The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
116
High
418
Moderate
173
Low
34

Of the 802 recalls this month scored against our rubric, 8% are Critical, 14% are Severe.

1–100 of 802

  • CriticalFDA (Food)·F-0478-2017·2016-11-30

    Yoma Myanmar Tea Salad Snack Recalled for Undeclared Peanuts

    Yoma Myanmar is recalling Tea Salad Snack products because they contain undeclared peanuts. Consumers with peanut allergies should not eat the product.

    Product
    Yoma Myanmar Tea Salad Snack - Regular, 7 oz cello bag. Product of Myanmar
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0502-2017·2016-11-30

    Publix Chocolate Cookie Dough Ice Cream Recalled for Listeria Risk

    Publix Super Markets is recalling 1/2 gallon cartons of Premium Chocolate Cookie Dough Ice Cream due to possible Listeria monocytogenes contamination.

    Product
    Publix Premium Chocolate Cookie Dough Ice Cream, 1/2 gallon carton.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0481-2017·2016-11-30

    Café Valley Recalls Banana Nut Mini Muffins for Undeclared Walnuts

    Café Valley Inc. is voluntarily recalling 1,170 cases of Banana Nut mini muffins mislabeled as Lemon Poppy Seed because they may contain undeclared walnuts.

    Product
    12ct Banana Nut mini muffins labeled as 12ct Lemon poppy seed mini muffins; Date code 160803 ink jet printed on top near the label.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0477-2017·2016-11-30

    Yoma Myanmar Tea Salad Snack Recalled for Undeclared Peanuts

    Yoma Myanmar is recalling its Tea Salad Snack - Spicy because it contains undeclared peanuts. Consumers should stop eating the product.

    Product
    Yoma Myanmar Tea Salad Snack - Spicy, 7 oz cello bag. Product of Myanmar
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0501-2017·2016-11-30

    Stewart's Sportade Fruit Punch Recalled for Undeclared Milk Allergen

    Stewart's Shops Corp is recalling 1,622 bottles of Sportade Fruit Punch Isotonic Beverage due to potential undeclared milk content.

    Product
    Stewart's SPORTADE FRUIT PUNCH Isotonic Beverage 20 Fl Oz (591 mL), UPC 0 82086 31006 8. The product is packaged in a plastic bottle, and has a black label with a red plastic cap.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0479-2017·2016-11-30

    Blue Bunny Ice Cream Recalled for Listeria Contamination Risk

    Wells Enterprises is recalling specific lots of Blue Bunny Hoppin' Holidoodle ice cream due to potential Listeria monocytogenes contamination.

    Product
    Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude).
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0153-2017·2016-11-30

    Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips

    Hospira is recalling specific lots of Fentanyl Citrate Injection ampules because broken tips may compromise sterility.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0653-2017·2016-11-30

    AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk

    AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.

    Product
    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when con
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-0527-2017·2016-11-30

    Free2b Sun Cups Chocolate Recalled for Potential Milk Contamination

    Seth Ellis Chocolatier is recalling Free2b Sun Cups Chocolate due to potential contamination with milk ingredients. The recall covers 189 master cases distributed nationwide.

    Product
    Free2b Sun Cups Chocolate. Made With SunButter Sunflower Spread. Packaged in 2 Cups. Net weight 1.5 oz (45g) and 1 Cup. Net weight 0.75 oz (21g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2017·2016-11-30

    VistaPharm Recalls Lactulose Solution Due to Bacterial Contamination

    VistaPharm is recalling Lactulose Solution, USP, 10 g/15 mL, because bulk solution tested positive for Burkholderia cepacia bacteria.

    Product
    Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0523-2017·2016-11-30

    CSM Bakery Products Recalls White Cake Mix for Undeclared Peanut

    CSM Bakery Products is recalling Brill White Crm Cake Mix because it contains undeclared peanut protein. The product was distributed across 19 states and two territories.

    Product
    Brill White Crm Cake Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0376-2017·2016-11-30

    Philips CT Scanner Recall Due to Potential Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0517-2017·2016-11-30

    CSM Bakery Products Recalls Donut Base for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling BM Westco 1440 Yst Rds Donut Base due to undeclared peanut protein. The product was distributed across 19 states and two territories.

