The Recall Desk

Archive

February 2014 recalls

473 recalls were announced in February 2014.

What the numbers show

Critical
14
Severe
98
High
222
Moderate
120
Low
19

Of the 473 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

1–100 of 473

  • SevereNHTSA·14V085000·2014-02-28

    MCI Recalls 2011-2012 D4000 Motorcoaches Due to Fire Risk

    Motor Coach Industries is recalling 2011-2012 D4000 motorcoaches because condensation in the intake manifold may freeze, causing sensor failure that leads to exhaust flames or vehicle fire.

    Product
    MCI — MCI D4000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V083000·2014-02-27

    Blue Bird Recalls School Buses Due to Exhaust Fire Risk

    Blue Bird is recalling 2009-2015 All American school buses because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames that increase the risk of fire or burn injury.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V084000·2014-02-27

    Gillig Low Floor Transit Bus Recall for Engine Fire Risk

    Gillig is recalling 2010-2014 Low Floor transit buses because condensation in the intake manifold may freeze, causing sensor failure and increasing the risk of a vehicle fire.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V077000·2014-02-27

    Forest River Wildcat Recalled for Incorrect Weight Certification Label

    Forest River is recalling 2014 Wildcat recreational vehicles because the certification tag lists an incorrect gross vehicle weight rating, which could lead to overloading and tire failure.

    Product
    FOREST RIVER — FOREST RIVER WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14718·2014-02-27

    Rowe Fine Furniture Recalls Dalton Ottomans Due to Suffocation Risk

    Rowe Fine Furniture is recalling Dalton Ottomans with storage compartments because young children can become entrapped inside, posing a risk of suffocation.

    Product
    Dalton Ottomans with Storage Compartments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14118·2014-02-27

    Mammut Recalls Crevasse Rescue Devices Due to Lock Cam Failure Risk

    Mammut is recalling RescYou crevasse rescue devices because the pull cord lock cam can fail, posing a risk of death and injury during a rescue.

    Product
    Mountain climbing rescue devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V093000·2014-02-27

    Northwest Truck Camper Recall for Door Lock Jamming Hazard

    Northwest Custom Campers is recalling 2006-2012 truck campers because a defect in Fastec door locks may jam the deadbolt, potentially trapping occupants inside.

    Product
    NORTHWEST — NORTHWEST TRUCK CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0995-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2014·2014-02-26

    Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error

    Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.

    Product
    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·017-2014·2014-02-26

    Sun Hing Foods Recalls Canadian Liver Pâté Produced Without Inspection

    Sun Hing Foods is recalling 1,282 pounds of Canadian liver pâté and spread that were not inspected by USDA at the U.S. border.

    Product
    California Firm Recalls Canadian Liver P,tE Products Produced Without Import Inspection
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1000-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0999-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1536-2014·2014-02-26

    StemVida Recalls StemAlive Capsules Due to Undeclared Milk Allergen

    StemVida International is recalling StemAlive 90 Capsules because the product contains undeclared milk, a major food allergen.

    Product
    STEMALIVE, 90 Capsules. The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label. Product labeling reads in part:"STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supp
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1537-2014·2014-02-26

    NOW Foods Recalls Digestive Enzyme Capsules Due to Chloramphenicol Contamination

    NOW Foods is recalling digestive enzyme capsules because they may contain the antibiotic chloramphenicol. The recall covers 31,344 bottles distributed nationwide and in several foreign countries.

    Product
    Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1521-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hatch Valley Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hatch Valley Mild cheese due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hatch Valley Mild 5-5# Z, Product Item Number 1057-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1497-2014·2014-02-26

    El Encanto Recalls Hatch Valley XXXHot Salsa for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hatch Valley XXXHot salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hatch Valley XXXHot 5-5# Z, Product Item Number 1020-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1511-2014·2014-02-26

    El Encanto Recalls Hot Salsa for Possible Listeria Contamination

    El Encanto, Incorporated is recalling GC NO LABEL Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hot 12-13 oz Z salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hot 12-13 oz Z, Product Item Number 1022-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2014·2014-02-26

    Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter

    Merit Medical Systems is recalling custom procedural trays containing 1% Lidocaine HCl injection due to visible particulate matter found in the product container.

