The Recall Desk

Archive

October 2012 recalls

969 recalls were announced in October 2012.

What the numbers show

Critical
242
Severe
210
High
389
Moderate
113
Low
15

Of the 969 recalls this month scored against our rubric, 25% are Critical, 22% are Severe.

601–700 of 969

  • CriticalFDA (Food)·F-0027-2013·2012-10-17

    GM Produce Sales Recalls Marathon Brand Mangos Due to Salmonella Risk

    GM Produce Sales is voluntarily recalling 4,994 cartons of Marathon brand mangos from Mexico due to potential Salmonella gaminara contamination.

    Product
    Marathon brand- 4 kilo boxes, label on the mango says "MARATHON...PRODUCE OF MEXICO", 952 ctns. of number 6 mangos, 714 ctns. of number 7's, 1186 ctns. of number 8's, 952 ctns. of number 9's, 714 ctns. of number 10's, 476 ctns. of number 12's.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0026-2013·2012-10-17

    Fresh Express Romaine Lettuce Recalled for Listeria Monocytogenes

    Fresh Express is recalling 9 oz. bags of Romaine lettuce due to a positive Listeria Monocytogenes test result.

    Product
    Fresh Express Leafy Green Romaine; Crunchy Romaine Lettuce & Tender Green Leaf Lettuce 9 oz. bag, Keep refrigerated, no preservatives. UPC 71279-26112. Fresh Express Incorporated Salinas, CA.
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0038-2013·2012-10-17

    3fish Maryland Crab Cake Recalled for Listeria-Contaminated Onions

    3fish Inc. is recalling Maryland Crab Cake Bulk (fresh) because it was manufactured with diced onions contaminated with Listeria monocytogenes.

    Product
    Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0082-2013·2012-10-17

    United Salad Company Recalls Mango Products for Salmonella Contamination

    United Salad Company is recalling diced, peeled, and speared mango products due to potential Salmonella contamination. The products were distributed to customers in five western states.

    Product
    Fruit Mango diced, peeled halves or spears 1) United Salad Co. brand Mango Diced 5 lb no UPC 2) United Salad Co brand Mango Peeled Halves 1 lb not UPC 3) Garden Highway Plant Code: P-002 Mango Spears 24 oz UPC 826766-214068
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0037-2013·2012-10-17

    Cut Fruit Express Recalls Melon Medley Chunk Due to Salmonella Risk

    Cut Fruit Express is recalling H. Brooks Melon Medley Chunk because processed cantaloupe in the product tested positive for Salmonella.

    Product
    CANTALOUPE, HONEYDEW, WATERMELON: Festival Foods-Best Of The Season 37461 H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3. H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3.. Distributed b
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0030-2013·2012-10-17

    Cut Fruit Express Recalls Cantaloupe Products Due to Salmonella Risk

    Cut Fruit Express is recalling various cantaloupe products because the supplier recalled the raw cantaloupe after a positive Salmonella sample.

    Product
    CANTALOUPE: UPPER LAKES Foods 142901 CANTALOUPE CHUNK 2/3# UPPER LAKES Foods 142800 CANTALOUPE HALVED/PEELED 2/5# & 5# USF 4259982 CANTALOUPE DICED 1/2" X 1/2" 2/5# CCP USF 4384418 CANTALOUPE CHUNKS 25# USF 8138646 CANTALOUPE CHUNK 4/5# USF 5985015 CANTALO
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0039-2013·2012-10-17

    3fish Inc. Recalls Charl Crab Cake Bulk Due to Listeria Contamination

    3fish Inc. is recalling Charl Crab Cake Bulk (fresh) because it was manufactured with diced onions contaminated with Listeria monocytogenes.

    Product
    Charl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0097-2013·2012-10-17

    Manna Organics Recalls Soybean Sprouts Due to Listeria Risk

    Manna Organics Inc. is recalling SooNyeoWon Soybean Sprouts in 5 lb, 10 lb, and 16 oz packages due to potential Listeria monocytogenes contamination.

