The Recall Desk

Archive

December 2015 recalls

614 recalls were announced in December 2015.

What the numbers show

Critical
17
Severe
215
High
208
Moderate
133
Low
41

Of the 614 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

101–200 of 614

  • LowFDA (Devices)·Z-0501-2016·2015-12-30

    Ameditech Benzodiazepine Drug Test Recall for Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet drug tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    EDI BZO Uncut Sheet - Cup*, Item No. 160170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0544-2016·2015-12-30

    Philips Brilliance 64 CT System Recalled for Perfusion Software Issue

    Philips is recalling 30 Brilliance 64 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0502-2016·2015-12-30

    Ameditech iCup DX 10 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 10 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0527-2016·2015-12-30

    Ameditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0487-2016·2015-12-30

    Ameditech 11 Panel Card Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 50 kits of the 11 Panel Card (OPI 300) w/Adult because the tests showed reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0505-2016·2015-12-30

    Ameditech iCup DX 6 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 6 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0495-2016·2015-12-30

    Ameditech DrugSmart 12 Test Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart 12 Test Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0539-2016·2015-12-30

    Ameditech ProScreen Cup CLIA Drug Test Recall for Reduced Reactivity

    Ameditech is recalling ProScreen Cup CLIA drug tests because they may show reduced reactivity for specific benzodiazepine compounds.

    Product
    ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Due to pH Specification Failure

    Oasis Medical, Inc. is recalling HPMC Visoelastic syringes because the pH of the affected lots may not meet specifications at expiry.

    Product
    HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0524-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Due to Potential pH Specification Failure

    Oasis Medical is recalling HPMC Visoelastic syringes because the pH may not meet specifications at expiry. The recall covers 14,852 units distributed nationwide and internationally.

    Product
    HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0503-2016·2015-12-30

    Ameditech iCup DX 11 Panel Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling iCup DX 11 Panel tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0519-2016·2015-12-30

    Ameditech ProScreen 10 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0540-2016·2015-12-30

    Ameditech RealityCHECK Tilt Cup Benzodiazepine Test Recall

    Ameditech is recalling 80 kits of RealityCHECK Tilt Cup 12 Panel + Adult tests due to reduced reactivity for two benzodiazepine compounds.

    Product
    RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0457-2016·2015-12-30

    BC Group International Recalls Defibrillator and Pacer Analyzer Units

    BC Group International is recalling five DA-2006P Defibrillator / Pacer Analyzer units because reversed wires cause inverted waveforms.

    Product
    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0541-2016·2015-12-30

    Ameditech 6 Drug Cassette Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 300 kits of the Thermo Fisher 6 Drug Cassette because the tests may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2016·2015-12-30

    Philips Brilliance iCT SP CT System Software Feature Recall

    Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT SP Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0523-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Topical Due to pH Specification Failure

    Oasis Medical, Inc. is recalling HPMC Visoelastic Topical products because the pH may not meet specifications at expiry.

    Product
    HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0489-2016·2015-12-30

    Ameditech Drugs of Abuse Tests Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 3,603 kits of 6 Panel Cup Body and Lid w/Adult (AU) because they show reduced reactivity for two specific benzodiazepine compounds.

    Product
    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0504-2016·2015-12-30

    Ameditech iCup DX 12 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 12 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V883000·2015-12-29

    Micro Bird Recalls 2014-2016 School Buses for Loose Wheel Bolts

    Micro Bird is recalling 464 school buses because a camber caster kit bolt may be insufficiently torqued, posing a risk of vehicle misalignment and loss of control.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V884000·2015-12-29

    Micro Bird Recalls Transit Buses Due to Loose Wheel Bolt

    Micro Bird is recalling 2014-2016 G5 and MB II transit buses because a wheel bolt may be insufficiently torqued, posing a risk of vehicle misalignment and loss of control.

    Product
    MICRO BIRD — MICRO BIRD MB II TRANSIT BUS, G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V881000·2015-12-28

    Ferrari Recalls 2016 488 GTB Vehicles for Fuel Line Fire Risk

    Ferrari is recalling 119 model year 2016 488 GTB vehicles because a fuel line connection may leak vapor, increasing fire risk.

    Product
    FERRARI — FERRARI 488 GTB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V880000·2015-12-28

    Tiffin Motorhomes Recall 2007-2015 Models Due to Unstable Entry Steps

    Tiffin is recalling 2007-2015 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    TIFFIN — TIFFIN ALLEGRO, ALLEGRO BAY, BAY, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0292-2016·2015-12-23

    Whole Foods Recalls Curry Chicken Salad Due to Listeria Contamination

    Whole Foods Market Group Inc. is recalling Curry Chicken Salad CC sold by weight because it is contaminated with Listeria monocytogenes. The product was distributed in seven northeastern states.

