The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
159
Severe
434
High
277
Moderate
532
Low
21

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 30% are Severe.

1301–1400 of 1423

  • SevereFDA (Food)·F-0335-2014·2014-01-01

    Reser's Oil & Vinegar Cole Slaw Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Oil & Vinegar Cole Slaw due to potential Listeria monocytogenes contamination. The product was distributed across 41 U.S. states and Canada.

    Product
    Reser's Oil & Vinegar Cole Slaw, Formula CS.50, packaged in 2/9-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0302-2014·2014-01-01

    Reser's Three Potato Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Three Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Reser's Three Potato Salad, Formula PO.68, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Devices)·Z-0534-2014·2014-01-01

    CareFusion Recalls Alaris PC Units Due to System Error Messages

    CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

    Product
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0288-2014·2014-01-01

    Reser's Potato Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Homestyle Recipe Potato Salad with Egg due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Reser's Homestyle Recipe Potato Salad with Egg, Formula PO.81, packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0340-2014·2014-01-01

    Reser's Fine Foods Recalls Dillon's Cole Slaw Due to Listeria Risk

    Reser's Fine Foods is recalling Dillon's Cole Slaw because it may be contaminated with Listeria monocytogenes. The product was distributed in 40 states and Canada.

    Product
    Dillon's Cole Slaw, Formula CS.86, packaged in 12/14-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0295-2014·2014-01-01

    Reser's Yoder's Mustard Potato Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Yoder's Mustard Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Yoder's Mustard Potato Salad, Formula PO.185, packaged in 2/5-lb carton cases. Distributed by Lipari Foods, Warren, MI.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Drugs)·D-387-2014·2014-01-01

    FDA Recalls Imitrex STATdose Systems Due to Sterility Concerns

    GlaxoSmithKline is recalling 10,469 Imitrex STATdose Systems because some syringes may have needles protruding through the shield, compromising sterility.

    Product
    IMITREX — IMITREX (SUMATRIPTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0291-2014·2014-01-01

    Reser's Red Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Dillons Red Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed in 41 states and Canada.

    Product
    Dillons Red Potato Salad, Formula PO.87, packaged in 12/16-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0341-2014·2014-01-01

    Reser's Coleslaw Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling Cobblestreet Market Short Shredded Coleslaw due to potential Listeria monocytogenes contamination. The product was distributed across many US states and Canada.

    Product
    Cobblestreet Market Short Shredded Coleslaw, Formula CS.91, packaged in 12/14-oz carton cases. Marketed by Independent Marketing Alliance, Houston, TX.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1152-2014·2014-01-01

    Reser's Cookies and Cream Desserts Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Cookies and Cream Desserts potentially contaminated with Listeria monocytogenes. Consumers should check use-by dates and discard affected products.

    Product
    Reser's Cookies and Cream Desserts, Formula DE.09, packaged in 2/6-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0331-2014·2014-01-01

    Reser's Coleslaw Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling various coleslaw products due to potential Listeria monocytogenes contamination. The products were distributed to 41 states and Canada.

    Product
    Coleslaw, Formula CS.29, packaged under the following labels: -Essential Everyday Cole Slaw packaged in 6/15-oz and 6/44-oz carton cases. Distributed by Supervalu Inc., Eden Prairie, MN. -US Food Service Cross Valley Farms Cole Slaw packaged in 2/7-lb carton cases. Distributed…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1246-2014·2014-01-01

    Reser's Market Pantry Macaroni Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Market Pantry Macaroni Salad due to potential Listeria monocytogenes contamination. The product was distributed in 38 US states and Canada.

    Product
    Market Pantry Macaroni Salad, Formula MA.102, packaged in 12/454-gm container/cases. Distributed by Target Canada, Mississauga, ON L4W 0C4. UPC 628919002399
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0238-2014·2014-01-01

    Reser's Red Potato Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Red Potato Salad products potentially contaminated with Listeria monocytogenes. Affected items were distributed across 40 US states and Canada.