    Product
    SooNyeoWon Soybean Sprouts (5 lbs., 10 lbs., and 16-ounce packages - all packaged in plastic bags). 16-oz bag UPC 0 28346 07121 8; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0104-2013·2012-10-17

    Manna Organics Soon Tofu Recalled for Potential Listeria Contamination

    Manna Organics Inc. is recalling Soon Tofu due to potential contamination with Listeria monocytogenes. The product was distributed in ten states.

    Product
    Soon Tofu, 30-pieces packaged in large, white, plastic bucket. Manna Organics Inc. Newark, NJ
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0101-2013·2012-10-17

    Manna Organics Recalls Soft Tofu for Potential Listeria Contamination

    Manna Organics is recalling specific lots of Soft Tofu due to potential Listeria monocytogenes contamination. Consumers in ten states should check their refrigerators.

    Product
    SooNyeoWon and Jinga brand Soft Tofu 16 oz. in square, plastic containers, UPC 0 28346 07814 9 (SooNyeoWon). Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·12V507000·2012-10-17

    Navistar Recalls 2013 International Trucks Due to Steering Wheel Weld Defect

    Navistar is recalling 2013 International LoneStar, ProStar, and WorkStar trucks because the steering wheel may not be fully welded to its hub, risking loss of vehicle control.

    Product
    INTERNATIONAL — INTERNATIONAL WORKSTAR, LONESTAR, PROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0033-2013·2012-10-17

    Cut Fruit Express Recalls Mixed Fruit Bowls Due to Salmonella Risk

    Cut Fruit Express is recalling mixed fruit bowls containing cantaloupe, honeydew, grape, pineapple, and strawberry due to a positive Salmonella sample.

    Product
    CANTALOUPE, HONEYDEW, GRAPE, PINEAPPLE, STRAWBERRY: Festival Foods-Best Of The Season 32299 H. Brooks FRUIT BOWL CHPGS 3# Net Wt 48 oz (1362g) K280 2 per case UPC# 0 3823232299 7. Distributed by H.Brooks & Co Mpls MN 55112
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0028-2013·2012-10-17

    Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns

    Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.

    Product
    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0027-2013·2012-10-17

    OrthoHelix 3.8mm Cannulated Hex Drivers Recalled for Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.

    Product
    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0103-2013·2012-10-17

    Manna Organics Healthy Tofu Recalled for Listeria Contamination Risk

    Manna Organics Inc. is recalling Healthy Tofu products due to potential Listeria monocytogenes contamination. The recall affects units distributed across ten states.

    Product
    Labeled in Korean as Healthy Tofu, 5-pieces and 10 pieces, UPC 028346091292. Manna Organics Inc. Newark, NJ.
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0053-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0064-2013·2012-10-17

    Springside Monterey Jack Habanero Cheese Recalled for Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling Monterey Jack Habanero Cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Habanero Cheese, 55-0172, V3, August 21, 2012,
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0046-2013·2012-10-17

    3fish Inc. Recalls Stuffed Tilapia Due to Listeria Contamination

    3fish Inc. is recalling Harris Teeter Stuffed Tilapia 8ct (Fresh) because it was manufactured with diced onions contaminated with Listeria monocytogenes.

    Product
    Harris Teeter, Stuffed Tilapia 8ct (Fresh)
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·12E046000·2012-10-17

    Toyota Recalls FJ Cruiser Brake Kits Due to Fluid Leak Risk

    Toyota is recalling specific TRD brake kits for 2007-2012 FJ Cruisers because the brake tube may be damaged by wheel weights, causing fluid leaks and increased stopping distances.

    Product
    TOYOTA — TOYOTA FJ CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0085-2013·2012-10-17

    Kroger Fresh Selections Tender Spinach Recalled for Listeria

    Kroger is recalling Fresh Selections Tender Spinach after the Ohio Department of Agriculture detected Listeria monocytogenes in the product.

