The Recall Desk

Archive

May 2014 recalls

394 recalls were announced in May 2014.

What the numbers show

Critical
29
Severe
101
High
158
Moderate
89
Low
17

Of the 394 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

301–394 of 394

  • SevereFDA (Drugs)·D-1267-2014·2014-05-07

    B. Braun Recalls Cefepime Injection Due to Visible Particulate Matter

    B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose injection units because visible particulate matter was found in reserve samples.

    Product
    CEFEPIME HYDROCHLORIDE AND DEXTROSE — CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2014·2014-05-07

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve samples.

    Product
    0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1271-2014·2014-05-07

    B. Braun Recalls FreAmine HBC Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 6.9% FreAmine HBC (Amino Acid Injection) units due to visible particulate matter found in reserve samples.

    Product
    6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1908-2014·2014-05-07

    Pastene Italian Bucatini Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Bucatini because the semolina pasta fails to declare the wheat allergen.

    Product
    Pastene ITALIAN BUCATINI,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7095 UPC: 066086070955
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1910-2014·2014-05-07

    Pastene ITAL Long Fusilli Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of ITAL Long Fusilli pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITAL LONG FUSILLI ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7098 UPC: 066086070986
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2014·2014-05-07

    Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues

    Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.

    Product
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-1895-2014·2014-05-07

    Pastene Italian Spaghetti Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Spaghetti #15 because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN SPAGHETTI #15, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7075 UPC: 066086070757
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2014·2014-05-07

    Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies

    Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.

    Product
    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1903-2014·2014-05-07

    Pastene Italian Stelline Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of Italian Stelline pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN STELLINE #59 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7086 UPC: 066086070863
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1898-2014·2014-05-07

    Pastene Italian Fusilli Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Fusilli #28 because the semolina pasta fails to declare the allergen wheat.

    Product
    Pastene ITALIAN FUSILLI #28, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7081 UPC: 066086070818
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1890-2014·2014-05-07

    Pastene Gemelli Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Gemelli pasta because the packaging fails to declare the wheat allergen.

    Product
    Pastene GEMELLI 104, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7063 UPC: 066086070634
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2014·2014-05-07

    GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values

    GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.

    Product
    GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the revi
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1904-2014·2014-05-07

    Pastene Italian Trivella Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Trivella #69 pasta because the packaging fails to declare wheat, a major allergen.

    Product
    Pastene ITALIAN TRIVELLA #69 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7087 UPC: 066086070870
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1886-2014·2014-05-07

    Losurdo Grated Pecorino Romano Recalled for Listeria Contamination

    Losurdo Foods is recalling one lot of Grated Pecorino Romano cheese due to Listeria monocytogenes contamination.

    Product
    Losurdo IMPORTED GRATED PECORINO ROMANO, NET WT. 80 OZ. (5 LB.) 2.27 Kg, UPC 0 75009 00232 4. Product packaged within black plastic bag, with 5 bags per carton (20 LB) total per carton. Distributor LOSURDO FOODS, INC. 20 Owens Roads Hackensack, NJ 07601.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1533-2014·2014-05-07

    GE Healthcare Recalls MRI Scanners Due to Cradle Release Malfunction

    GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.

    Product
    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnosti
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1909-2014·2014-05-07

    Pastene Italian Orecchiette Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of Italian Orecchiette pasta because the product fails to declare the wheat allergen.

    Product
    Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7097 UPC: 066086070979
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1902-2014·2014-05-07

    Pastene Italian Ditali Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 6,000 cases of Pastene Italian Ditali #45 pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN DITALI #45 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7085 UPC: 066086070856
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1905-2014·2014-05-07

    Pastene Semolina Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene ITAL NIDI #81 pasta because the product fails to declare the wheat allergen.

    Product
    Pastene ITAL NIDI #81 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7090 UPC: 066086070900
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2014·2014-05-07

    Pastene Italian Linguine Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of Italian Linguine #6 because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN LINGUINE #6, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7077 UPC: 066086070771
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1907-2014·2014-05-07

    Pastene Italian Pappardelle Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Pappardelle because the semolina pasta fails to declare the allergen wheat.

    Product
    Pastene ITALIAN PAPPARDELLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7092 UPC: 066086070924
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1900-2014·2014-05-07

    Pastene Italian Rigatoni Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Rigatoni #31 because the semolina pasta fails to declare the allergen wheat.

    Product
    Pastene ITALIAN RIGATONI #31 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7083 UPC: 066086070832
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1887-2014·2014-05-07

    Schwan's Recalls Cheddar Cheese Puffs Due to Listeria Risk

    Schwan's Global Supply Chain is recalling Holiday Foods Cheddar Cheese Puffs because they contain ingredients potentially contaminated with Listeria monocytogenes.