    Product
    Red Potato Salad, Formula PO.37, packaged under these labels: -Reser's Red Potato Salad, packaged in 6/16-oz (UPC 071117190052), 6/3-lb (UPC 071117004816) carton cases. -Stonemill Kitchens, Country Red Potato Salad, packaged in 6/4-lb (UPC 071117616842) carton cases.…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0287-2014·2014-01-01

    Reser's Red Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Red Potato Salad with Sour Cream & Dill due to potential Listeria monocytogenes contamination. The product was distributed across many US states and Canada.

    Product
    Red Potato Salad with Sour Cream & Dill, Formula PO.80, packaged under these labels: -Reser's Red Potato Salad with Sour Cream & Dill packaged in 2/8-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Block & Barrel Red Skinned Potato Salad with Sour Cream & Dill…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0293-2014·2014-01-01

    Reser's Loaded Baked Potato Salad Base Recalled for Listeria Risk

    Reser's Fine Foods is recalling Loaded Baked Potato Salad Base due to potential Listeria monocytogenes contamination. The product was distributed to 40 states and Canada.

    Product
    Reser's Loaded Baked Potato Salad Base, Formula PO.161, packaged in 2/5.5-lb carton cases. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1172-2014·2014-01-01

    Reser's Honey Chicken Salad Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Honey Chicken Salad Kits potentially contaminated with Listeria monocytogenes. Consumers should check use-by dates and discard affected products.

    Product
    Reser's Honey Chicken Salad Kit, Formula DR.107B32, packaged in 6/32-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147292
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0290-2014·2014-01-01

    Reser's Dillons Mustard Potato Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Dillons Mustard Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Dillons Mustard Potato Salad, Formula PO.86, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0264-2014·2014-01-01

    Reser's Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Country Potato Salad products due to potential Listeria monocytogenes contamination. The recall affects multiple brands and distribution states.

    Product
    Country Potato Salad, Formula PO.15, packaged under these labels: - Cross Valley Farms Country Style Potato Salad with Egg, in 2/8-lb carton cases. Distributed by U.S. Foodservice, Inc., Rosemont, IL. UPC 758108301511 -Reser's Country Potato Salad, in 3/8-lb carton…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0306-2014·2014-01-01

    Reser's Italian Pasta Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Italian Pasta Salad products under multiple brand names due to potential Listeria monocytogenes contamination.

    Product
    Italian Pasta Salad Formula PA.42, packaged under these labels: Independent Marketing Alliance Italian Pasta Salad in 2/8 lb containers. Marketed by Independent Marketing Alliance Houston, TX. Cross Valley Farms Fresh Salad in 2/8 lb containers. Distributed by U.S.…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1228-2014·2014-01-01

    Reser's Roasted Corn and Black Bean Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Roasted Corn & Black Bean Salad due to potential Listeria monocytogenes contamination. The product was distributed across 41 US states and Canada.

    Product
    Reser's Roasted Corn & Black Bean Salad, Formula VE.104 packaged in 2/5-lb (UPC 071117141955) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1134-2014·2014-01-01

    MegaFood Gluten & Dairy Megazymes Recalled for Chloramphenicol Contamination

    FoodState is recalling MegaFood Gluten & Dairy Megazymes 30ct and 60ct due to potential chloramphenicol contamination.

    Product
    MegaFood Gluten & Dairy Megazymes 30ct. (10218) and MegaFood Gluten & Dairy Megazymes 60ct. (10219)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1182-2014·2014-01-01

    Reser's Loaded Antipasto Pasta Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Loaded Antipasto Pasta Kits due to potential Listeria monocytogenes contamination. Affected products were distributed across 41 US states and Canada.

    Product
    Reser's Loaded Antipasto Pasta Kit, Formula KI.10, packaged in 3/6.13-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1206-2014·2014-01-01

    Reser's Classic Egg Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Classic Egg Salad due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    Reser's Classic Egg Salad, Formula PT.141 packaged in 2/3-lb (UPC 071117060492) and 2/5-lb (UPC 071117141344) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1217-2014·2014-01-01

    Reser's Deli Counter Tuna Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling The Deli Counter Premium Tuna Salad due to potential Listeria monocytogenes contamination. The product was distributed in 48 states and Canada.

