Product
    Michael Angelo's Gourmet Foods Inc. — Michael Angelo's Gourmet Foods, Inc. Recalls Vegetable Lasagna Products Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1257-2016·2016-05-04

    Dietz & Watson Roasted Veggie Tortilla Wrap Recalled for Glass Fragments

    Flying Food Group LLC is recalling Dietz & Watson Roasted Veggie White Tortilla Wraps due to potential glass fragments from raw materials.

    Product
    Dietz & Watson Brand Roasted Veggie White Tortilla Wrap - 9.68 oz wrapped in plastic in a open paper box
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1250-2016·2016-05-04

    Tarry Medical Recalls DandleLION Kisses Due to Microbial Contamination

    Tarry Medical Products is recalling DandleLION Kisses sterile sucrose solution due to microbial contamination. The product is distributed in nine states.

    Product
    DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Food)·F-1249-2016·2016-05-04

    Roland Fire Roasted Red Pepper Strips Recalled for Glass Fragments

    Roland Foods is recalling Fire Roasted Red Pepper Strips due to the possible presence of glass fragments in specific lots.

    Product
    Roland (R) Fire Roasted Red Pepper Strips, NET WT. 5 LB. 8 OZ. (2.5 kg), UPC 10041224456287 (carton) and 04122456280 (can), PRODUCT OF PERU -- Packed Exclusively For: ROLAND FOODS, LLC, New York, NY 10070
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1241-2016·2016-05-04

    Nature's Eats Austin's Nutty All-Terrain Recalled for Salmonella Risk

    Texas Star Nut and Food Co. is recalling 283 cases of Nature's Eats Austin's Nutty All-Terrain due to potential Salmonella contamination.

    Product
    Nature's Eats Austin's Nutty All-Terrain NET WT 12 OZ (340g) packaged in clear cello bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1239-2016·2016-05-04

    Texas Star Nut and Food Co. Recalls Survivor Mix for Salmonella Risk

    Texas Star Nut and Food Co. is recalling three brands of survivor mix due to potential Salmonella contamination. The products were distributed in Texas and Louisiana.

    Product
    Fresh Choices Survivor Mix NET WT 4.75 OZ (135g) packaged in clear cello bag and Nature's Eats Survivor Mix NET WT 10 OZ (284g) packaged in clear cello bag and Southern Grove Survival Trail Mix NET WT 10 OZ (283g) packaged in clear cello bag
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V270000·2016-05-04

    Newmar Recalls 2015-2016 Ventana Models Due to Front Sway Bar Defect

    Newmar is recalling 2015-2016 Ventana and Ventana LE vehicles because front sway bar brackets may not fit properly, risking bolt failure and loss of vehicle control.

    Product
    NEWMAR — NEWMAR VENTANA LE, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V271000·2016-05-04

    Kaufman Trailers Recalls 2015-2016 Flatbed and Wedge Car Haulers

    Kaufman is recalling 2015-2016 Flatbed Equipment and Wedge Car Hauler trailers because axle hanger lock nuts may loosen, potentially causing the axle to detach and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN WEDGE CAR HAULER, FLATBED EQUIPMENT TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1126-2016·2016-05-04

    Health Matters America Recalls Sprouted Flax Seed Powder for Salmonella Risk

    Health Matters America is recalling Organic Traditions Sprouted Flax Seed Powder due to potential Salmonella contamination. Consumers should stop using the product.

    Product
    Organic traditions SPROUTED FLAX SEED POWDER, NET WT. 8 oz/227g, UPC 854260006261 --- The product is packed in a sealed flexible plastic bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1238-2016·2016-05-04

    Texas Star Nut Pistachios Recalled for Potential Salmonella Contamination

    Texas Star Nut and Food Co. is recalling specific lots of pistachios due to potential Salmonella contamination. The products were distributed in Texas and Louisiana.