    Product
    Holiday Foods, Cheddar Cheese Puffs, 4800308, UPC 70220748003081, 100 PCS, Not Fully Cooked - Cook Before Eating, Keep Frozen, For Institutional Use Only, Prepared by Holiday Food Inc, Hollywood, Florida 33020.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1891-2014·2014-05-07

    Pastene REGINE 10 Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene REGINE 10 pasta because the product fails to declare the allergen wheat.

    Product
    Pastene REGINE 10, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7064 UPC: 066086070641
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1911-2014·2014-05-07

    Pastene Tricolor Farfalle Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of Tricolor Farfalle pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITAL TRICOLOR FARFALLE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7088 UPC: 066086070887
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1912-2014·2014-05-07

    Pastene Semolina Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene ITAL SPIRAL TRI COLOR pasta because it fails to declare the allergen wheat.

    Product
    Pastene ITAL SPIRAL TRI COLOR,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7093 UPC: 066086070931
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2014·2014-05-07

    Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel

    Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.

    Product
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1901-2014·2014-05-07

    Pastene Italian Shells Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Shells #25 because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7084 UPC: 066086070849
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1889-2014·2014-05-07

    Pastene Mafaldine Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Mafaldine pasta because the product fails to declare the allergen wheat.

    Product
    Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7062 UPC: 066086070627
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2014·2014-05-07

    Acumed Recalls Tension Band Pins Due to Steel Specification Defect

    Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.

    Product
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V237000·2014-05-07

    Ford Recalls 2013-2014 Escape and C-MAX for Air Bag Software Error

    Ford is recalling 2013-2014 Escape and C-MAX vehicles because a software error may delay side-curtain air bag deployment, increasing injury risk in rollovers.

    Product
    FORD — FORD ESCAPE, C-MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1892-2014·2014-05-07

    Pastene Farfalline Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 16 oz bags of Farfalline pasta because the product fails to declare the allergen wheat.

    Product
    Pastene FARFALLINE 78, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7067 UPC: 066086070672
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1899-2014·2014-05-07

    Pastene Italian Capellini Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Capellini #17 because the semolina pasta fails to declare the wheat allergen.

    Product
    Pastene ITALIAN CAPELLINI #17, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7082 UPC: 066086070825
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2014·2014-05-07

    Philips ADAC Nuclear Gamma Cameras Recalled for Potential Patient Contact

    Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.

    Product
    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for in
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1521-2014·2014-05-07

    Fisher Scientific Recalls Sterile Swabs Due to Organism Contamination

    Fisher Scientific is recalling Fisherbrand Sterile Swabs after a customer reported the presence of an organism in a lot of wood applicator swabs.

    Product
    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1906-2014·2014-05-07

    Pastene Italian Farfalle Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Farfalle pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITALIAN FARFALLE #66 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7091 UPC: 066086070917
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1893-2014·2014-05-07

    Pastene Tagliatelle Verdi Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling 6,000 cases of Pastene ITAL Tagliatelle Verdi #80 because the semolina pasta fails to declare the allergen wheat.

    Product
    Pastene ITAL TAGLIATELLE VERDI #80, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7070 UPC: 066086070702
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1897-2014·2014-05-07

    Pastene Italian Ziti Rigati Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene Italian Ziti Rigati #20 because the semolina pasta fails to declare the allergen wheat.

    Product
    Pastene ITALIAN ZITI RIGATI #20, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7079 UPC:066086070795
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1894-2014·2014-05-07

    Pastene Semolina Pasta Recalled for Undeclared Wheat Allergen

    The Pastene Companies Ltd. is recalling Pastene ITAL CAPELLI D'ANGELO #83 semolina pasta because the product fails to declare the allergen wheat.

    Product
    Pastene ITAL CAPELLI D'ANGELO #83, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7074 UPC: 066086070740
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2014·2014-05-07

    Teleflex Recalls Dekna-lok Sutures for Failing Resorption Strength Requirements

    Teleflex Medical is recalling 7,380 units of Dekna-lok sutures because they did not meet minimum resorption strength requirements. The affected products were distributed in the US, Ireland, and Singapore.

    Product
    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1291-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device

    AbbVie is recalling 2,915 Lupron Depot kits because the syringe needle protection device may be defective. The recall covers nationwide distribution and Puerto Rico.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1913-2014·2014-05-07

    Fish Oil Softgels Recalled Due to Mixed Conjugated Linoleic Acid Capsules

    Nutri-Force Nutrition is recalling Fish Oil Softgel Capsules because Conjugated Linoleic Acid capsules were found mixed in the bottles.

    Product
    Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: "Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***".
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1531-2014·2014-05-07

    Siemens IMMULITE Androstenedione Assay Recalled for Over-Recovery

    Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.

    Product
    IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2014·2014-05-07

    Siemens Androstenedione Assay Recall Due to Over-Recovery

    Siemens recalls Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL limit.