    Product
    The Deli Counter Premium Tuna Salad, Formula PT.61 packaged in 6/15-oz (UPC 021130067428) and 2/3-lb (UPC 071117060362) carton cases. Distributed by Safeway Inc., Pleasanton, CA.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1215-2014·2014-01-01

    Reser's Seafood Salad Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling Seafood Salad products due to potential Listeria monocytogenes contamination. The products were distributed to 41 US states and Canada.

    Product
    Seafood Salad, Formula PT.48 packaged under these labels: -Cross Valley Farms Seafood Salad packaged in 2/8-lb (UPC 758108301566) carton cases. Distributed by US Foodservice, Inc., Rosemont, IL. -Reser's Seafood Salad Base packaged in 2/8-lb carton cases. Reser's Fine…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0326-2014·2014-01-01

    Reser's Fine Foods Recalls Coleslaw Products Due to Listeria Risk

    Reser's Fine Foods is recalling specific coleslaw products sold under Aldi, Reser's, and Yoder's labels due to potential Listeria monocytogenes contamination.

    Product
    Coleslaw, Formula CS.08, packaged under these labels: -Aldi Little Salad Bar Creamy Coleslaw packaged in 6/30-oz carton cases. Distributed by: ALDI Inc., Batavia, IL. -Reser's Amish Cole Slaw packaged in 2/7-lb carton cases. Reser's Fine Foods, Beaverton, OR. -Yoder's…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0258-2014·2014-01-01

    Reser's Deli Counter Loaded Baked Potato Salad Recalled for Listeria Risk

    Reser's Fine Foods is recalling Loaded Baked Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed in 42 states and Canada.

    Product
    The Deli Counter Loaded Baked Potato Salad, Formula PO.163, packaged in 12/16-oz carton cases. Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA. UPC 021130068463
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Drugs)·D-390-2014·2014-01-01

    Physicians Total Care Recalls Carisoprodol Tablets Due to Foreign Substance

    Physicians Total Care is recalling Carisoprodol 350mg tablets because heavy metals and inactive components were found during routine stability testing.

    Product
    Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count…
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1249-2014·2014-01-01

    Reser's Fine Foods Recalls Cucumber Salad Due to Listeria Risk

    Reser's Fine Foods is recalling Cucumber & Onion Salad products potentially contaminated with Listeria monocytogenes. The recall covers specific use-by dates distributed across the US and Canada.

    Product
    Cucumber & Onion Salad, Formula VE.17, packaged under the following labels: Reser's Fine Foods Cucumber & Onion Salad packaged in 2/8-lb (UPC 071117142839) carton/cases. Reser's Fine Foods, Inc., Beaverton, OR. Cross Valley Farms Cucumber Salad packaged in 2/8-lb carton…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0259-2014·2014-01-01

    Stonemill Kitchens Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Stonemill Kitchens Texas Potato Salad due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    Stonemill Kitchens Texas Potato Salad, Formula PO.167, packaged in 6/5-lb, carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117615586
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0312-2014·2014-01-01

    Reser's Pasta Spinachi Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling specific lots of Pasta Spinachi with Cavatappi due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    Pasta Spinachi with Cavatappi Formula PA.111, packaged under these labels: Resers Pasta Spinachi with Cavatappi in 2/4.5 lb containers. Resers Fine Foods, Inc. Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1247-2014·2014-01-01

    Reser's Egg Salad Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling specific lots of egg salad due to potential Listeria monocytogenes contamination. The products were distributed across 41 states and Canada.

    Product
    Egg Salad, Formula PT.21, packaged under the following labels: Cross Valley Farms Egg Salad packaged in 2/5-lb carton/cases. Distributed by Cross Valley Farms, Columbia, MD. USPC 758108301634 Dreser's Egg Salad packaged in 2/5-lb carton/cases. Distributed by Dreser's Fine…
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1255-2014·2014-01-01

    Aunt Jemima Cornmeal Mix Recalled for Aflatoxin Levels Above Legal Limit

    Quaker Foods and Snacks North America is recalling Aunt Jemima Buttermilk Self-Rising White Cornmeal Mix because it contains aflatoxin levels above the legal limit.

