The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
242
High
453
Moderate
173
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 23% 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 (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-0096-2017·2016-10-19

    Hospira Recalls Marcaine Injection Due to Sterility and Potency Issues

    Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (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-0016-2017·2016-10-19

    Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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, C
    Category
    Drug
    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-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
  • 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-0034-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
    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
  • 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-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-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-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-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-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-0049-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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-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-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-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-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-0011-2017·2016-10-19

    Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Brilliant Blue G 0.025% 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 70360-008-35
    Category
    Drug
    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 failu
    Category
    Medical Device
    Distribution
    26 states
  • 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-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 (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-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-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 (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-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-0055-2017·2016-10-19

    Publix Maple Walnut Strip Danish Recalled for Metal Shavings

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

    Product
    Publix Maple Walnut Strip Danish | Count, 1 | NET WT 14.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0011-2017·2016-10-19

    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 Cherry Almond Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • 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 (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
  • HighNHTSA·16V756000·2016-10-19

    Newmar Recalls 2017 King Aire Motorhomes Due to Radar Mounting Defect

    Newmar is recalling 2017 King Aire motorhomes because the collision mitigation radar may be mounted upside down, potentially decreasing performance and increasing crash risk.

    Product
    NEWMAR — NEWMAR KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-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 (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-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-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-0016-2017·2016-10-19

    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 Cinnamon Chip Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0074-2017·2016-10-19

    R.W. Garcia Recalls 365 White Corn Tortilla Chips for Metal Fragments

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

    Product
    365, White Corn, Tortilla Chips, Lightly Salted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.
    Category
    Food
    Distribution
    0 states
  • 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 compon
    Category
    Medical Device
    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-0038-2017·2016-10-19

    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 Apple Spice Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • 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-0049-2017·2016-10-19

    Nature's Power Solutions Acidophilus Blend Recalled for Undeclared Milk

    Complete Packaging & Manufacturing is recalling Nature's Power Solutions Acidophilus Blend dietary supplements because they contain undeclared milk, a major food allergen.

    Product
    Dietary Supplement Acidophilus Blend, 90 capsules, Product No. E-420, packaged in 225cc HDPE white bottle, room temp, sold individually
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2017·2016-10-19

    Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues

    Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0080-2017·2016-10-19

    Taylor Farms Cranberry Walnut Salad Recalled for Incorrect Allergen Labeling

    Taylor Farms is recalling Cranberry Walnut Salad kits because some packages have incorrect labels that fail to declare walnuts or wheat.

    Product
    Taylor Farms Cranberry Walnut Salad; Salad kit for one: Baby Lettuce Blend, Feta Cheese, Flat Bread Chips, Dried cranberries and Walnuts and Raspberry Vinaigrette dressing. Distributed by: Taylor Farms Inc., Salinas, CA.
    Category
    Food
    Distribution
    6 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-0028-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

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

    Product
    Blueberry Lemon Loaf Bread (1 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0007-2017·2016-10-19

    Cabela's Maple Nut Candies Recalled for Undeclared Peanut Allergen

    Rucker's Wholesale & Service Co. is recalling Cabela's Maple Nut candies because the label fails to list peanuts, a major allergen.

    Product
    Cabela's classic candies Maple nut packaged in 2.7 oz. clear plast ice bag with brown label attached with brown lettering.
    Category
    Food
    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 (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 (Food)·F-0065-2017·2016-10-19

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

    Gold Standard Baking is recalling The Bakery Apple Crumb Coffee Cake because it may contain small metal shavings.

    Product
    The Bakery Apple 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-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
  • 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 (Food)·F-0071-2017·2016-10-19

    R.W. Garcia Recalls Central Market Tortilla Chips Due to Metal Fragments

    R.W. Garcia Co., Inc. is recalling Central Market Tortilla Chips, Veggie & Seed Blend, because metal fragments were detected in the raw material.

    Product
    Central Market, Tortilla Chips, Veggie & Seed Blend, Net Wt.; 12oz (340g), Distributed by H.E.B Central Markets, Austin, TX 78735.
    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-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 (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-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 provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-0010-2017·2016-10-19

    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 Corn Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • 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, C
    Category
    Food
    Distribution
    0 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-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 (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-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-0020-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

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

    Product
    Gourmet Pumpkin Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • 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 (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 to
    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-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 (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 (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-0075-2017·2016-10-19

    365 White Corn Tortilla Chips Recalled for Metal Fragments

    R.W. Garcia Co. is recalling 365 White Corn Tortilla Chips due to metal fragments detected in raw material.

    Product
    365, White Corn, Tortilla Chips, Unsalted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.
    Category
    Food
    Distribution
    0 states
  • 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 (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 2000/I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0059-2017·2016-10-19

    Kroger Raspberry Danish Strips Recalled for Metal Shavings

    Gold Standard Baking is recalling Kroger Raspberry Danish Strips due to the presence of small metal shavings.

    Product
    Kroger Raspberry Danish Strip, Naturally and Artificially Flavored | NET WT 14 OZ (396g) | Distributed by The Kroger Co., Cincinnati, Ohio 45202 | UPC: 011110836489
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0060-2017·2016-10-19

    Archer Farms Cheese Danish Recalled for Metal Shavings

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

    Product
    Archer Farms Cheese Danish | NET WT 14 OZ (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094
    Category
    Food
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.