    Product
    Nature's Eats Natural Pistachios NET WT 8 OZ (227g) packaged in clear cello bag and Bulk RAW PISTACHIO - 25 LBS and Bulk RAW PISTACHIO - 5 LBS packaged in corrugated box
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1583-2016·2016-05-04

    Mako Surgical Recalls RESTORIS PST RIO Offset Shell Impactor

    Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.

    Product
    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2016·2016-05-04

    Siemens SOMATOM Force CT Systems Recalled for Image Artifacts

    Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.

    Product
    SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1127-2016·2016-05-04

    Organic Traditions Sprouted Chia & Flax Seed Powder Recalled for Salmonella Risk

    Health Matters America is recalling Organic Traditions Sprouted Chia & Flax Seed Powder due to potential Salmonella contamination.

    Product
    Organic traditions SPROUTED CHIA & FLAX SEED POWDER, NET WT. 8 oz./227g (UPC barcode 854260006216), and NET WT. 16oz./454g bag (UPC barcode 85426000547) --- The product is packed in a sealed flexible plastic bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1069-2016·2016-05-04

    WelleCo Super Elixir Greens Recalled for Potential Salmonella Contamination

    Welle Pty Ltd is recalling WelleCo Super Elixir Alkalising Greens pouches due to potential Salmonella contamination. The recall affects 150g and 300g pouches sold online in the U.S.

    Product
    The Super Elixir By WelleCo Australia Alkalising Greens 150g/5.3 oz net, 300g/10.6 oz net Fine Powder welleco.com
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V268000·2016-05-04

    Volvo Recalls 2016 XC90 Vehicles Due to Sunroof Switch Defect

    Volvo is recalling 2016 XC90 vehicles because the sunroof switch may be unintentionally pressed, causing the panel to close and increasing the risk of occupant injury.

    Product
    VOLVO — VOLVO XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1129-2016·2016-05-04

    NOW Foods Andrographis Extract Recalled for Undeclared Soy Lecithin

    NOW Foods is recalling Andrographis extract 400 mg capsules due to undeclared soy lecithin. The product was distributed to 499 consignees in the US and one in Japan.

    Product
    Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Devices)·Z-1554-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

    Product
    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2016·2016-05-04

    Research Instruments Recalls Integra 3 Micromanipulators Due to Faulty Power Cable

    Research Instruments Ltd is recalling 380 Integra 3 micromanipulators because they were fitted with a potentially faulty power supply cable.

    Product
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1243-2016·2016-05-04

    Texas Star Nut and Food Co. Recalls Nature's Eats Raw Nuts for Salmonella

    Texas Star Nut and Food Co. is recalling Nature's Eats Simply Go Raw nuts due to potential Salmonella contamination. The product was distributed in Texas and Louisiana.

    Product
    Nature's Eats Simply Go Raw NET WT 8 OZ (227g) packaged in clear cello bag
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1248-2016·2016-05-04

    Duncan Hines Swiss Chocolate Cake Mix Recalled for Undeclared Milk

    Pinnacle Foods is recalling Duncan Hines Swiss Chocolate Cake Mix because a natural flavoring containing milk was used, but the product was labeled as non-milk.

    Product
    Duncan Hines Moist Deluxe Swiss Chocolate (Chocolate Suizo) Cake Mix, Net Wt. 16.5 oz. (1 LB 5 oz.) 468 g, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 309748 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1130-2016·2016-05-04

    NOW Foods Recalls Elderberry Supplements Due to Undeclared Soy Lecithin

    NOW Foods is recalling 57 bottles of Elderberry 500 mg capsules because they contain undeclared soy lecithin, a common allergen.

    Product
    Elderberry 500 mg packaged in a white and orange bottle containing 60 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-1259-2016·2016-05-04

    Shaw's Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Italian Subs due to a potential risk of glass fragments from raw materials.

    Product
    Shaw's Brand Market Fresh Shaw Market Fresh Italian Sub, 8.3 oz. wrapped in plastic in open paper box container
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1255-2016·2016-05-04

    Dietz & Watson Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Dietz & Watson Italian Sub 7.3 oz bags due to potential glass fragments from a supplier's raw material recall.