    Product
    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1512-2014·2014-02-26

    El Encanto GC Exclusive Hot 5-5# Z Recalled for Listeria Risk

    El Encanto, Incorporated is recalling GC Exclusive Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1520-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Reserve Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Reserve Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1527-2104·2014-02-26

    El Encanto Recalls Bueno GC Strip Hot Due to Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC Strip Hot due to possible Listeria monocytogenes contamination. The product was distributed nationwide, including to military and government consignees.

    Product
    Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1538-2014·2014-02-26

    Comarco Gorgonzola Stuffed Jalapeno Peppers Recalled for Listeria

    Comarco Products is recalling Gorgonzola stuffed jalapeno peppers because they tested positive for Listeria monocytogenes.

    Product
    IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013 24/30 lb bags - 720 lb totes Keep Frozen Bin# Comarco Products 501 Jackson Street, Camden, NJ 08104
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1504-2014·2014-02-26

    El Encanto Recalls SuperHot Product Due to Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hatch Valley Blakes SuperHot due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hatch Valley Blakes SuperHot 5-5# Z, Product Item Number 1028-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1530-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hot salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hot 2-12.5# Z, Product Item Number 1081-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1535-2014·2014-02-26

    Kinnikinnick Gluten-Free Waffles Recalled for Undeclared Milk Allergen

    DPI Specialty Foods is recalling Kinnikinnick gluten-free waffles because they may contain undeclared milk, despite labeling indicating the product is dairy-free.

    Product
    Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. DPI item # 55844.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1507-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hot 6-56oz Z salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hot 6-56oz Z, Product Item Number 1042-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1515-2014·2014-02-26

    El Encanto Recalls Hatch Valley Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Hatch Valley Hot salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1508-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1518-2014·2014-02-26

    El Encanto Recalls Mild Cheese Due to Listeria Risk

    El Encanto, Incorporated is recalling GC NO LABEL Mild 5-5# Z cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    GC NO LABEL Mild 5-5# Z, Product Item Number 1057-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2014·2014-02-26

    El Encanto Autumn Roast Hot Salsa Recalled for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Autumn Roast Hot salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14116·2014-02-26

    STX Recalls Shield Throat Protector Due to Laceration Hazard

    STX is recalling about 4,000 Shield throat protectors because the device can crack or break when struck by a lacrosse ball, posing a laceration hazard to the user's neck.

    Product
    STX Shield throat protector
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1528-2014·2014-02-26

    El Encanto Recalls Bueno GC Whole Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC Whole Mild cheese due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC Whole Mild 2-12.5# Z, Product Item Number 1073-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2014·2014-02-26

    El Encanto Recalls Bueno GC NM XHot for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM XHot due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM XHot 12-13 oz Z, Product Item Number 1021-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1503-2014·2014-02-26

    El Encanto Autumn Roast Hot Chili Recalled for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hatch Valley Autumn Roast Hot due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hatch Valley Autumn Roast Hot 12-13 oz Z, Product Item Number 1026-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2014·2014-02-26

    B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage

    B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.

    Product
    SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1519-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1505-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hot 28oz salsa due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hot 28oz, Product Item Number 1032-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1524-2014·2014-02-26

    El Encanto Autumn Roast Hot Pepper Recall for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Autumn Roast Hot peppers due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1516-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Hot 5-5# Z, Product Item Number 1056-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1531-2014·2014-02-26

    El Encanto Autumn Roast Strip Beef Recalled for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC Autumn Roast Strip Medium beef due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1510-2014·2014-02-26

    El Encanto GC Medium 5-5# Z Recalled for Listeria Risk

    El Encanto, Incorporated is recalling GC Medium 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1539-2014·2014-02-26

    Mid Pac Foods Recalls Char Sui Sauce for Undeclared Wheat

    Mid Pac Foods is recalling Char Sui sauce because it contains wheat, a major allergen, that is not listed on the label.

