The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
305
High
392
Moderate
171
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 29% are Severe.

401–500 of 1035

  • SevereFDA (Food)·F-0067-2017·2016-10-19

    Publix Cherry Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Cherry Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Cherry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2017·2016-10-19

    HeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector

    HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.

    Product
    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart…
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Drugs)·D-0057-2017·2016-10-19

    Pharmedium Recalls Ketamine HCl Injection Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 54 syringes of ketamine HCl injection because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0067-2017·2016-10-19

    Brathwaites Oliver Medical Recalls Introes Pocket Bougie Endotracheal Tube Introducers

    Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.

    Product
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-0014-2017·2016-10-19

    FDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about sterility.

    Product
    Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate 2 mg/mL due to stability data that does not support the expiry date, posing a risk of potential loss of potency.

    Product
    morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0079-2017·2016-10-19

    R.W. Garcia Sweet Potato Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling sweet potato crackers due to the detection of metal fragments in the raw material.

    Product
    RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Black & White sesame Seeds), Gluten Free, Net Wt., 180g and 850g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0068-2017·2016-10-19

    Publix Guava Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Guava Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Guava Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0064-2017·2016-10-19

    Gold Standard Baking Recalls Strawberry Cheese Danish Due to Metal Shavings

    Gold Standard Baking is recalling The Bakery Strawberry Cheese Danish because of the presence of small metal shavings. The product was distributed nationwide by Walmart.

    Product
    The Bakery Strawberry Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742100401
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0052-2017·2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2017·2016-10-19

    Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.

    Product
    Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0077-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0087-2017·2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0009-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Gourmet Blueberry Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0013-2017·2016-10-19

    Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.

    Product
    Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0040-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns

    Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2017·2016-10-19

    Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0090-2017·2016-10-19

    Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0024-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0070-2017·2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0036-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2017·2016-10-19

    Pharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 12,173 syringes of ketamine HCl Injection because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0100-2017·2016-10-19

    Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

    Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications.

    Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2017·2016-10-19

    Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.

    Product
    Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V758000·2016-10-19

    Mercedes-Benz Recalls 2017 E300 Sedans for Fuel Pump Wiring Defect

    Mercedes-Benz is recalling 2017 E300 Sedans because the rear seat frame may damage fuel pump wiring, potentially causing an engine stall and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2017·2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0073-2017·2016-10-19

    Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,700 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 545 syringes of morphine sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0093-2017·2016-10-19

    Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide

    Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.

    Product
    fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0015-2017·2016-10-19

    Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about sterility.

    Product
    Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 592 syringes of morphine sulfate because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0069-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 3,159 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a risk of reduced potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,522 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0012-2017·2016-10-19

    Leiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Cefuroxime Sodium Injection because products were made with recalled filters, raising sterility concerns.

    Product
    Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0017-2017·2016-10-19

    Leiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns

    Leiter's Compounding is recalling placebo ophthalmic suspensions because they were produced using recalled filters, raising concerns about sterility.

    Product
    Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2017·2016-10-19

    Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2017·2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 380 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0035-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Double Dutch Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0080-2017·2016-10-19

    Contour Zero-Gravity Radiation Protection System Recalled for Cable Failure Risk

    Contour Fabricators is recalling 447 Zero-Gravity radiation protection systems because excessive cable rotation may cause the shield to fall, posing an injury risk.

    Product
    Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0073-2017·2016-10-19

    R.W. Garcia Recalls 365 Lightly Salted Tortilla Chips for Metal Fragments

    R.W. Garcia Co., Inc. is recalling 365 Lightly Salted Tortilla Chips, Multigrain, because metal fragments were detected in the raw material.

    Product
    365, Lightly Salted Tortilla Chips, Multigrain, Net Wt. 16oz. (1 lb.) 454g, Distributed by Whole Foods Market, Austin, TX 78703.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0015-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential metal fragments in the sugar topping.

    Product
    Gourmet Lemon Poppy Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0054-2017·2016-10-19

    Publix Almond Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Almond Strip Danish due to the presence of small metal shavings.

    Product
    Publix Almond Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0023-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and breads, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Tripple Berry Loaf Bread (1 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0021-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Monster Size Pina Colada Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0072-2017·2016-10-19

    Harris Teeter Multigrain Tortilla Chips Recalled for Metal Fragments

    R.W. Garcia Co. is recalling Harris Teeter Multigrain Tortilla Chips because metal fragments were detected in the raw material.