    Product
    FRESH SELECTIONS by Kroger" Tender Spinach NET WT 10 OZ (283g) BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 INGREDIENTS: SPINACH DISTRIBUTED BY THE KROGER COM. CINCINNATI OHIO 45202
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0098-2013·2012-10-17

    Manna Organics Firm Tofu Recalled for Listeria Contamination Risk

    Manna Organics is recalling SooNyeoWon and Jinga brand Firm Tofu due to potential Listeria monocytogenes contamination. The product was distributed in ten states.

    Product
    SooNyeoWon and Jinga brand Firm Tofu; Net Wt. 16 oz., in square white plastic container, UPC 0 28346 07812 5 and 0 28346 09112 4, respectively. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0026-2013·2012-10-17

    OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage

    Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.

    Product
    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0036-2013·2012-10-17

    Cut Fruit Express Recalls Cantaloupe and Honeydew Due to Salmonella

    Cut Fruit Express, Inc. is recalling processed cantaloupe and honeydew products due to a positive Salmonella sample found by the supplier.

    Product
    CANTALOUPE, HONEYDEW: Festival Foods-Best Of The Season 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. H.Brooks 46981 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. Distributed by H. Broo
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0017-2013·2012-10-17

    Accutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function

    Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.

    Product
    Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0078-2013·2012-10-17

    Marte Frescolina Ricotta Salata Recalled for Listeria monocytogenes Contamination

    Forever Cheese Inc is recalling Frescolina Ricotta Salata cheese found positive for Listeria monocytogenes during state and federal sampling.

    Product
    Marte brand Frescolina Ricotta Salata. Matured and packed by: Fattorie Chiarappa SRL VIA Dell'ulvio, 5 Conversano (BA) - Italy. --- Product is vacuum packaged and is labeled with a round label. Product may also be cut into smaller wedges, but will still have the same Frescolina R
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0035-2013·2012-10-17

    Cut Fruit Express Recalls Cantaloupe, Pineapple, and Watermelon Mix

    Cut Fruit Express, Inc. is recalling 15-ounce fruit mix containers due to a positive Salmonella sample found in processed cantaloupe.

    Product
    CANTALOUPE, PINEAPPLE AND WATERMELON: H.Brooks & Company 33531 FRUIT MIX CPW SPEARS 15oz (425g) 4 per case UPC# 0 3823233531 7. Distributed by H. Brooks & Co Mpls. MN55112.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0040-2013·2012-10-17

    3fish Inc. Recalls Crab Stuffing Bucket Due to Listeria Contamination

    3fish Inc. is recalling 5 lb tubs of Crab Stuffing Bucket because they were manufactured with diced onions contaminated with Listeria monocytogenes.

    Product
    Crab Stuffing  Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0049-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions

    Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.

    Product
    Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Food)·F-0093-2013·2012-10-17

    G.O. Fresh Recalls Cut Cantaloupe Items Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut fruit items containing cantaloupe due to potential Salmonella contamination linked to a DFI Marketing recall.

    Product
    SYSCO Imperial 9498072 FRUIT W/GOLD PINEAPPLE KIT 4/1.5# 130250 BEST BY 9/16/12, UPC# 1007 4865871287.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0032-2013·2012-10-17

    Cut Fruit Express Recalls Melon Mix Slices Due to Salmonella Risk

    Cut Fruit Express is recalling melon mix slices because the supplier recalled processed cantaloupe after a positive Salmonella sample.

    Product
    CANTALOUPE, WATERMELON, HONEY DEW, RED GRAPES: Festival Foods-Best Of The Season 30787 H.Brooks Melon Mix Slices Net Wt. 12 oz. (340g) 3 units per case 331 UPC# 0 3823230787 1.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·12V504000·2012-10-17

    BMW Recalls 7-Series Vehicles for Door Latch Software Defect

    BMW is recalling 2005-2007 7-Series vehicles because a software issue may cause doors to open unexpectedly while driving, posing a risk of occupant ejection or injury.

    Product
    BMW — BMW 760I, 750I, 745I, 750LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0050-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall

    Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.

    Product
    Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0051-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0092-2013·2012-10-17

    G.O. Fresh Recalls Cantaloupe Fruit Variety Garden-to-Go Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut fruit items containing cantaloupe due to potential Salmonella contamination linked to a DFI Marketing recall.