    Product
    Buttermilk Self-Rising White Cornmeal Mix sold under the Aunt Jemima brand and packaged in a paper bag with a net weight of 32 oz. (2 lb.) 907 g.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1240-2014·2014-01-01

    Reser's Smokehouse BBQ Beans Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Smokehouse BBQ Beans due to potential Listeria monocytogenes contamination. The products were distributed to 41 states and Canada.

    Product
    Reser's Smokehouse BBQ Beans, Formula VE.99, packaged in 2/8-lb (UPC 071117141726) and 6/16-oz (UPC 71117183399) carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0286-2014·2014-01-01

    Reser's Potato Salad Recalled for Listeria Contamination Risk

    Reser's Fine Foods is recalling Dillons Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Dillons Potato Salad, Formula PO.76, packaged in 6/4-lb, 12/16-oz and 6/32-oz carton cases. Distributed by Dillons Stores, Hutchinson, KS.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-0252-2014·2014-01-01

    Reser's Walmart Deli Potato Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Walmart Deli Potato Salad due to potential Listeria monocytogenes contamination. The product was distributed across 41 US states and Canada.

    Product
    Walmart Deli Potato Salad, Formula PO.121, packaged in 12/16-oz (UPC 681131916783), 6/32-oz (UPC 681131916844) and 6/4-lb (UPC 681131916905) carton cases. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1133-2014·2014-01-01

    MegaFood Vegan-Ease Recalled for Potential Chloramphenicol Contamination

    FoodState is recalling MegaFood Vegan-Ease products due to potential chloramphenicol contamination. Consumers should stop using the affected lots.

    Product
    MegaFood Vegan-Ease 30 ct. (12002) and MegaFood Vegan-Ease 2 ct. Sample Pack (S12002)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0315-2014·2014-01-01

    Reser's Thai Noodle Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Thai Noodle Salad due to potential Listeria monocytogenes contamination. Consumers should discard the product.

    Product
    Thai Noodle Salad Formula PA.141, packaged under these labels: Thai Noodle Salad in 2/5 lb containers.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1188-2014·2014-01-01

    Stonemill Tomato Mozzarella Pasta Salad Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Stonemill Tomato Mozzarella Pasta Salad due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Stonemill Tomato Mozzarella Pasta Salad, Formula KI.31, packaged in 2/4.64-lb carton cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Food)·F-1164-2014·2014-01-01

    Reser's Fine Foods Recalls Spinach Dip for Listeria Contamination

    Reser's Fine Foods is recalling Jewel Chef's Kitchen Spinach Dip due to potential Listeria monocytogenes contamination. The product was distributed in 41 US states and Canada.

    Product
    Jewel Chef's Kitchen Spinach Dip, Formula DI.39, packaged in 12/16-oz and 6/12-oz carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. (16-oz package distributed by Jewel Food Stores, Inc., Melrose Park, IL.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0559-2014·2014-01-01

    B. Braun IV Catheters Recalled for Missing Safety Clip

    B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.

    Product
    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1175-2014·2014-01-01

    Reser's Cole Slaw Dressing Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Cole Slaw Dressing due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    Reser's Cole Slaw Dressing, Formula DR.14, packaged in 2/4-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147520 pH: 2.86 +/- 0.2
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1209-2014·2014-01-01

    Reser's and Safeway Cajun Krab Dip Recalled for Listeria Risk

    Reser's Fine Foods is recalling specific lots of Cajun Krab Dip due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    Krab Dip, Formula PT.152 packaged under these labels: -Reser's Cajun Krab Dip packaged in 2/5-lb (UPC 071117169010) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. -Safeway Cajun Krab Dip packaged in 6/7-oz (UPC 021130124183) carton cases. Reser's Fine Foods…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1150-2014·2014-01-01

    Taylor Farms Recalls Coleslaw Kits Due to Listeria Risk

    Taylor Farms Texas is recalling coleslaw kits containing Reser's dressing due to possible Listeria monocytogenes contamination.