    Product
    IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Ana
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2014·2014-05-07

    Medtronic Activa Neurostimulators Recalled for Cycling Feature Labeling

    Medtronic is recalling Activa neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1290-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits With Defective Needle Protection

    AbbVie is recalling 1,530 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2014·2014-05-07

    BD Biosciences Recalls Mislabeled Anti EpCAM PE Reagent Lots

    BD Biosciences is recalling two lots of Anti EpCAM PE reagent because the vials contain CD9 PE antibody instead of the labeled EpCAM antibody.

    Product
    Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1283-2014·2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Caraco Pharmaceutical Laboratories is recalling 160,105 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1287-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection

    AbbVie is recalling 7,362 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2014·2014-05-07

    Teva Recalls Fluoxetine Capsules Due to Chemical Contamination and Odor

    Teva Pharmaceuticals is recalling Fluoxetine Capsules due to a customer complaint trend regarding capsule odor, indicating chemical contamination.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2014·2014-05-07

    Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

    Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

    Product
    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1257-2014·2014-05-07

    John W Hollis Inc Recalls Phosphatidylcholine Injection Due to Labeling Error

    John W Hollis Inc is recalling 7 vials of Phosphatidylcholine Solution for Injection because the expiration date on the label is earlier than the date listed on the vial.

    Product
    Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1262-2014·2014-05-07

    Piramal Recalls Sevoflurane Inhalation Anesthetic Due to pH Failure

    Piramal Critical Care is recalling 12,600 bottles of Sevoflurane inhalation anesthetic because the product was too acidic, failing pH specifications.

    Product
    SEVOFLURANE — SEVOFLURANE (SEVOFLURANE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1517-2014·2014-05-07

    Siemens IMMULITE Total IgE Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.

    Product
    IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1530-2014·2014-05-07

    Alfa Wassermann ACE AST Reagent Recalled for Low Absorbance Readings

    Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.

    Product
    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2014·2014-05-07

    Alfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings

    Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.

    Product
    Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2014·2014-05-07

    Medtronic Neurostimulators Recalled for Cycling Feature Labeling Concerns

    Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.

    Product
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), It
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1518-2014·2014-05-07

    Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.

    Product
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1527-2014·2014-05-07

    Laurimed Recalls PolypVac Microdebriders Due to Premature Mechanism Shutdown

    Laurimed LLC is recalling 58 PolypVac 3.5mm Microdebriders because the reciprocation mechanism may turn off prematurely due to a component failure in the handle.

    Product
    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1526-2014·2014-05-07

    Medtronic External Neurostimulators Recalled for Cycling Feature Labeling Issue

    Medtronic is recalling external neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1914-2014·2014-05-07

    Rising Moon Organics Pesto Ravioli Recalled for Missing Pine Nut Allergen Labeling

    Carmel Food Group is recalling Rising Moon Organics Basil, Asiago & Pine Nut Pesto Ravioli because the packaging incorrectly omits pine nuts from the allergen statement.

    Product
    RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1298-2014·2014-05-07

    P&L Developments Recalls Children's Cold and Cough Liquid for Precipitate

    P&L Developments is recalling 1,363,338 bottles of Children's Triacting Night Time Cold & Cough with PE because small amounts of diphenhydramine and mannitol precipitated out of solution.

    Product
    Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) F
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1297-2014·2014-05-07

    Caraco Recalls Children's Cetirizine Tablets Due to Impurity Failures

    Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Specialty Diluent Due to Inaccurate CRP Results

    Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.

    Product
    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1514-2014·2014-05-07

    Elekta Recalls HexaPOD evo RT Couchtop Units Due to Loose Screw Risk

    Elekta is recalling 266 HexaPOD evo RT Couchtop units because screws may become loose if not properly tightened with a torque wrench.

    Product
    HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1522-2014·2014-05-07

    Integra CUSA Excel Disposable Wrench Recalled for Incorrect Assembly

    Integra LifeSciences is recalling CUSA Excel Disposable Wrenches because some units were incorrectly assembled with the wrong hex wrench insert.

    Product
    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the steril
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1520-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Diluent Packs Due to Inaccurate Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1284-2014·2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failure

    Caraco Pharmaceutical Laboratories is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah Mc
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1282-2014·2014-05-07

    Baxter Recalls 0.9% Sodium Chloride Irrigation Due to Nylon Fibers

    Baxter Healthcare Corp. is recalling 211,752 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL, due to the presence of nylon fibers.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1534-2014·2014-05-07

    Teleflex Recalls CAPIO Absorbable Surgical Sutures for Strength Defects

    Teleflex Medical is recalling CAPIO absorbable surgical sutures because they did not meet minimum resorption strength requirements. The recall affects 7,380 units distributed in the US, Ireland, and Singapore.

