The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

601–700 of 1183

  • SevereFDA (Drugs)·D-1203-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1552-2015·2015-07-08

    Snoqualmie Almond Buttercrunch Toffee Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Almond Buttercrunch Toffee Gelato due to potential Listeria monocytogenes contamination.

    Product
    Almond Buttercrunch Toffee Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1559-2015·2015-07-08

    Snoqualmie Gianduja Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Gianduja Gelato due to potential Listeria monocytogenes contamination.

    Product
    Gianduja Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1545-2015·2015-07-08

    Snoqualmie Sorbet Base Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Sorbet Base due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Sorbet Base, sold under Snoqualmie brand. Product is sold in 2.5 gallon plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1520-2015·2015-07-08

    Snoqualmie Lime Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Lime Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Lime Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1533-2015·2015-07-08

    Snoqualmie Pear Ginger Sorbet Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Pear Ginger Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5-gallon tubs.

    Product
    Pear Ginger Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1550-2015·2015-07-08

    Snoqualmie Strawberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Strawberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Strawberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2015·2015-07-08

    Lincare Recalls Cefepime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Cefepime HCl IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1525-2015·2015-07-08

    Snoqualmie Mojito Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Mojito Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5-gallon tubs.

    Product
    Mojito Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1489-2015·2015-07-08

    Snoqualmie Apple Cider Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Apple Cider Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Apple Cider Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1204-2015·2015-07-08

    Lincare Recalls Ganciclovir Sodium Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific lots of Ganciclovir Sodium IV bags because the sterility of the product is not assured.

    Product
    Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1954-2015·2015-07-08

    ViewRay Treatment Planning Software Recalled for Location Calculation Failure

    ViewRay is recalling Treatment Planning and Delivery System Software version 3.6 because it fails to determine new patient locations if imaging is not enabled.

    Product
    Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-1494-2015·2015-07-08

    Snoqualmie Berry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Berry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1-gallon trays.

    Product
    Berry Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1526-2015·2015-07-08

    Snoqualmie Orange Pomegranate Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Orange Pomegranate Sorbet due to potential Listeria monocytogenes contamination.

    Product
    Orange Pomegranate Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1537-2015·2015-07-08

    Snoqualmie Pineapple Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Pineapple Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Pineapple Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1564-2015·2015-07-08

    Snoqualmie Peppermint Stick Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Peppermint Stick Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Peppermint Stick (with lecithin) Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays; 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1187-2015·2015-07-08

    Lincare Recalls Fentanyl Citrate IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fentanyl Citrate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1523-2015·2015-07-08

    Snoqualmie Mango Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Mango Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1569-2015·2015-07-08

    Snoqualmie Rosewater Pistachio Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Rosewater Pistachio Gelato due to potential Listeria monocytogenes contamination.

    Product
    Rosewater Pistachio Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1504-2015·2015-07-08

    Snoqualmie Coconut Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Coconut Sorbet due to the potential for Listeria monocytogenes contamination.

    Product
    Coconut Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V438000·2015-07-08

    Navistar Recalls 2013-2015 International TranStar Trucks for Fire Risk

    Navistar is recalling 2013-2015 International TranStar vehicles because a vent tube may detach, allowing engine oil to contact hot surfaces and cause a fire.

    Product
    INTERNATIONAL — INTERNATIONAL TRANSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1183-2015·2015-07-08

    Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Deferoxamine Mesylate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1902-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1873-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1171-2015·2015-07-08

    Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1499-2015·2015-07-08

    Snoqualmie Blueberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Blueberry Sorbet due to the potential for Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Blueberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1502-2015·2015-07-08

    Snoqualmie Coconut Pineapple Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Coconut Pineapple Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Coconut Pineapple Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1179-2015·2015-07-08

    Lincare Recalls Vancomycin HCl in Dextrose Due to Sterility Concerns

    Lincare, Inc. is recalling Vancomycin HCl in Dextrose compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1195-2015·2015-07-08

    Lincare Recalls Gentamicin Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.

    Product
    GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1554-2015·2015-07-08

    Snoqualmie Chocolate Gelato Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling 1.5-gallon tubs of Chocolate Gelato due to potential Listeria monocytogenes contamination.

    Product
    Chocolate Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1542-2015·2015-07-08

    Snoqualmie Raspberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Raspberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Raspberry Sorbet, sold under Snoqualmie brand. Product is sold in 1 gallon plastic trays; 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1485-2015·2015-07-08

    Snoqualmie Lemon Perfection Custard Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Lemon Perfection Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in various sizes.