    Product
    CabG Coleslaw Kit with Dressing TF 12.56#, 1400265, Net Weight: 12.5 Lbs, Ingredients: Green Cabbage, Carrots, Dressing; Distributed by Taylor Farms Texas, Dallas, TX 75211
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1243-2014·2014-01-01

    Reser's Broccoli Salad Dressing Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific bags of Broccoli Salad Dressing due to potential Listeria monocytogenes contamination. The product was distributed to 40 states and Canada.

    Product
    Reser's Broccoli Salad Dressing, Formula DR.92B18, packaged in 18/18-oz (UPC 071117061024) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1115-2014·2014-01-01

    Lewis Bakeries Recalls White Bread Due to Stainless Steel Fragments

    Lewis Bakeries-Evansville is recalling 365,847 loaves of white bread nationwide because two small food-grade stainless steel fragments were found in two slices.

    Product
    White bread packaged under the following names and sizes: UPC Name, size 71025-00269 Holsum, Sof-Twist, Giant, 24 OZ 24126-01025 Bunny, Thin Sandwich, 24 OZ 71302-04738 Sunbeam, KING, 24 OZ 71025-00512 Harts, HOME STYLE, 24 OZ 71025-00040 Lewis, CIRCLE B…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2014·2014-01-01

    Varian Eclipse Treatment Planning System Software Deficiency Recall

    Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.

    Product
    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1223-2014·2014-01-01

    Reser's Fine Foods Recalls Margarita Salsa Due to Listeria Risk

    Reser's Fine Foods is recalling specific batches of Margarita Salsa because they may be contaminated with Listeria monocytogenes.

    Product
    -Reser's Baja Cafe Margarita Salsa, Formula SA.40 packaged in 2/5-lb carton cases UPC 071117001327. Reser's Fine Foods, Inc., Beaverton, OR. Also labeled: Casa Solana Margarita Salsa packaged in 2/5-lb carton cases UPC 074865776394. Distributed by Sysco Corporation…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1143-2014·2014-01-01

    Vega ONE Nutritional Shake Recalled for Chloramphenicol Contamination

    Sequel Naturals is recalling nine lots of Vega ONE Nutritional Shake Vanilla Chai due to trace amounts of chloramphenicol.

    Product
    Vega ONE Nutritional Shake Vanilla Chai. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.8 oz./874 g, 38g, 437g units containers.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1242-2014·2014-01-01

    Reser's Chicken Salad Dressing Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Chicken Salad Dressing due to potential Listeria monocytogenes contamination. The product was distributed to 41 US states and Canada.

    Product
    Reser's Chicken Salad Dressing, Formula DR.49B64, packaged in 5/4-lb (UPC 071117060355) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1221-2014·2014-01-01

    Reser's Fine Foods Recalls Jewel Chef's Kitchen Salsa for Listeria Risk

    Reser's Fine Foods is recalling Jewel Chef's Kitchen Salsa Medium due to potential Listeria monocytogenes contamination. The product was distributed across 40 US states and Canada.

    Product
    Jewel Chef's Kitchen Salsa Medium, Formula SA.28 packaged in 6/16-oz carton cases UPC 041280011263. Distributed by Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1138-2014·2014-01-01

    Kettle Cuisine Recalls Phillips Lobster Bisque Due to Undeclared Wheat

    Kettle Cuisine, Inc. is recalling Phillips Food Service Lobster Bisque because it contains undeclared wheat. The product was distributed to specific states.

    Product
    Phillips Food Service Lobster Bisque, 4 lb cryobag, frozen Item #45036
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0556-2014·2014-01-01

    McKesson Radiology 12.0 PACS Recall for Missing Contrast Allergy Data

    McKesson Information Solutions LLC is recalling McKesson Radiology 12.0 PACS because merging patient records may result in missing contrast allergy information.