    Product
    Curry Chicken Salad CC, sold by weight UPC 261068
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0411-2016·2015-12-23

    Tristar Recalls Golden Raisins for Undeclared Sulfites

    Tristar Food Wholesale is recalling Heng Cheong Loong Golden Raisins due to undeclared sulfites, posing a risk to sensitive individuals.

    Product
    Heng Cheong Loong Co., Net Wt: 10 oz. (5g), Plastic Bag, Product of U.S.A, UPC 6-930481-211418
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Devices)·Z-0360-2016·2015-12-23

    Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure

    Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.

    Product
    Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Food)·F-0291-2016·2015-12-23

    Whole Foods Recalls Curry Chicken Salad Wraps Due to Listeria

    Whole Foods Market is recalling Single Curry Chicken Salad Wraps in the Northeast due to Listeria monocytogenes contamination.

    Product
    Single Curry Chicken Salad Wrap, Made Right Here, 7oz UPC 263126
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0297-2016·2015-12-23

    Whole Foods Recalls Classic Deli Pasta Salad Due to Listeria

    Whole Foods Market is recalling Classic Deli Pasta Salad because it is contaminated with Listeria monocytogenes. The product was sold in the Northeast.

    Product
    Classic Deli Pasta Salad, 6oz UPC 0 36406 30001 7
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0417-2016·2015-12-23

    Ashdon Farms Honey Mustard Mix Recalled for Missing Milk Allergen Labeling

    A. L. Schutzman Company, Inc. is recalling Ashdon Farms Honey Mustard Mix because the packaging lists whey but fails to declare milk in the 'Contains' statement.

    Product
    Honey Mustard Mix sold under the following brand: Ashdon Farms, Net Wt. 8 oz. (227 g), UPC 79113-41184
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0290-2016·2015-12-23

    Whole Foods Recalls Curry Chicken Salad Wrap Due to Listeria

    Whole Foods Market is recalling Curry Chicken Salad Wraps in the Northeast due to Listeria monocytogenes contamination.

    Product
    Curry Chicken Salad Wrap, Made Right Here, sold by weight, 12oz UPC 263144 UPC Code : 285551
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0415-2016·2015-12-23

    Zenobia Recalls Flax Seed Meal Due to Possible Salmonella Presence

    Zenobia Co. is recalling My Spice Sage Ground Flax Seed Meal due to the possible presence of Salmonella. The product was sold nationwide via the internet.

    Product
    My Spice Sage Ground Flax Seed Meal under the following labels: 1) NET WT 4 oz. (113g) UPC# 00575004, 2) NET WT 16 oz. (454g) UPC# 00575016, 3) NET WT 50 pounds UPC# 00575111.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0294-2016·2015-12-23

    Whole Foods Recalls Curry Chicken Salad Rollups Due to Listeria

    Whole Foods Market Group Inc. is recalling Curry Chicken Salad Rollups contaminated with Listeria monocytogenes. The product was sold in the Northeast and Mid-Atlantic regions.

    Product
    Curry Chicken Salad Rollup, 7oz UPC 265325
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0296-2016·2015-12-23

    Whole Foods Recalls FP Pasta Salad Classic Deli Due to Listeria

    Whole Foods Market Group Inc. is recalling FP Pasta Salad Classic Deli sold by weight because it is contaminated with Listeria monocytogenes.

    Product
    FP Pasta Salad Classic Deli, sold by weight UPC 270742
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·15V878000·2015-12-23

    2015 Jeep Compass and Patriot Recalled for Power Steering Hose Defect

    Chrysler is recalling 2015 Jeep Compass and Patriot vehicles because a power steering hose clamp may be installed incorrectly, increasing the risk of a fire.

    Product
    JEEP — JEEP COMPASS, PATRIOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0394-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure

    Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0298-2016·2015-12-23

    Whole Foods Recalls Classic Deli Pasta Salad Due to Listeria

    Whole Foods Market Group Inc. is recalling Classic Deli Pasta Salad because it is contaminated with Listeria monocytogenes.

    Product
    Classic Deli Pasta Salad, 14 oz UPC 0 36406 30264 6
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0393-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure

    Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0406-2016·2015-12-23

    Kerry Foods Recalls Pink Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Pink Sanding Sugar because it may contain metal. The product was distributed to 19 states.