    Product
    SYSCO Imperial 5370204 30/4.5 OZ/ ,30# FRUIT VARIETY GARDEN-TO-GO 130249 & 130250 BEST BY 9/15/12 & 9/16/12 .
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0073-2013·2012-10-17

    Springside Cheese Recalls Morel & Leek Monterey Jack Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Morel & Leek Monterey Jack cheese produced between August 21 and September 1, 2012, due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Morel & Leek Monterey Jack, 55-0172, V3, August 28, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0052-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0072-2013·2012-10-17

    Springside Cheese Recalls Bacon Colby Cheese Due to Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling Bacon Colby Cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Bacon Colby Cheese, 55-0172, V3, August 27, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0054-2013·2012-10-17

    Kardium Recalls TORQ Sternal Closure Devices Due to Metal Part Risk

    Kardium is recalling 480 units of the TORQ Sternal Closure Device because a metal part may dislodge during use.

    Product
    TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0070-2013·2012-10-17

    Springside Cheese Recalls Reduced Fat Caraway Farmers Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Reduced Fat Caraway Farmers cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Reduced Fat Caraway Farmers, 55-0172, V2, August 21, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0023-2013·2012-10-17

    BioMérieux PREVI Isola System Recall for False Negative Results

    BioMérieux is recalling PREVI Isola Systems because they may fail to dispense specimens, leading to false negative microbiological test results.

    Product
    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0057-2013·2012-10-17

    Springside Cheese Recalls Cheddar for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Blue Cheese Color Cheddar produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Blue Cheese Color Cheddar, 55-0172, V2, August 24, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0077-2013·2012-10-17

    Springside Cheese Recalls White Cheddar Due to Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling rBGH Free White Cheddar produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, rBGH Free White Cheddar, 55-0172, V32 August 22, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0061-2013·2012-10-17

    Springside Cheese Recalls Monterey Jack Chipotle Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Monterey Jack Chipotle cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Chipotle Cheese, 55-0172, V3, August 21, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0055-2013·2012-10-17

    Springside Cheese Recalls Cheddar for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling cheddar cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Color Cheddar, 55-0172, V1, August 21, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0068-2013·2012-10-17

    Springside Cheese Recalls White Cheddar Midgets Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling specific White Cheddar Midgets produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Black & Green Olive White Cheddar Midget, 55-0172, V3, August 22, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0088-2013·2012-10-17

    G.O. Fresh Recalls Cantaloupe Fruit Variety Chunk Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut fruit items containing cantaloupe due to potential Salmonella contamination linked to a supplier recall.

    Product
    SYSCO Imperial 2232734 4/5# FRUIT VARIETY CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865593493.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0071-2013·2012-10-17

    Springside Cheese Recalls Colby Cheese Due to Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Colby cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Colby Cheese, 55-0172, V3, August 27, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0056-2013·2012-10-17

    Springside Cheese Recalls Black Pepper Cheddar Due to Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling specific lots of Black Pepper Color Cheddar cheese produced in late August and early September 2012 due to potential Giardia contamination.

    Product
    Springside Cheese, Black Pepper Color Cheddar, 55-0172, V2, August 24, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0069-2013·2012-10-17

    Springside Cheese Recalls Reduced Fat Farmers Cheese Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Reduced Fat Farmers Cheese produced in late August and early September 2012 due to potential Giardia contamination.

    Product
    Springside Cheese, Reduced Fat Farmers Cheese, 55-0172, V2, August 21, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0086-2013·2012-10-17

    G.O. Fresh Recalls Cut Cantaloupe Due to Potential Salmonella Contamination

    G.O. Fresh is voluntarily recalling specific cut cantaloupe products due to potential Salmonella contamination linked to a supplier recall.

    Product
    Cut Cantaloupe: G.O Fresh: 0379729 4/5# CANTALOUPE CHUNKS (PACKER) 130250 BEST BY 9/16/12. SYSCO Imperial: 2229268 4/5# MELON CANTALOUPE 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865593455. SYSCO Imperial: 6520878 1/5# PAIL CANTALOUPE CHUNK 3/4" 13024
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0094-2013·2012-10-17

    G.O. Fresh Recalls Cantaloupe Mix Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut melon mix products containing cantaloupe due to potential Salmonella contamination.