    Product
    Lemon Perfection Custard, sold under Snoqualmie brand. Product is sold in 16 oz. (pint) paper cartons;1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 1200mg IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1190-2015·2015-07-08

    Lincare Recalls Diphenhydramine Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.

    Product
    Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1456-2015·2015-07-08

    Snoqualmie 13% Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 13% Ice Cream Mix due to potential Listeria monocytogenes contamination.

    Product
    13% Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.

    Product
    TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1539-2015·2015-07-08

    Snoqualmie Pomegranate Raspberry Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Pomegranate Raspberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Pomegranate Raspberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil 4800mg IV bags compounded in Arkansas because the sterility of the product is not assured.

    Product
    Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1170-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·15176·2015-07-08

    Barnett Outdoors Recalls Black Widow Slingshots Due to Injury Risk

    Barnett Outdoors is recalling Black Widow slingshots because the wrist strap can slip off, causing the slingshot to snap back and strike the user.

    Product
    Sports and hunting slingshots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1198-2015·2015-07-08

    Lincare Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling specific lots of Potassium Chloride IV bags because the sterility of the product is not assured.

    Product
    Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1201-2015·2015-07-08

    Lincare Recalls Ceftazidime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftazidime IV bags because the sterility of the product is not assured.

    Product
    Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2784-2015·2015-07-08

    Falcon Trading Recalls Desiccated Coconut Due to Metal Fragments

    Falcon Trading Co. is recalling desiccated coconut products due to the presence of stainless steel wire fragments. The affected product was distributed in several states.

    Product
    Conventional Desiccated Coconut - Medium Shred 25 lb. bags. Exp date: 20.11.2015 Item code: 001120; UPC: 086700011201 Imported by Falcon Trading Company Inc/Sun Ridge Farms, Royal Oaks, CA Country of Origin - Sri Lanka
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1510-2015·2015-07-08

    Snoqualmie Grapefruit Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Grapefruit Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Grapefruit Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagent because it may produce falsely decreased results when used with certain drugs.

    Product
    Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2015·2015-07-08

    US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect

    US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.

    Product
    Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2015·2015-07-08

    Covidien Recalls Chronic Catheter Kits for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2015·2015-07-08

    GE Healthcare Radiographic Systems Recalled for Safety Mechanism Failure

    GE Healthcare is recalling Precision 500D and Advantx Legacy systems because a safety mechanism may fail to engage, posing a risk of injury from falling equipment.

    Product
    GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or sup
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Deficiency

    FDA Class II recall of Palindrome SI Chronic Catheter Sport Packs by Covidien LLC due to potential failure to meet antimicrobial specifications.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2015·2015-07-08

    Atrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.

    Product
    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheters for Antimicrobial Issues

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2783-2015·2015-07-08

    Frontiere Natural Meats Recalls Ground Elk Meat for E. coli O157:H7

    Frontiere Natural Meats is recalling 16-ounce packages of ground elk meat due to potential contamination with Escherichia coli O157:H7.

    Product
    Ground Elk meat packaged individually for retail sale in hermetically sealed plastic with a black backing identified with Use or Freeze By 04-27-15. The stick-on finished product label is red, white, and black with red, white, and black print writing reading in part: "Natural DK
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1881-2015·2015-07-08

    Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2015·2015-07-08

    Sechrist Low Profile Wheeled Stretcher Recalled for Unexpected Incline During Height Adjustment

    Sechrist Industries is recalling Low Profile Wheeled Stretchers because they may unexpectedly incline during height adjustment, posing a risk to patients.

    Product
    Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, 21762-111-36H.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1864-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 520 Angiographic X-ray Systems

    GE Healthcare is recalling 10 Innova IGS 520 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheters Recalled for Antimicrobial Specification Failures

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1964-2015·2015-07-08

    Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements

    Hamilton Medical is recalling Infant Flow Sensors because they may provide inaccurate flow measurements, causing ventilators to decrease ventilation in specific modes.

    Product
    Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2015·2015-07-08

    Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2015·2015-07-08

    Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2015·2015-07-08

    Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements

    Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.

    Product
    Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2015·2015-07-08

    Siemens Recalls Syngo Imaging Software Due to Display and Measurement Errors

    Siemens is recalling Syngo Imaging software versions V30 and V31 because safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non-square pixel size.