    Product
    Dietz & Watson Brand Italian Sub 7.3 oz bag
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1247-2016·2016-05-04

    Duncan Hines Swiss Chocolate Cake Mix Recalled for Undeclared Milk

    Pinnacle Foods is recalling Duncan Hines Swiss Chocolate Cake Mix because a natural flavoring containing milk was used, but the product was labeled as non-milk.

    Product
    Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 41120 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2016·2016-05-04

    GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect

    GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and ventilation.

    Product
    GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1568-2016·2016-05-04

    Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk

    Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion during use.

    Product
    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1133-2016·2016-05-04

    NOW Foods Recalls Cranberry Extract for Undeclared Soy Lecithin

    NOW Foods is recalling 3 bottles of cranberry extract capsules due to undeclared soy lecithin. The product was distributed to 499 consignees in the US and one in Japan.

    Product
    Cranberry extract packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-1258-2016·2016-05-04

    Shaw's Eggplant and Cheese Wrap Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Eggplant & Cheese Wraps due to a potential for glass fragments from a supplier raw material recall.

    Product
    Shaw's Brand Market Fresh Eggplant & Cheese Wrap, 10.0 oz packaged in plastic inside a paper open box
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1256-2016·2016-05-04

    Shaw's Turkey Sandwiches Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat sandwiches due to potential glass fragments from raw materials.

    Product
    Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat, 5.4 oz. packaged in a wedge container
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1132-2016·2016-05-04

    NOW Foods Recalls Goldenseal Root Supplements Due to Undeclared Soy Lecithin

    NOW Foods is recalling Goldenseal Root 500 mg capsules because they contain undeclared soy lecithin, a common allergen.

    Product
    Goldenseal Root 500 mg packaged in a white and orange bottle containing 100 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighUSDA FSIS·034-2016·2016-05-04

    Trader Joe's Broccoli Slaw and Kale Salad Recalled for Listeria Risk

    Ghiringhelli Specialty Foods is recalling Trader Joe's Broccoli Slaw & Kale Salad with White Chicken Meat due to possible Listeria monocytogenes contamination.

    Product
    Ghiringhelli Brothers — Ghiringhelli Specialty Foods Firm Recalls Trader Joe's Broccoli Slaw & Kale Salad With White Meat Chicken Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1131-2016·2016-05-04

    NOW Foods Recalls Gingko Biloba Supplements Due to Undeclared Soy

    NOW Foods is recalling Gingko Biloba 60mg capsules because they contain undeclared soy lecithin. Consumers should stop using the product and return it to the place of purchase.

    Product
    Gingko Biloba 60mg packaged in a white and orange bottle containing 120 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-1252-2016·2016-05-04

    Fresh Express Baby Spinach Recalled for Undeclared Almond Allergen

    Fresh Express is recalling 12-ounce bags of Family Size Baby Spinach due to an undeclared almond allergen. The product was distributed in Connecticut, Florida, and Maryland.

    Product
    Fresh Express, Family Size Baby Spinach, Net Wt. 12oz in clear flexible plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1563-2016·2016-05-04

    3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error

    3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1573-2016·2016-05-04

    Philips NeuViz 16 CT Scanner Recall for Patient Data Error

    Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.

    Product
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1559-2016·2016-05-04

    Becton Dickinson Recalls Listeria-Contaminated Trypticase Soy Agar Plates

    Becton Dickinson is recalling Trypticase Soy Agar and MacConkey II Agar plates contaminated with Listeria monocytogenes. The non-sterile media are used for growing and detecting bacteria.

    Product
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1029-2016·2016-05-04

    Starbucks Cheese and Fruit Bistro Box Recalled for Undeclared Cashews

    Gretchen's Shoebox Express is recalling Starbucks Cheese & Fruit Bistro Boxes because they may contain undeclared cashews.