    Product
    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·f-1220-2014·2014-01-01

    Reser's Fine Foods Recalls Jewel Chef's Kitchen Salsa Mild Due to Listeria Risk

    Reser's Fine Foods is recalling Jewel Chef's Kitchen Salsa Mild due to potential Listeria monocytogenes contamination. The product was distributed to 40 states and Canada.

    Product
    Jewel Chef's Kitchen Salsa Mild, Formula SA.27 packaged in 6/16-oz carton cases UPC 041280095560. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-0394-2014·2014-01-01

    Taylor Farms Diced Summer Slaw Recalled for Listeria Risk

    Taylor Farms is recalling Diced Summer Slaw kits because they contained Reser's salad dressing recalled for possible Listeria monocytogenes contamination.

    Product
    DICED SUMMER SLAW, 310140, TAYLOR FARMS 1/5.25, NET WT: 5 lbs; 2 PK, 310138, TAYLOR FARMS 2/1.25, NET WT: 10.5, TAYLOR FARMS, MD
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1173-2014·2014-01-01

    Reser's Chicken Salad Dressing Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Chicken Salad Dressing potentially contaminated with Listeria monocytogenes. Consumers should check use-by dates and discard the product.

    Product
    Reser's Chicken Salad Dressing, Formula DR.12, packaged in 2/8-lb carton cases. Distributed by Reser's Fine Foods, Beaverton, OR. UPC 071117147612
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1244-2014·2014-01-01

    Reser's Cole Slaw Dressing Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Cole Slaw Dressing due to potential Listeria monocytogenes contamination. The product was distributed to 41 states and Canada.

    Product
    Reser's Cole Slaw Dressing, Formula DR.93B20, packaged in 18/20-oz (UPC 071117061031) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0581-2014·2014-01-01

    Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues

    Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.

    Product
    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1120-2014·2014-01-01

    Lewis Bakeries Recalls Cinnamon Bread Due to Metal Fragments

    Lewis Bakeries-Evansville is recalling 18,360 loaves of Cinnamon Bread because two small food-grade stainless steel fragments were found in two slices.

    Product
    UPC Name 6000283495 Cinnamon Bread (bulk)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2014·2014-01-01

    EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error

    EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.

    Product
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1135-2014·2014-01-01

    FoodState Recalls Innate Response Digestive Enzymes for Chloramphenicol Contamination

    FoodState is recalling Innate Response Digestive Enzymes due to potential chloramphenicol contamination. Consumers should stop using the product and return it to the point of purchase.

    Product
    Innate Response Digestive Enzymes Clinical Strength 90ct. (40126) and " Innate Response Digestive Enzymes Clinical Strength 10 Ct. Sample (90037)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1250-2014·2014-01-01

    Reser's Baja Cafe Mango Salsa Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Baja Cafe Mango Salsa due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and stop using the product.

    Product
    Reser's Baja Cafe Mango Salsa, Formula SA.10, packaged in 2/5-lb (UPC 071117002829) carton/cases. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0570-2014·2014-01-01

    Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error

    Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.

    Product
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1224-2014·2014-01-01

    Reser's Pico De Gallo Salsa Recalled for Listeria Contamination

    Reser's Fine Foods is recalling specific cases of Baja Cafe Pico De Gallo Salsa due to potential Listeria monocytogenes contamination.

    Product
    -Reser's Baja Cafe Pico De Gallo Salsa, Formula SA.70 packaged in 2/5-lb carton cases UPC 071117001341. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-0396-2014·2014-01-01

    Taylor Farms Salad Kits Recalled for Possible Listeria Contamination

    Taylor Farms is recalling 1,312 units of Kit Cole Slaw salad kits because the included Reser's dressing was recalled for possible Listeria monocytogenes contamination.