    Product
    Sprinkle King, Pink Sanding Sugar,QPIN413.L32, UPC:766818312000/ 10766818312007, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Food)·F-0418-2016·2015-12-23

    Bruce Foods Recalls Del Pasado Green Chiles Due to Metal Contamination

    Bruce Foods Corporation is voluntarily recalling 816 cases of Del Pasado Dice Green Chiles because the product may contain metal.

    Product
    Del Pasado Dice Green Chiles 100% Fire Roasted and Peeled NET WT. 6 LB 3 OZ (2.81 kg) packaged in #10 steel cans
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0412-2016·2015-12-23

    Gorgeous Memory Daylily Recalled for Undeclared Sulfites

    A & S Food Trading Inc. is recalling Gorgeous Memory brand Daylily due to undeclared sulfites detected by New York State authorities.

    Product
    GORGEOUS MEMORY brand Daylily, NET WT: 10.6 oz. (300 g), UPC 6 932960 968806, Product of China --- MINHANG FOOD CO., LTD, 103 Eldridge St., New York City, NY 10002 --- Nutrition Facts: Serving Size: 1 tbsp (100g), Servings Per Container: 4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0443-2016·2015-12-23

    Remel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs

    Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.

    Product
    Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0403-2016·2015-12-23

    Kerry Foods Recalls Blue Sanding Sugar Due to Metal Contamination

    Kerry Foods is recalling Sprinkle King Blue Sanding Sugar because it may contain metal. The voluntary recall affects 176,596 units distributed across 18 states.

    Product
    Sprinkle King, Blue Sanding Sugar, QBLU413.L32, , UPC:Inner: 00766818310303 ; Outer: 10766818310300, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0407-2016·2015-12-23

    Kerry Foods Recalls Sprinkle King Red Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling specific lots of Sprinkle King Red Sanding Sugar and Red Sugar because they may contain metal.

    Product
    Sprinkle King, Red Sanding Sugar,QRED413.L32, UPC:inner 766818312604; outer 10766818312601 , NET WT: 32 lb (14.51 kg). Sprinkle King, Red Sanding Sugar, QRED433.440, UPC: 10766818322655, NET WT: 40 lb (18.14 kg). Sprinkle King, Red Sugar,QRED443.00N, UP
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0394-2016·2015-12-23

    Metro Brand Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Contes Pasta Company is recalling Metro Brand Gluten Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Metro Brand Irresistibles Gluten Free Cheese Ravioli with Marinara Sauce Microwave Meal 340 g Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0395-2016·2015-12-23

    Conte's Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Conte's Pasta Company is recalling 1,020 cases of Gluten Free Wheat Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Conte's Gluten Free Wheat Free Cheese Ravioli Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158940092
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·15V877000·2015-12-23

    Entegra Motorhomes Recalled for Unstable Electric Entry Steps

    Entegra is recalling specific 2008-2011 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    ENTEGRA — ENTEGRA INSIGNIA, ASPIRE, CORNERSTONE, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0408-2016·2015-12-23

    Kerry Foods Recalls White Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling specific lots of Bake Sense and Sprinkle King white sanding sugar because they may contain metal.

    Product
    Bake Sense, White Sanding Sugar,m QWHI413.01, 52273, 92273 ( net wt 8 lb), UPC: inner 92273; outer 10018609922736, , NET WT: 32 lb (14.51 kg). Sprinkle King, White Sanding Sugar,QWHI413.L32, UPC:inner 766818313106, outer 10766818313103, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0437-2016·2015-12-23

    Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction

    Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.

    Product
    MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump sys
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0410-2016·2015-12-23

    Kerry Foods Recalls Cinnamon Topical G4205 Due to Metal Contamination

    Kerry Foods is voluntarily recalling Cinnamon Topical G4205 because it may contain metal. The recall covers 176,596 lbs distributed across 19 states.

    Product
    Kerry, Cinnamon Topical G4205, SS189, G4205.49, , UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 50 lb (22.68 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0409-2016·2015-12-23

    Kerry Foods Recalls Yellow Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Yellow Sanding Sugar because it may contain metal. The recall covers 32 lb bags distributed to 19 states.

    Product
    Sprinkle King, Yellow Sanding Sugar,QYEL413.L32, UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0399-2016·2015-12-23

    Kerry Foods Recalls Lime Green Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Lime Green Sanding Sugar because it may contain metal. The product was distributed to 18 states.

    Product
    Sprinkle King, Lime Green Sanding Sugar, 30611201.00N, UPC #30763089281012, NET WT: 150 lb (68.182 kg)
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·15V872000·2015-12-23

    Holiday Rambler and Monaco Motorhomes Recalled for Unstable Entry Steps

    Allied Recreation Group is recalling specific Holiday Rambler and Monaco motorhomes because a bolt on the electric entry steps may fracture, causing instability and injury risk.