    Product
    Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by Mid Pac Foods, Inc. Honolulu, HI.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1491-2014·2014-02-26

    El Encanto Autumn Roast Coffee Recalled for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Autumn Roast Exclusive Hot coffee due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Autumn Roast Exclusive Hot 5-5# Z, Product Item Number 1015-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2014·2014-02-26

    Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues

    Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    HGP II ACETABULAR CUP MOD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2014·2014-02-26

    Biosense Webster Recalls CartoUnivu Module for Map Misalignment

    Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.

    Product
    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLU
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-1541-2014·2014-02-26

    YoungYou Recalls Mega Slim Herbal Appetite Management Due to DMAA

    YoungYou International is voluntarily recalling Mega Slim Herbal Appetite Management capsules because they contain DMAA.

    Product
    Mega Slim Herbal Appetite Management, 30 Capsules Bottle. Product labeling reads in part:"MEGASLIM Herbal Appetite Management***30 Capsules***YoungYou Weight Loss Center***MegaSim Propriety Blend 590 mg, Garcinia Cambogia Extract, Green Tea, Aloe Ferox, L-Carnitine, Caralluma
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1526-2014·2014-02-26

    El Encanto Recalls Bueno GC Strip Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC Strip Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC Strip Mild 2-12.5# Z, Product Item Number 1071-4. Packaged in double-poly bags.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2014·2014-02-26

    Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error

    Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.

    Product
    Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2014·2014-02-26

    El Encanto Organic Mild Cheese Recalled for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC Organic Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC Organic Mild 12-13 oz Z, Product item Number 1023-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2014·2014-02-26

    El Encanto Recalls Bueno Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1514-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Reserve Hot Salsa for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Reserve Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Reserve Hot 5-5# Z, Product Item Number 1056-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2014·2014-02-26

    Perrigo Recalls Orbit Soft Infusion Sets Due to Connector Incompatibility

    Perrigo Diabetes Care is recalling Orbit soft Infusion sets because the luer-lock connectors are incompatible with standard infusion pumps.

    Product
    Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1506-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2014·2014-02-26

    GE Healthcare Recalls Dash Patient Monitors Due to Network and ECG Issues

    GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors and Dash Port 2 Docking Stations due to network communication failures and distorted ECG waveforms.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1522-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1523-2014·2014-02-26

    El Encanto Autumn Roast Recalled for Possible Listeria Contamination

    El Encanto, Incorporated is recalling GC Autumn Roast Hot due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    GC Autumn Roast NO LABEL Hot 5-5# Z, Product Item Number 1062-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1534-2014·2014-02-26

    Cal-Fresh Recalls Kinnikinnick Waffles for Undeclared Milk

    Cal-Fresh Produce is recalling Kinnikinnick Original Homestyle Waffles due to undeclared milk. The recall affects 117 units distributed in California.

    Product
    Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box UPC: 62013300198 1
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1509-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Exclusive XHot for Listeria Risk

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Exclusive XHot due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1533-2014·2014-02-26

    El Encanto Recalls Bueno GC 1.5 Hot Salsa for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC 1.5 Hot 5-5# Z salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1517-2014·2014-02-26

    El Encanto Recalls Bueno GC Exclusive Shot Due to Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC Exclusive Shot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC Exclusive Shot 5-5# Z, Product Item Number 1056-8. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2014·2014-02-26

    Zimmer Recalls ZIMTRON 6 DEG 22 Heads Due to Packaging Validation Issues

    Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    ZIMTRON 6 DEG 22 HEADS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1490-2014·2014-02-26

    El Encanto Recalls BACA'S GC Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling BACA'S GC Hot 12-13oz Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1525-2014·2014-02-26

    El Encanto Autumn Roast Hot Pepper Recall for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Autumn Roast Hot peppers due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2014·2014-02-26

    Standing Company Recalls Superstand Wheelchairs Due to Flex Shaft Fracture Risk

    The Standing Company is recalling approximately 119 Superstand stand-up wheelchairs because the flex shaft may fracture if bent repeatedly or beyond 90 degrees.

    Product
    Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2014·2014-02-26

    Siemens Prisma 2K Pediatric Hearing Aid Battery Compartment Recall

    Siemens is recalling Prisma 2K hearing aids because the battery compartment may open under unintended use, posing a risk to infants and children.