    Product
    KIT COLE SLAW, 310160, TAYLOR FARMS 12.5#, NET WT: 12, TAYLOR FARMS, MD
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1149-2014·2014-01-01

    Taylor Farms Broccoli Slaw Crunch Kit Recalled for Listeria Risk

    Taylor Farms Florida is recalling Broccoli Slaw Crunch Kits because the included salad dressing was recalled for possible Listeria monocytogenes contamination.

    Product
    BROCCOLI, SLAW CRUNCH KIT, 390260, 1/6.55#
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0395-2014·2014-01-01

    Taylor Farms Salad Kits Recalled for Possible Listeria Contamination

    Taylor Farms is recalling 136 units of Kings Summer Slaw salad kits because the included dressing was recalled for possible Listeria monocytogenes contamination.

    Product
    KINGS SUMMER SLAW, 310161, TAYLOR FARMS 4.75#, NET WT: 4, TAYLOR FARMS, MD
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1151-2014·2014-01-01

    Taylor Farms Italian Pasta Salad Kits Recalled for Listeria Risk

    Taylor Farms is recalling Italian Pasta Salad kits because they contain dressing from a supplier recalled for possible Listeria contamination.

    Product
    Kit, Salad Italian Pasta PPC SWY 1/5.67#, 2900070, Net Weight: 5.67Lbs, Distributed by Taylor Farms Texas, Dallas, TX 75211
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1148-2014·2014-01-01

    Fresh Foods Diced Summer Slaw Salad Kit Recalled for Listeria Risk

    Fresh Foods Manufacturing Co. is recalling Diced Summer Slaw Salad Kits because they included a dressing package under recall for possible Listeria monocytogenes contamination.

    Product
    Diced Summer Slaw Salad Kit Fresh Food Manufacturing Company 10.5 lbs
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-384-2014·2014-01-01

    Tower Pharmacy Recalls Phenylephrine Nasal Spray Due to Microbial Contamination

    Tower Pharmacy is recalling Phenylephrine Nasal Spray 1% due to possible microbial contamination. The affected product is for office use and was distributed in California.

    Product
    Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1122-2014·2014-01-01

    Lewis Bakeries Recalls French Toast Bread Due to Metal Fragments

    Lewis Bakeries is recalling French Toast Whole Wheat bread after finding two small stainless steel fragments in two slices.

    Product
    UPC Name 6000050617 French Toast Whole Wheat (bulk)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2014·2014-01-01

    Taylor Farms Broccoli Cheddar Pasta Salad Kits Recalled for Listeria Risk

    Taylor Farms is recalling Broccoli Cheddar Pasta Salad Kits because they contained dressing from Reser's that was recalled for possible Listeria monocytogenes contamination.

    Product
    KIT BROCCOLI CHEDDAR PASTA, 310087, TAYLOR FARMS 8.56#, NET WT: 8.56, TAYLOR FARMS, MD
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0577-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0398-2014·2014-01-01

    Taylor Farms Recalls Italia Pasta Kits Due to Listeria Risk

    Taylor Farms is recalling Italia Pasta Kits because they contain salad dressing from Reser's that was recalled for possible Listeria monocytogenes contamination.

    Product
    ITALIA PASTA KIT, 310168 SAFEWAY 1/5.69#, NET WT: 5.69, S2560, DISTRIBUTED BY LUCERNE FOODS, INC. PO BOX 99, PLEASANTON, CA945, 95466-009, 1-877-232-4271
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1118-2014·2014-01-01

    Lewis Bakeries Recalls Honey Wheat Bread Due to Metal Fragments

    Lewis Bakeries is recalling 89,471 loaves of Honey Wheat Bread nationwide because two small stainless steel fragments were found in the product.

    Product
    Honey Wheat Bread packaged under the following names and sizes: UPC Name, size 24126-01435 Bunny, Honey Wheat, 20 OZ 71025-00443 Holsum, Honey Wheat, 20 OZ 78742-03639 Honey Wheat Great Value, Honey Wheat, 20 OZ 24126-01511 Honey Wheat Schnucks Select, Honey…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2014·2014-01-01

    Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives

    Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.