    Product
    Cheese & Fruit Bistro Box (Item #11015085), Starbucks brand. Product is packaged in plastic clamshell, net wt. 5.3 oz. The UPC is 7 62111 88146 5.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1254-2016·2016-05-04

    Dunkin Donuts Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Dunkin Donuts Brand Italian Subs due to a potential for glass fragments from a supplier raw material recall.

    Product
    Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in Bag, Clear View
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1585-2016·2016-05-04

    Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

    Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

    Product
    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiogr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1268-2016·2016-05-04

    Bliss Bros Dairy Recalls Coffee Ice Cream for Air Space Failures

    Bliss Bros Dairy is recalling Cresent Ridge Coffee Ice Cream because the product failed to meet air space specifications.

    Product
    Cresent Ridge Coffee Ice Cream 3 gallon Product Code: 36102
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1569-2016·2016-05-04

    Ortho-Clinical enGen Laboratory Automation System Recalled for Electrical Cable Hazard

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems because an electrical cable may loosen and cause sample fluid to splash.

    Product
    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Food)·F-1266-2016·2016-05-04

    Bliss Bros Dairy Recalls Cresent Ridge Ice Cream for Air Space Issues

    Bliss Bros Dairy is recalling Cresent Ridge ChocChp CookiDgh WRAP Ice Cream because the product failed to meet air space specifications.

    Product
    Cresent Ridge ChocChp CookiDgh WRAP Ice Cream 48oz Product Code: 35403
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1566-2016·2016-05-04

    Stryker PneumoSure Insufflators Recalled for Flow Rate Drop

    Stryker Endoscopy is recalling PneumoSure insufflators because the flow rate drops to zero when connected to a house gas source, suspending insufflation.

    Product
    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2016·2016-05-04

    Corin Trinity Acetabular System Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular System devices due to potential abrasion of sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular System Product Usage - Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1557-2016·2016-05-04

    Philips Visicu eCareCoordinator Software Error Recall

    Philips Visicu is recalling eCareCoordinator software due to an error that prevents patient task reminders from being generated.

    Product
    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1556-2016·2016-05-04

    Stryker Recalls Spirit One Hospital Beds Due to Inaccurate Scale Systems

    Stryker is recalling 143 Spirit One A-C Powered Hospital Beds because their scale systems are inaccurate. The beds were distributed in 19 US states, Canada, and the UK.

    Product
    Spirit One A-C Powered Hospital Bed
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-1261-2016·2016-05-04

    Family Gourmet Brown Rice Recalled Due to Live Insects

    Family Dollar is recalling Family Gourmet Natural Whole Grain Brown Rice because live insects were found in unopened bags.

    Product
    Family Gourmet Natural Whole Grain Brown Rice, 32 oz. (2 lb.) plastic bag (SKU: 1230394)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2016·2016-05-04

    Corin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.

    Product
    Trinity Acetabular Shell Product Usage Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1564-2016·2016-05-04

    Hansen Medical Recalls Magellan Robotic Catheter Accessory Kits

    Hansen Medical is recalling eight Magellan Robotic Catheter Accessory Kits because one batch was radiated below the required dose.

    Product
    Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2016·2016-05-04

    Siemens ACUSON X700 Ultrasound System Recalled for Software Lockup

    Siemens is recalling four ACUSON X700 ultrasound systems due to a software error that causes the system to lock up, requiring a reboot to recover operation.

    Product
    ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging syst
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1527-2016·2016-05-04

    Corin Trinity Acetabular Shell Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shell devices used in total hip replacements due to a potential for abrasion of the sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular Shell Product Usage: Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1260-2016·2016-05-04

    Family Gourmet White Rice Recalled Due to Live Insects

    Family Dollar is recalling Family Gourmet Long Grain Enriched White Rice because live insects were found inside unopened bags.

    Product
    Family Gourmet Long Grain Enriched White Rice, 32 oz. (2 lb.) plastic bag (SKU: 1218898)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2016·2016-05-04

    Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure

    Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.