    Product
    SYSCO Imperial 1/5# PAIL MELON MIX HONEY-CANT W/ GRAPE 7225071 1/5#MELON W/GRAPE 130249 BEST BY 9/15/12, UPC# 0007 4865448475.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0065-2013·2012-10-17

    Springside Monterey Jack Jalapeno Cheese Recalled for Potential Giardia Contamination

    Springside Cheese Corp. is voluntarily recalling Monterey Jack Jalapeno Cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Jalapeno Cheese, 55-0172, V3, August 21, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0021-2013·2012-10-17

    Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers

    Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test results.

    Product
    Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0024-2013·2012-10-17

    Neera's Tikka Curry Sauce Recalled for Undeclared Milk and Soy

    Cinnabar Specialty Foods is recalling Neera's Tikka Curry Simmering Sauce because it contains undeclared milk and soy ingredients.

    Product
    Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case. Product labeling reads in part:" NEERA'S TIKKA CURRY Rich and Creamy All Natural Simmering Sauce***Just add meat, fish or vegetables!***16
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0076-2013·2012-10-17

    Springside Monterey Jack Salsa Cheese Recalled for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Monterey Jack Salsa Cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Salsa Cheese, 55-0172, V3, August 28, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0060-2013·2012-10-17

    Springside Monterey Jack Cheese Recalled for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Monterey Jack Caribbean Red Hot cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Caribbean Red Hot , 55-0172, V3, August 28, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0013-2013·2012-10-17

    Baxter Buretrol Solution Set Recalled Due to Ball-Valve Malfunction

    Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.

    Product
    Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recall

    Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring functio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0102-2013·2012-10-17

    Manna Organics Recalls Silken Tofu Due to Listeria Risk

    Manna Organics Inc. is recalling 14 oz. containers of SooNyeoWon Silken Tofu because the product has the potential to be contaminated with Listeria monocytogenes.

    Product
    SooNyeoWon Silken Tofu; 14 oz. plastic container, UPC 0 28346 09113 1. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0020-2013·2012-10-17

    Accutron Newport Portable Analgesia Gas Machine Recalled for Flowmeter Defect

    Accutron is recalling 220 Newport Portable Analgesia Gas Machines because the flowmeter functions incorrectly when nitrous gas flows without oxygen.

    Product
    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0074-2013·2012-10-17

    Springside Monterey Jack Cheese Recalled for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Monterey Jack Peppercorn Ranch cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Peppercorn Ranch , 55-0172, V3, August 28, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0075-2013·2012-10-17

    Springside Cheese Recalls Monterey Jack Roasted Red Pepper Cheese Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Monterey Jack Roasted Red Pepper Cheese produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Roasted Red Pepper Cheese, 55-0172, V3, August 28, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0014-2013·2012-10-17

    Baxter Recalls Clearlink Buretrol Solution Sets Due to Valve Malfunction

    Baxter Healthcare is recalling Clearlink Buretrol Solution Sets because the ball-valve feature may fail, allowing air to enter the tubing.

    Product
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2013·2012-10-17

    3M Recalls Steri-Vac Gas Sterilizers Due to Electrical Grounding Defect

    3M is recalling Steri-Vac 5XL and 8XL gas sterilizers because the electrical grounding mechanism did not meet safety standards.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0053-2013·2012-10-17

    Dae Han Tofu Soya Select Stir Fried Tofu Recalled for Labeling Error

    Pacific Northwest Tofu, LLC is recalling Dae Han Tofu Soya Select Stir Fried Tofu because soy was partially declared on the label due to a printing error.

    Product
    Stir Fried Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Stir Fried Tofu has the UPC 0 31499 003283.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0091-2013·2012-10-17

    G.O. Fresh Recalls Cantaloupe Fruit Mix Chunks Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut fruit mix chunks containing cantaloupe due to potential Salmonella contamination linked to a DFI Marketing recall.