    Product
    Harris Teeter, Multigrain, Tortilla Chips, Net Wt. 12 oz. (340g), Produced by Harris Teeter, Mathews, NC 28105.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0071-2017·2016-10-19

    GE OEC Brivo Mobile C-Arm X-Ray Recall for Uncontrolled Motion

    GE Healthcare is recalling 148 OEC Brivo mobile C-arm X-ray units because a circuit board failure may cause the C-arm to move vertically without command.

    Product
    OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0012-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Butter Rum Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0033-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Sour Creme Cookies with Chocolate Chips (6 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0063-2017·2016-10-19

    Gold Standard Baking Recalls Raspberry Danish Due to Metal Shavings

    Gold Standard Baking is recalling The Bakery Raspberry Danish because of the presence of small metal shavings. The product was distributed nationwide by Walmart.

    Product
    The Bakery Raspberry Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2017·2016-10-19

    Varian Head Frame Posts Recalled Due to Rotation Risk

    Varian Medical Systems is recalling 75 Head Frame Posts because they can rotate easily on the mounting cam. No serious injuries have been reported.

    Product
    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0019-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Gourmet Cranberry Orange Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0078-2017·2016-10-19

    R.W. Garcia Sweet Potato Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling 3 Seed Sweet Potato Crackers because metal fragments were detected in the raw material.

    Product
    RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Sesame & Chia), Gluten Free, Net Wt., 30 oz., Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0017-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery items, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Red Velvet Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0066-2017·2016-10-19

    Gold Standard Baking Recalls Raspberry Crumb Coffee Cake Due to Metal Shavings

    Gold Standard Baking is recalling The Bakery Raspberry Crumb Coffee Cake because it may contain small metal shavings. The product was distributed nationwide by Walmart.

    Product
    The Bakery Raspberry Crumb Coffee Cake| Net Wt 15 OZ (425g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742052953
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2017·2016-10-19

    Fujifilm Synapse PACS Software Recalled for Potential Image Data Errors

    Fujifilm Medical Systems is recalling Synapse PACS software versions 4.0 through 4.3 because patient image data may be incorrect.

    Product
    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0050-2017·2016-10-19

    Kellogg's Eggo Nutri-Grain Whole Wheat Waffles Recalled for Listeria Risk

    Kellogg's is recalling Eggo Nutri-Grain Whole Wheat Waffles due to potential Listeria monocytogenes contamination. Consumers should check their pantries for affected cartons.

    Product
    Kelloggs ¿ Eggo ¿ Nutri-Grain¿ Whole Wheat Waffles 12.3 oz (10 ct) retail carton 8, 12.3 oz retail cartons per case
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-0058-2017·2016-10-19

    Gold Standard Baking Recalls Strawberry Cheese Danish Due to Metal Shavings

    Gold Standard Baking is recalling Strawberry Cheese Decadent Danish products due to the presence of small metal shavings.

    Product
    Strawberry Cheese Decadent Danish | NET WT 14 OZ (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050064
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0036-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Raisin Bran Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0076-2017·2016-10-19

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

    Product
    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0037-2017·2016-10-19

    Weis Markets Recalls Pistachio Muffins Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including pistachio muffins, due to potential metal fragments in the sugar topping.

    Product
    Gourmet Pistachio Flavored Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0086-2017·2016-10-19

    Pure Ghee Recalls Vrindavan Cow Ghee Due to Undeclared Milk Allergen

    Pure Ghee, Inc. is voluntarily recalling Vrindavan Cow Ghee because it contains an undeclared milk allergen. The product was distributed in New Jersey and New York.

    Product
    "VRINDAVAN" COW GHEE, Ingredients: 100% clarified butter
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0027-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins, cookies, and bread, due to potential metal fragments in the sugar topping.

    Product
    Peach Melba Loaf Bread (1 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0038-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2017·2016-10-19

    Siemens Symbia T Series SPECT + CT Recall for Bearing Failure Risk

    Siemens Medical Solutions is recalling 1,109 Symbia T Series SPECT + CT systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2017·2016-10-19

    Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor

    Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Universal Acetabular Cup Positioner/Impactor because the thread length may protrude past the dome of the acetabular trial or implant.

    Product
    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0053-2017·2016-10-19

    Publix Raspberry Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Raspberry Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Raspberry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0031-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Old Fashioned Shortcake (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0061-2017·2016-10-19

    Siemens Symbia S Camera Systems Recalled for Bearing Failure Risk

    Siemens Medical Solutions is recalling Symbia S camera systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0014-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Banana Nut Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0076-2017·2016-10-19

    R.W. Garcia Kale Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling 49 cases of 3 Seed Kale Crackers due to the detection of metal fragments in raw material.