    Product
    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1560-2016·2016-05-04

    Toshiba Recalls Aquilion Lightning CT System iStation Cover

    Toshiba American Medical Systems is recalling the Aquilion Lightning CT System iStation cover because it may fall off the gantry.

    Product
    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstr
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1576-2016·2016-05-04

    Drew Scientific Recalls Drew3-PAC Reagent Packs Due to Platelet Background Issues

    Jas Diagnostics/Drew Scientific is recalling Drew3-PAC reagent packs because they may cause elevated platelet background during routine analyzer checks.

    Product
    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Food)·F-1280-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Cake Batter Ice Cream

    Bliss Bros Dairy is recalling Emack & Bolios Cake Batter Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Cake Batter Ice Cream, 3gal Product Code: 36266
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1565-2016·2016-05-04

    Baxter APD Cycler Recall for Incomplete Clinician Guide Instructions

    Baxter Healthcare is recalling 10 automated peritoneal dialysis cyclers because the clinician guide lacks instructions for priming the patient line.

    Product
    Automated peritoneal dialysis (APD) cycler
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1567-2016·2016-05-04

    Boston Scientific Recalls Mislabeled Ultraflex Tracheobronchial Stents

    Boston Scientific is recalling four Ultraflex Tracheobronchial stents because 10mm diameter units were mislabeled as 12mm diameter.

    Product
    Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1246-2016·2016-05-04

    Bissinger's Milk Chocolate Eggs Recalled for Mislabeling Artificial Vanillin as Vanilla

    Karl Bissinger, LLC is recalling Bissinger's Milk Chocolate Eggs because the product contains artificial vanillin but is labeled as containing vanilla.

    Product
    Bissinger's Milk Chocolate Eggs packaged in 6.5 oz (UPC 846107009382) Item: #11108 or 1 lb. (UPC 846107003458) Item: # 111049 plastic bags. Bissinger's Handcrafted Chocolatier, St. Louis, MO.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1125-2016·2016-05-04

    Liquid Coffee Inc Recalls Concentrated Coffee Due to Elevated pH Levels

    Liquid Coffee Inc is recalling 642 gallons of concentrated coffee because the pH level was elevated above 4.6. The product was distributed nationwide to specific states.

    Product
    Concentrated coffee packed in 1/2 gallon or 1 gallon hermetically sealed Scholle or Liquibag.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2016·2016-05-04

    Mindray Panorama Patient Monitoring Network Recalled for Date Reversion

    Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.

    Product
    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2016·2016-05-04

    BD Trucount Absolute Counting Tubes Recalled for Lot Mixing

    Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.

    Product
    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flo
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-1265-2016·2016-05-04

    Bliss Bros Dairy Recalls Yogurt for Air Space Specification Failure

    Bliss Bros Dairy, Inc. is recalling 40 cases of Bliss Mix 5% Yog 5gal FRESH because the product failed to meet air space specifications.

    Product
    Bliss Mix 5% Yog 5gal FRESH Product Code: 79801
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1574-2016·2016-05-04

    Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment

    Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.

    Product
    5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-1269-2016·2016-05-04

    Bliss Bros Dairy Recalls Cresent Ridge Choc Chip Cookie Dough

    Bliss Bros Dairy is recalling 5 units of Cresent Ridge Choc Chip Cookie Dough because the product failed to meet air space specifications.

    Product
    Cresent Ridge Choc Chip Cookie Dough 48oz Product Code: 35418
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1275-2016·2016-05-04

    Emack & Bolios Ice Cream Recalled for Air Space Specification Failures

    Bliss Bros Dairy is recalling Emack & Bolios Caramel Moose Prints Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Caramel Moose Prints Ice Cream, 3gal Product Code: 36285
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-0834-2016·2016-05-04

    SKY Aspirin Chewable Tablets Recalled for Incorrect Outer Carton Labeling

    McKesson Packaging Services is recalling SKY Aspirin Chewable Tablets because the outer cartons were incorrectly labeled. The recall addresses a labeling mix-up.