    Product
    SYSCO Imperial 6520795 1/5# FRUIT MIX CHUNKS 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865393314.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0046-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0054-2013·2012-10-17

    Springside Cheese Recalls Color Cheddar Curds Due to Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling Color Cheddar Cheese Curds produced between August 21 and September 1, 2012, due to potential Giardia contamination from an employee illness.

    Product
    Color Cheddar Cheese Curds: Springside Cheese, Color Curd, 55-0172, V1, August 27, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0015-2013·2012-10-17

    Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction

    Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.

    Product
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0087-2013·2012-10-17

    G.O. Fresh Recalls Mixed Fruit Products Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific mixed fruit products containing cantaloupe due to potential Salmonella contamination.

    Product
    Mixed Fruit w/ Grapes: SYSCO Imperial 1210321 4/5# FRUIT MIX CHUNK W/GRAPES 130250 BEST BY 9/16/12. SYSCO Imperial 2665156 4/5# MIX MELON W/ REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865599914. SYSCO Imperial 3278165 1/5# FRUIT MIX CHUNK WI/GRAPE 130
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0090-2013·2012-10-17

    G.O. Fresh Recalls Cut Fruit Mix Due to Salmonella Risk

    G.O. Fresh is voluntarily recalling specific cut fruit mix items containing cantaloupe due to potential Salmonella contamination.

    Product
    SYSCO Imperial 4835718 30/4.5 OZ FRUIT MIX CANT/PINE/REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12. SYSCO Imperial 7068657 4/5# FRUIT MIX CANT/PINE/RED GRAPE 130250 BEST BY 9/16/12.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0025-2013·2012-10-17

    Advanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators

    Advanced Neuromodulation Systems is recalling 56 Eon Mini Implantable Pulse Generators manufactured in April 2012 due to a potential internal battery contact issue that could cause painful stimulation surges.

    Product
    The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0067-2013·2012-10-17

    Springside Cheese Recalls Maple White Cheddar Due to Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling Maple White Cheddar produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Maple White Cheddar, 55-0172, V3, August 22, 2012.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0058-2013·2012-10-17

    Springside Cheese Recalls Cheddar and Horseradish Varieties Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling specific cheddar and horseradish cheeses produced in late August and early September 2012 due to potential Giardia contamination.

    Product
    Springside Cheese, Color Cheddar Horseradish Cheese, 55-0172, V2, August 24, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0066-2013·2012-10-17

    Springside Cheese Recalls White Cheddar Curds Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling White Cheddar Cheese Curds produced in late August and early September 2012 due to potential Giardia contamination from an employee illness.

    Product
    White Cheddar Cheese Curds: Springside Cheese, White Curds, 55-0172, V2, August 22, 2012, NET WEIGHT___.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0031-2013·2012-10-17

    Winco Recalls Caremor Cliner Patient Recliner Chairs Due to Frame Defect

    Winco Mfg. is recalling Caremor Cliner recliner chairs because a back frame failed to snap properly onto the chair frame.

    Product
    Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding dura
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·12V515000·2012-10-17

    New Flyer Recalls 2010 Transit Buses Due to Weak Emergency Window Handles

    New Flyer is recalling 2010 GE35LFR and GE40LFR transit buses because emergency egress window handles may break before releasing the latch, potentially trapping passengers.

    Product
    NEW FLYER — NEW FLYER GE40LFR, GE35LFR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0032-2013·2012-10-17

    Winco Recalls Caremor Cliner Patient Recliners Due to Frame Defect

    Winco Mfg. is recalling Caremor Cliner patient recliners because a back frame may not snap properly onto the chair frame.

    Product
    Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of opera
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0047-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0063-2013·2012-10-17

    Springside Monterey Jack Dill Cheese Recalled for Giardia Contamination Risk

    Springside Cheese Corp is voluntarily recalling Monterey Jack Dill Cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Monterey Jack Dill Cheese, 55-0172, V3, August 21, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0062-2013·2012-10-17

    Springside Cheese Recalls Cranberry Monterey Jack Due to Giardia Risk

    Springside Cheese Corp is voluntarily recalling Cranberry Monterey Jack cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Cranberry Monterey Jack Cheese, 55-0172, V3, August 28, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0081-2013·2012-10-17

    United Salad Company Recalls Fruit Medley Products Due to Salmonella Risk

    United Salad Company is recalling specific fruit medley products because the mangos used may be contaminated with Salmonella.