    Product
    RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0069-2017·2016-10-19

    Cardinal Health Recalls V. Mueller Spinal Distraction Screws Due to Corrosion

    Cardinal Health 200, LLC is recalling V. Mueller Neuro/Spine Shadow-Line Spinal Distraction Screws because corrosion was demonstrated on the screw surface.

    Product
    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0085-2017·2016-10-19

    Trader Joe's Hummus Dip Recalled for Potential Sesame Allergen

    Tribe Mediterranean Foods is recalling Trader Joe's Freshly Made Original Hummus Dip (Tahini Free) because it may contain sesame, a major food allergen.

    Product
    Trader Joes Freshly Made Original Hummus Dip (Tahini Free), packaged in 16 oz. clear plastic cups SKU: 00299091
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0022-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Gourmet Chocolate Chip Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0077-2017·2016-10-19

    R.W. Garcia Kale Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling Kale Crackers because metal fragments were detected in the raw material. Consumers should stop eating the product.

    Product
    RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0070-2017·2016-10-19

    Medtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors

    Medtronic is recalling 14 O-arm O2 Surgical Imaging Systems because spatial calibration may be erroneous in navigated images, potentially affecting surgical accuracy.

    Product
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0043-2017·2016-10-19

    Doctor Kracker Pumpkin Seed Cheddar Crispbreads Recalled for Undeclared Milk

    Kracker Enterprises is recalling Doctor Kracker Pumpkin Seed Cheddar Crispbreads because the ingredient statement does not list milk, despite the product name containing Cheddar.

    Product
    Doctor Kracker Pumpkin Seed Cheddar Crispbreads Net Wt. 7 oz. (200g) in cardboard container.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0056-2017·2016-10-19

    Gold Standard Baking Recalls Cheese Decadent Danish Due to Metal Shavings

    Gold Standard Baking is recalling Cheese Decadent Danish products because they may contain small metal shavings.

    Product
    Cheese Decadent Danish | NET WT 14 OZ (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050019
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2017·2016-10-19

    ConMed Recalls HeatWave Electrodes Due to Insulation Damage Risk

    ConMed is recalling specific HeatWave Electrodes because damaged shaft insulation could increase the risk of patient burns during arthroscopic procedures.

    Product
    CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0061-2017·2016-10-19

    Archer Farms Strawberry Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Archer Farms Strawberry Danish due to the presence of small metal shavings.

    Product
    Archer Farms Strawberry Danish | NET WT 14 OZ (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0052-2017·2016-10-19

    Publix Apple Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Apple Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Apple Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0057-2017·2016-10-19

    Gold Standard Baking Recalls Cherry Decadent Danish Due to Metal Shavings

    Gold Standard Baking is recalling Cherry Decadent Danish products due to the presence of small metal shavings. The recall covers 461 cases distributed nationwide.

    Product
    Cherry Decadent Danish | NET WT 14 OZ (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050033
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2017·2016-10-19

    Natus Medical Recalls Medix NatalCare LX Incubators Due to Wheel Defect

    Natus Medical is recalling 104 Medix NatalCare LX Intensive Care Incubators because a defective base weld may cause wheels to bend out of alignment.

    Product
    The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-0070-2017·2016-10-19

    Trader Joe's Veggie Flaxseed Tortilla Chips Recalled for Metal Fragments

    R.W. Garcia Co. is recalling Trader Joe's Veggie Flaxseed Tortilla Chips due to the detection of foreign metal fragments in the raw material.

    Product
    Trader Joes, Veggie Flaxseed Tortilla Chips, Net Wt. 12oz. (340g), Distributed and Sold by Trader Joes, Monrovia, CA 91014.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0062-2017·2016-10-19

    Gold Standard Baking Recalls Cheese Danish for Metal Shavings

    Gold Standard Baking is recalling The Bakery Cheese Danish sold at Walmart due to the presence of small metal shavings.

    Product
    The Bakery Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2017·2016-10-19

    TheraSphere Y-90 Microspheres Recalled for Incorrect Radioactivity Labeling

    Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere Y-90 Glass Microspheres shipped to Hong Kong because the labeled radioactivity was incorrect.

    Product
    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0018-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gingerbread Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states

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