    Product
    SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1581-2016·2016-05-04

    LED Technologies Recalls reVive Light Therapy Devices Due to Power Supply Error

    LED Technologies, LLC is recalling 32 units of the reVive Light Therapy Pain Relief Device because an incorrect power supply was included, rendering the devices inoperable.

    Product
    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pai
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1277-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Ice Cream for Air Space Issues

    Bliss Bros Dairy is recalling 50 units of Emack & Bolios Stoney's Dream Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Stoney's Dream Ice Cream, 3gal Product Code: 36276
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1281-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Space Cake Ice Cream

    Bliss Bros Dairy is recalling Emack & Bolios Space Cake Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Space Cake Ice Cream, 3gal Product Code: 36273
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1279-2016·2016-05-04

    Bliss Bros Dairy Recalls Pistachio Ice Cream for Packaging Defect

    Bliss Bros Dairy is recalling Emack & Bolios Pistachio Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Pistachio Ice Cream, 3gal Product Code: 36262
    Category
    Food
    Distribution
    7 states
  • LowFDA (Devices)·Z-1582-2016·2016-05-04

    Teleflex Pleur-evac Chest Drainage System Recalled for Missing Tyvek Bag Label

    Teleflex Medical is recalling Pleur-evac Chest Drainage Systems because the Tyvek bag label is missing, preventing identification of material code, lot number, and expiration date.

    Product
    Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1253-2016·2016-05-04

    Suan's Scotch Bonnet Pepper Relish Recalled for Swollen or Leaking Lids

    S & S Foods, Inc. is recalling 262 jars of Suan's Scotch Bonnet Pepper Relish in Oklahoma due to reports of swollen or leaking lids.

    Product
    Suan's Scotch Bonnet Pepper Relish 9.8 oz. packaged in a glass jar with a metal lid.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1273-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Ice Cream for Air Space Defect

    Bliss Bros Dairy is recalling Emack & Bolios Serious Choc Addiction Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Serious Choc Addiction Ice Cream 3gal Product Code: 36271
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1282-2016·2016-05-04

    Bliss Bros Dairy Recalls Newport Creamery Butter Crunch Ice Cream

    Bliss Bros Dairy, Inc. is recalling Newport Creamery Butter Crunch Ice Cream because the product failed to meet air space specifications.

    Product
    Newport Creamery Butter Crunch Ice Cream, 3Gal Product Code: 35108
    Category
    Food
    Distribution
    7 states
  • LowFDA (Food)·F-1276-2016·2016-05-04

    Bliss Bros Dairy Recalls Emack & Bolios Grasshopper Ice Cream

    Bliss Bros Dairy is recalling 240 units of Emack & Bolios Grasshopper Ice Cream because the product failed to meet air space specifications.

    Product
    Emack & Bolios Grasshopper Ice Cream 3gal Product Code: 36272
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·16V265000·2016-05-03

    Blue Bird Recalls 2017 Transit Buses Due to Seat Separation Risk

    Blue Bird is recalling specific 2017 Vision and All American transit buses because child seats may separate from the base frame due to bolt failure.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V267000·2016-05-03

    Forest River Recalls 2007-2014 Solera and Coachmen Prism RVs

    Forest River is recalling 2007-2014 Solera and Coachmen Prism vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN SOLERA, PRISM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16155·2016-05-03

    Cascade Designs Recalls Avalanche Rescue Probes Due to Suffocation Risk

    Cascade Designs is recalling Striker 320 and 240 avalanche rescue probes because a lock button failure may prevent the probe from extending, posing a suffocation hazard.

    Product
    Avalanche rescue probes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V266000·2016-05-03

    Adkins Recalls 2013-2016 Dominator Trucks Due to Crane Cover Defect

    Adkins is recalling 2013-2016 Dominator trucks equipped with specific IMT cranes because the valve bank cover may crack and fall off, creating a road hazard.

    Product
    ADKINS — ADKINS DOMINATOR II, DOMINATOR I, DOMINATOR-PROPANE, DOMINATOR III
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.