    Product
    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1529-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hatch Valley Mild Cheese

    El Encanto, Incorporated is recalling specific lots of Bueno GC NM Hatch Valley Mild cheese due to possible Listeria monocytogenes contamination.

    Product
    Bueno GC NM Hatch Valley Mild 2-12.5# Z, Product Item Number 1077-6. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Hot Salsa Due to Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Hot 5-5# Z salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1532-2014·2014-02-26

    El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk

    El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Bueno GC NM Mild 2-12.5# Z, Product Item Number 1093-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 2 units of 12.5 lbs. each per case, totaling 25 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2014·2014-02-26

    Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles

    Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.

    Product
    Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2014·2014-02-26

    GE Healthcare Recalls PET Discovery Systems Due to Scatter Overcorrection

    GE Healthcare is recalling PET Discovery 600, 610, 690, and 710 systems due to a potential safety issue with the List Mode Replay feature causing scatter overcorrection.

    Product
    GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy b
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0998-2014·2014-02-26

    Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.

    Product
    Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2014·2014-02-26

    Elekta Synergy XVI Radiation Therapy System Recalled for Collision Risk

    Elekta, Inc. is recalling 312 Synergy XVI radiation therapy systems due to a potential collision risk when used with external beam shaping devices.

    Product
    Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2014·2014-02-26

    Integra CUSA Excel CEM Nosecone Recalled for Sticking Button

    Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.

    Product
    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1044-2014·2014-02-26

    Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1027-2014·2014-02-26

    Zimmer Recalls Pressfit Femoral Stems Due to Packaging Validation Issues

    Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    PRESSFIT FEM ST FX 16 X 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1028-2014·2014-02-26

    Zimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues

    Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    VERSYS HERITAGE FEM STEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0983-2014·2014-02-26

    Invivo Expression Information Portal Recalled for Audio Failure

    Invivo Corporation is recalling the Expression Information Portal (Model IP5) because the device may fail to produce audio upon power up.

    Product
    Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1058-2014·2014-02-26

    BioHorizons Recalls Dental Implants with Incorrect Length Labeling

    BioHorizons is recalling 119 units of dental implants labeled as 10.5mm but actually measuring 12mm. The recall addresses a labeling error regarding the product's physical dimensions.

    Product
    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2014·2014-02-26

    Zimmer Recalls Orthopedic Screws Due to Packaging Validation Deficiencies

    Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1003-2014·2014-02-26

    Zimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues

    Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1011-2014·2014-02-26

    Zimmer Recalls Humeral Intramedullary Nails Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 humeral intramedullary nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2014·2014-02-26

    Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

    Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2014·2014-02-26

    Zimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations

    Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1540-2014·2014-02-26

    Abbott Nutrition Recalls Similac Human Milk Fortifier Powder Packets

    Abbott Nutrition is recalling Similac Human Milk Fortifier Powder packets in Canada due to incomplete seals that may allow air entry, causing oxidation or powder leakage.

    Product
    Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0986-2014·2014-02-26

    Synthes 3.2 mm Guide Wire Recalled for Incorrect Raw Material Labeling

    Synthes, Inc. is recalling 3.2 mm Guide Wires because the label lists an incorrect raw material. The recall covers units distributed in the USA, Canada, and Switzerland.

    Product
    Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1034-2014·2014-02-26

    Zimmer Recalls 6 Degree COCR Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 6 Degree COCR Femoral Heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    6 DEGREE COCR FEM HEAD 36
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2014·2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1478-2014·2014-02-26

    Dried Tapioca Pearls Recalled for Unapproved and Undeclared Colors

    New Japan International, Inc. is recalling dried tapioca pearls containing unapproved and undeclared colors. The product was distributed in ten states.

    Product
    Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1036-2014·2014-02-26

    Zimmer Recalls CPT Degree Taper and Femoral HD Medical Devices

    Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.

    Product
    CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2014·2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

    Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2014·2014-02-26

    Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1037-2014·2014-02-26

    Zimmer Recalls FEM HD ION Hip Implants Due to Packaging Validation Issues

    Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    FEM HD ION (various sizes)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2014·2014-02-26

    Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues

    Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2014·2014-02-26

    Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer

    Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.

    Product
    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1001-2014·2014-02-26

    Zimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues

    Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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