    Product
    CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1259-2014·2014-05-07

    John W Hollis Recalls Polidocanol 1% Solution Due to Incorrect Expiration Date

    John W Hollis Inc is recalling 2 vials of Polidocanol 1% Solution because the expiration date on the vial is earlier than the date listed on the label.

    Product
    Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-1296-2014·2014-05-07

    Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities

    Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.

    Product
    Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1258-2014·2014-05-07

    John W Hollis Recalls Papaverine, Phentolamine, and Atropine Solution Vials

    John W Hollis Inc is recalling specific vials of Papaverine, Phentolamine, and Atropine solution due to an incorrect expiration date on the label.

    Product
    Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-1286-2014·2014-05-07

    Aaron Industries Recalls Tussin DM Cough Syrup Due to Precipitate

    Aaron Industries is recalling 108,792 bottles of Tussin DM cough syrup because a white substance, identified as the active ingredient Guaifenesin, was observed in some bottles.

    Product
    Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, La
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1299-2014·2014-05-07

    Apotex Recalls Risperidone Oral Solution Due to Impurity Specification Failure

    Apotex Inc. is recalling Risperidone Oral Solution because it failed impurity specifications at the 18-month stability time point.

    Product
    Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1285-2014·2014-05-07

    Glytone Acne Facial Cleanser Recalled for Viscosity Specification Failure

    Genesis Pharmaceuticals is recalling 461 bottles of Glytone Acne Treatment Facial Cleanser due to out-of-specification viscosity results.

    Product
    Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·14168·2014-05-05

    Cannondale Recalls 2014 Tandem Bicycles Due to Fork Breakage Risk

    Cycling Sports Group is recalling about 80 2014 Cannondale tandem bicycles because the fork can break, causing riders to lose control and potentially be injured.

    Product
    2014 Cannondale Tandem Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·027-2014·2014-05-03

    Schnucks Kitchen Recalls Curry Chicken Salad for Possible Listeria Contamination

    Schnucks Kitchen is recalling approximately 130 pounds of Curry White Meat Chicken Salad due to possible Listeria monocytogenes contamination. The product was sold in five states.

    Product
    Missouri Firm Recalls Curry Chicken Salad for Possible Listeria Contamination
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·14V229000·2014-05-02

    Nissan Recalls 2014 Pathfinder, Rogue, and Infiniti QX60 for Loose Lug Nuts

    Nissan is recalling 2014 Pathfinder, Rogue, and Infiniti QX60 vehicles because a right-side lug nut may not be properly tightened, posing a wheel separation risk.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, QX60, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V231000·2014-05-02

    Federal Coach Recalls 2010 Spirit and Premier Buses for Fire Risk

    Federal Coach is recalling 2010 Spirit and Premier buses because voltage spikes may damage door actuator circuit boards, increasing the risk of fire.

    Product
    FEDERAL COACH — FEDERAL COACH SPIRIT, PREMIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V256000·2014-05-02

    Trans Tech Recalls 2013 School Buses with Wheelchair Lift Fire Risk

    Trans Tech Bus is recalling 2013 SC139DSFP500 school buses equipped with specific Ricon wheelchair lifts. An armored cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    TRANS TECH — TRANS TECH SC139DSFP500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V230000·2014-05-02

    Ferrara Intruder Ember Cab and Chassis Seat Belt Recall

    HME, Inc. is recalling one 2013 Ferrara Intruder Ember emergency vehicle because the seat belt latch plate can become partially engaged, making it difficult to unlatch.

    Product
    FERRARA — FERRARA INTRUDER EMBER CAB/CHASSI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V228000·2014-05-01

    Coach and Equipment Recalls 2013 Metro Lite and Phoenix Buses

    Coach and Equipment is recalling 2013 Metro Lite and Phoenix buses because a wheelchair lift cable may cause a short circuit and fire.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT METRO LITE, PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V227000·2014-05-01

    Polaris Recalls Victory Motorcycles Due to Engine Seizure Risk

    Polaris is recalling specific 2014-2015 Victory motorcycles because an engine defect may cause the engine to seize, increasing the risk of a crash.

    Product
    VICTORY — VICTORY GUNNER, VISION, VEGAS EIGHT BALL, BOARDWALK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14732·2014-05-01

    J. Crew Recalls Baby Coveralls Due to Choking Hazard

    J. Crew is recalling approximately 8,700 baby coveralls because snaps can detach, posing a choking hazard to young children.

    Product
    Baby Coveralls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14733·2014-05-01

    Altria Recalls 3-in-1 Flashlight Due to Burn and Injury Hazards

    Altria Group Distribution Company is recalling 365,000 Marlboro promotional flashlights because matches can ignite inside the device, posing burn and injury risks.

    Product
    3-in-1 flashlight, compass and match holder
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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