    Product
    MONACO — MONACO, MONACO RV, SAFARI COACH DYNASTY, KNIGHT, LAPALMA, MONARCH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V875000·2015-12-23

    Forest River Recalls 2016 Prime Time Trailers with Incorrect Tire Placards

    Forest River is recalling 2016 Prime Time recreational trailers because the Federal placard lists the wrong tire load range, which may lead to overinflation and tire failure.

    Product
    PRIME TIME — PRIME TIME SPARTAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2016·2015-12-23

    Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure

    Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.

    Product
    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2016·2015-12-23

    Bestmed Digital Temple Thermometers Recalled for Inaccurate Temperature Readings

    Bestmed is recalling 305,548 digital temple thermometers sold under multiple retail brands because they display inaccurate, frequently lower temperatures than actual body temperature.

    Product
    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2016·2015-12-23

    MOOG Medical Devices Recalls EnteraLite Infinity Enteral Pump Delivery Sets

    MOOG Medical Devices Group is recalling EnteraLite Infinity Enteral Pump Delivery Sets because the purple ENFit connector may crack or break, causing leaks.

    Product
    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Conn
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0431-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V873000·2015-12-23

    H&H Trailers Recall 2015-2016 Utility and Bike Trailers for Hinge Defect

    H&H Trailers is recalling 1,847 model year 2015-2016 trailers because aluminum gate hinges may bend or break, potentially causing the gate to open unexpectedly.

    Product
    H&H — H&H RSA RAIL SIDE TANDEM AXLE, SSA SOLID SIDE TANDEM, AMS BIKE TRAILER, SSA SOLID SIDE SINGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2016·2015-12-23

    Philips Ingenuity CT Scanner Software Error Recalled by FDA

    The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error

    bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0393-2016·2015-12-23

    Metro Gluten Free Cheese Ravioli Recalled for Possible Salmonella Contamination

    Contes Pasta Company is recalling Metro Irresistibles Gluten Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Metro Irresistibles Gluten Free Cheese Ravioli 6- 9 ounce bags Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0413-2016·2015-12-23

    GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

    GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

    Product
    GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0416-2016·2015-12-23

    Girl Scouts Honey Mustard Pretzel Mix Recalled for Milk Allergen Mislabeling

    A. L. Schutzman Company, Inc. is recalling Girl Scouts Honey Mustard Pretzel Mix because the product lists whey but fails to declare milk in the 'Contains' statement.

    Product
    Honey Mustard Pretzel Mix sold under the following brand and size: Girl Scouts, NET WT 7 oz. (198g).
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2016·2015-12-23

    bioMerieux MYLA Software Recall for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records.

    Product
    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2016·2015-12-23

    Verathon GlideScope Video Laryngoscope Blades Recalled for Potential Separation

    Verathon is recalling GlideScope Video Laryngoscope blades because silicone adhesive may fail, causing the blade halves to separate during use.

    Product
    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2016·2015-12-23

    Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error

    Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.

    Product
    VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·15V876000·2015-12-23

    GM Recalls 2015 Chevrolet Cruze for Loose Seat Belt Bolts

    General Motors is recalling 2015 Chevrolet Cruze vehicles because a driver-side seat belt bolt may be loose. This defect could prevent the seat belt from holding in a crash.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0396-2016·2015-12-23

    Conte's Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Conte's Pasta Company is recalling gluten-free cheese ravioli with marinara sauce due to possible Salmonella contamination found in a raw product.

    Product
    Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158944458
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0429-2016·2015-12-23

    bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

    bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2016·2015-12-23

    Stryker Guidewire Introducer Needles Recalled for Expiration Date Issues

    Stryker is recalling 120 units of Guidewire Introducer Needles shipped after expiration or with minimal time remaining due to infection risk.

    Product
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2016·2015-12-23

    Myco Medical Supplies Recalls Unolok Blunt Fill Needles Due to Particulates

    Myco Medical Supplies Inc is recalling Unolok Blunt Fill Needles because complaints were received regarding rubber coring from injection vial closures.

    Product
    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2016·2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2016·2015-12-23

    Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction

    Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.

    Product
    MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0434-2016·2015-12-23

    Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors

    Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error

    bioMerieux, Inc. is recalling MYLA Clinic Patch 3.2.0 CD software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2016·2015-12-23

    GE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging

    GE Medical Systems is recalling 45 Optima IGS 320 systems due to a potential safety issue involving non-recoverable loss of displayed imaging.

    Product
    GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide

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