    Product
    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1854-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed worldwide with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2015·2015-07-08

    FDA Recalls Palindrome Precision Chronic Catheters for Antimicrobial Specification Failure

    FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2015·2015-07-08

    Sheffield Pharmaceuticals Recalls LUBRI GEL Due to B. cepacia Contamination

    Sheffield Pharmaceuticals is recalling specific lots of Dr. Sheffield's LUBRI GEL personal lubricant after testing revealed high counts of gram-positive rods and B. cepacia.

    Product
    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1858-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2015·2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Failure

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V437000·2015-07-08

    Kidron Refrigerated Trailers Recalled for Wiring Harness Defect Affecting ABS

    VT Hackney is recalling 2014-2015 Kidron Refrigerated Trailers because a wiring harness may not supply adequate power to the rear connector, potentially disabling the anti-lock brake system on a second trailer in doubles operation.

    Product
    KIDRON — KIDRON REFRIGERATED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V439000·2015-07-08

    Honda Recalls Multiple Motorcycles Due to Starter Relay Sealant Defect

    Honda is recalling specific 2013-2016 motorcycles because incorrect sealant on the starter relay may cause electrical power loss and engine stalling.

    Product
    HONDA — HONDA VT750, CB500, CB300F, NC700X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V436000·2015-07-08

    Ford Recalls 2015 Focus, C-Max, and Escape for Engine Shutdown Defect

    Ford is recalling 2015 Focus, C-Max, and Escape vehicles because the engine may continue running after being turned off, increasing the risk of an unintentional crash.

    Product
    FORD — FORD FOCUS, C-MAX, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2015·2015-07-08

    GE Healthcare Recalls Optima CL 323i Angiographic X-ray Systems

    GE Healthcare is recalling seven Optima CL 323i angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2015·2015-07-08

    Biomet Gentle Threads Interference Screw Recall Due to Product Mix-Up

    Biomet is recalling Gentle Threads Interference Screws because two different part numbers were mixed. Using the incorrect screw may lead to failure or revision surgery.

    Product
    Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1944-2015·2015-07-08

    Biomet Recalls Gentle Threads Interference Screws Due to Lot Mixing

    Biomet is recalling 53 units of Gentle Threads Interference Screws because they were mixed with a different size, posing a risk of surgical failure.

    Product
    Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1922-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.

    Product
    Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2015·2015-07-08

    Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.

    Product
    EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2015·2015-07-08

    Medtronic Recalls Navigated Cannulated Taps Due to Cleaning Injury Risk

    Medtronic Navigation is correcting 15,798 Navigated Cannulated Taps distributed worldwide due to a potential for injury during the cleaning process.

    Product
    Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1934-2015·2015-07-08

    Siemens SOMATOM Emotion 6 CT Scanner Recall for Broken Screws

    Siemens Medical Solutions is recalling 40 SOMATOM Emotion 6 CT scanners due to broken or bowed screws securing the gantry balance weight.

    Product
    SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2015·2015-07-08

    Tecan Infinite M1000 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2015·2015-07-08

    Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk

    Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.

    Product
    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1955-2015·2015-07-08

    JustRight 5mm Stapler Recalled for Incomplete Staple Formation

    Justright Surgical is recalling JustRight 5mm Staplers because they may deliver incomplete staple formation and incomplete tissue closure.

    Product
    JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and cre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 630 Angiographic X-ray Systems

    GE Healthcare is recalling eight Innova IGS 630 angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 620 Angiographic X-ray Systems

    GE Healthcare is recalling three Innova IGS 620 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2015·2015-07-08

    GE Healthcare Recalls Angiographic X-ray Systems Due to Motion Loss

    GE Healthcare is recalling three Discovery and Innova IGS 740 angiographic X-ray systems because they may lose C-arm gantry motion capability.

    Product
    GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2015·2015-07-08

    Varian VariSource iX Afterloader Systems Recalled for Calculation Errors

    Varian Medical Systems is recalling 55 VariSource iX afterloader systems because a software freeze can cause incorrect radiation dose calculations.

    Product
    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherap
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1965-2015·2015-07-08

    Hamilton Medical Infant Flow Sensor Recalled for Inaccurate Ventilation Measurements

    Hamilton Medical is recalling Infant Flow Sensors because inaccurate flow measurements may cause ventilators to decrease ventilation delivery.

    Product
    Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2015·2015-07-08

    GE Healthcare Recalls Innova 3100IQ Angiographic X-ray Systems

    GE Healthcare is recalling six Innova 3100IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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