    Product
    Fruit Medley - 1) Zupan's brand Island Medley 12 oz UPC 92504723497 2) Mary's Select brand Island Fruit Medley - 12 oz UPC 9250473497 3) Mary's Select brand Fruit Mix Ensalada - 12 oz UPC 9250473216 4) Trader Joe's Plant Code: P-002 brand - Tropical Fruit Medley - 1 lb UPC 00
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0036-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error

    Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring func
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0059-2013·2012-10-17

    Springside Cheese Recalls Cheddar for Potential Giardia Contamination

    Springside Cheese Corp is voluntarily recalling Color Cheddar Tomato Basil cheese produced in August and September 2012 due to potential Giardia contamination from an employee illness.

    Product
    Springside Cheese, Color Cheddar Tomato Basil , 55-0172, V1, August 21, 2012,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0012-2013·2012-10-17

    Baxter Buretrol Solution Set Recalled for Potential Air Inflow

    Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.

    Product
    Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2013·2012-10-17

    Medtronic Premier Anterior Cervical Plate Screw Block Recall

    Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.

    Product
    PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2013·2012-10-17

    Accutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect

    Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.

    Product
    Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0083-2013·2012-10-17

    United Salad Company Recalls Mango Salsa Due to Salmonella Risk

    United Salad Company is recalling specific mango salsa products because the mangos used may be contaminated with Salmonella. The products were distributed to wholesale and retail customers in five western states.

    Product
    Mango Salsa 1) Garden Highway Plant Code: P-002 brand Mango Salsa 9 oz UPC 826766-422005 2) Mary's Select brand Tropical Salsa 16 oz UPC 9250474578 3) Mary's Select brand Tropical Salsa 16 oz UPC 9250474569 4) Garden Highway Plant Code: P-002 brand Salsa Tropical Fresh 11
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0034-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2013·2012-10-17

    IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Ass
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0051-2013·2012-10-17

    Pacific Northwest Tofu Recalls Hot & Spicy Tofu Due to Labeling Error

    Pacific Northwest Tofu, LLC is recalling 10 packages of Hot & Spicy Tofu because the ingredient list is cut off, partially declaring wheat or sesame seed oil.

    Product
    Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Hot & Spicy Tofu has the UPC 0 34199 719191.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0106-2013·2012-10-17

    Mothers' Milk Bank at Austin Recalls Pasteurized Human Milk Batches

    Mothers' Milk Bank at Austin is recalling 22 bottles of pasteurized human milk due to the potential presence of foreign materials.

    Product
    Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-007-2013·2012-10-17

    Paddock Recalls Moexipril HCl Tablets Due to Dissolution Failure

    Paddock Laboratories is recalling one lot of Moexipril HCl Tablets 7.5mg due to a dissolution failure found during routine stability testing.

    Product
    Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-006-2013·2012-10-17

    Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues

    Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.

    Product
    Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0055-2013·2012-10-17

    ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling

    ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Product
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0043-2013·2012-10-17

    IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0107-2013·2012-10-17

    Mothers' Milk Bank at Austin Recalls Pasteurized Human Milk

    Mothers' Milk Bank at Austin is recalling 52 bottles of pasteurized human milk in Texas due to the potential presence of foreign materials.

    Product
    Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22, Protein: 1.0 g/dl.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0052-2013·2012-10-17

    Pacific Northwest Tofu Recalls Teriyaki Tofu for Labeling Error

    Pacific Northwest Tofu, LLC is recalling 32 packages of Dae Han Tofu Soya Select Teriyaki Tofu because the soy ingredient declaration is partially cut off on the label.

    Product
    Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The Teriyaki Tofu has the UPC 0 34199 718965.
    Category
    Food
    Distribution
    1 state

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