    Product
    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1116-2014·2014-01-01

    Lewis Bakeries Recalls Whole Grain White Bread Due to Metal Fragments

    Lewis Bakeries is recalling 40,741 loaves of Whole Grain White Bread because two small food-grade stainless steel fragments were found in two slices.

    Product
    Whole Grain White Bread packaged under the following names and sizes: UPC Name, size 24126-01449 Bunny, Whole Grain White, 20 OZ 24126-01450 Holsum, Whole Grain White, 20 OZ 78742-03638 Great Value, Whole Grain White, 20 OZ 24126-01557 Healthy Life Soft Style…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1119-2014·2014-01-01

    Lewis Bakeries Recalls Yellow Bread Due to Stainless Steel Fragments

    Lewis Bakeries-Evansville is recalling 87,210 loaves of bulk yellow bread because two small food-grade stainless steel fragments were found in two slices.

    Product
    UPC Name 6000283494 Yellow bread (bulk)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1245-2014·2014-01-01

    Reser's Italian Dressing Recalled for Potential Listeria Contamination

    Reser's Fine Foods is recalling specific lots of Italian Dressing due to potential Listeria monocytogenes contamination. The product was distributed to many US states and Canada.

    Product
    Reser's Italian Dressing, Formula DR.97B32, packaged in 12/32-oz (UPC 071117061017) carton cases. Reser's Fine Foods, Inc., Beaverton, OR. *This is a bagged dressing that does not have a pre-printed label. Ingredient statement and code date information is ink jet printed…
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1144-2014·2014-01-01

    Vega ONE Nutritional Shake Recalled for Chloramphenicol Contamination

    Sequel Naturals is recalling nine lots of Vega ONE Nutritional Shake Natural due to trace contamination by chloramphenicol.

    Product
    Vega ONE Nutritional Shake Natural. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.4oz/862g, 35.9g, and 431g containers.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1225-2014·2014-01-01

    Reser's Baja Cafe Salsa Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Baja Cafe Original Salsa due to potential Listeria monocytogenes contamination. Consumers should check use-by dates and discard affected products.

    Product
    -Reser's Baja Cafe Original Salsa, Formula SA.83 packaged in 2/5-lb carton cases UPC 071117001518. Reser's Fine Foods, Inc., Beaverton, OR.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0583-2014·2014-01-01

    Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2014·2014-01-01

    Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2014·2014-01-01

    Siemens Dimension Chemistry Wash Recalled for Result Shifts

    Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.

    Product
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2014·2014-01-01

    Ziehm Vision R C-Arm X-Ray System Recalled for Emergency Switch Issue

    Ziehm Imaging Inc is recalling 103 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component.

    Product
    Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0493-2014·2014-01-01

    Biomet Recalls G7 Acetabular Screws Due to Incorrect Diameter Labeling

    Biomet is recalling G7 Acetabular Screws because the labels incorrectly list the diameter as 10.5mm instead of the actual 6.5mm.

    Product
    G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2014·2014-01-01

    Integra Recalls Cranial Access Kits Due to Labeling Discrepancies

    Integra LifeSciences is voluntarily recalling unexpired lots of HITHSP10 Cranial Access Kits because the labeling for included DuraPrep and Monocryl sutures does not align with the kit's intended use.

    Product
    Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2014·2014-01-01

    Abbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination

    Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.

    Product
    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0576-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.

    Product
    Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2014·2014-01-01

    Ziehm Vision RFD C-Arm X-Ray System Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

    Product
    Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0565-2014·2014-01-01

    Ziehm Vision C-Arm X-Ray System Recalled for Emergency Switch Change

    Ziehm Imaging Inc is recalling 54 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

    Product
    Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1147-2014·2014-01-01

    Vega Nutritional Shake Recalled for Chloramphenicol Contamination

    Sequel Naturals is recalling nine lots of Vega All-In-One Nutritional Shake Berry due to trace amounts of chloramphenicol.

    Product
    Vega All-In-One Nutritional Shake Berry. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30 oz./850g, 425g, 38.6g containers.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0575-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states

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