    Product
    BM Westco 1440 Yst Rds Donut Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0633-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.

    Product
    Waste Management Kit. Catalog Number K10-04381AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2017·2016-11-30

    Philips CT Scanner Recall Due to Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2017·2016-11-30

    DiaSorin Recalls LIAISON Estradiol II Gen Assay Due to Cross-Reactivity

    DiaSorin is recalling the LIAISON Estradiol II Gen assay because it may produce inaccurate results for patients treated with fulvestrant.

    Product
    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laborat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0506-2017·2016-11-30

    CSM Bakery Products Recalls Donut Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling BM Westco Sup-R-Roll Donut Mix because it contains undeclared peanut protein. The product was distributed in multiple US states and territories.

    Product
    BM Westco Sup-R-Roll Donut Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0655-2017·2016-11-30

    Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach

    Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.

    Product
    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0512-2017·2016-11-30

    CSM Bakery Recalls 7-Eleven Sugar Cookie Base for Undeclared Peanut

    CSM Bakery Products NA is recalling 7-Eleven Sugar Cookie Base, 50#, because it contains undeclared peanut protein. The product was distributed across 19 states and two territories.

    Product
    7-Eleven Sugar Cookie Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0520-2017·2016-11-30

    CSM Bakery Cream Cake Mix Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling 38260 Cream Cake Mix because it contains undeclared peanut protein. The product was distributed in 19 states and two territories.

    Product
    38260 Cream Cake Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0514-2017·2016-11-30

    CSM Bakery Recalls 7-Eleven Spice Cookie Base for Undeclared Peanut

    CSM Bakery Products NA is recalling 7-Eleven Spice Cookie Base because it contains undeclared peanut protein. The product was distributed in multiple states and territories.

    Product
    7-Eleven Spice Cookie Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0516-2017·2016-11-30

    CSM Bakery Recalls ZT Banana Bread Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling ZT Banana Bread Mix because it contains undeclared peanut protein. The product was distributed in 19 states, Puerto Rico, and Guam.

    Product
    ZT Banana Bread Mix, 13.5#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0530-2017·2016-11-30

    EN-R-G Foods Recalls Protein Chews Due to Nausea and Vomiting Complaints

    EN-R-G Foods is recalling Cherry Lime, Raspberry, and Juneberry Protein Chews due to consumer complaints of nausea and vomiting after consumption.

    Product
    Protein Chews Raspberry,1.8oz, film package, 12 packets per box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0522-2017·2016-11-30

    CSM Bakery Products Recalls Cinnabon Rolls Due to Undeclared Peanut

    CSM Bakery Products is recalling Cinnabon Cinn Rl BS rolls because they contain undeclared peanut protein. The product was distributed to multiple US states and territories.

    Product
    Cinnabon Cinn Rl BS, 50# International
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·16V863000·2016-11-30

    LGS Recalls 2017 Pace, Cargo Express, and Look Cargo Trailers

    LGS Industries is recalling 2017 Pace, Cargo Express, and Look cargo trailers because a defective weld could cause the ramp door bracket to detach, creating a crushing hazard.

    Product
    PACE — PACE, CARGO EXPRESS, LOOK CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0046-2017·2016-11-30

    Enlightened Peanut Butter Ice Cream Recalled for Undeclared Peanuts

    Cedar Crest Specialties is recalling Enlightened Peanut Butter Chocolate Chip Ice Cream because some pints may contain undeclared peanuts due to packaging errors.

    Product
    Enlightened Peanut Butter Chocolate Chip Ice Cream, one pint
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0623-2017·2016-11-30

    Greatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer

    Greatbatch Medical is recalling Stiffer Coaxial Micro-Introducers because a rotating luer detached from the dilator hub during use.

    Product
    Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. Th
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·16V861000·2016-11-30

    Cummins Recalls 2015-2016 Generator Sets Due to Door Hinge Failure Risk

    Cummins is recalling 164 model year 2015-2016 generator sets because door hinges may fail, causing doors to detach and create road hazards.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2017·2016-11-30

    Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

    Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

    Product
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0524-2017·2016-11-30

    CSM Bakery Recalls Choco Cream Cake Base Due to Undeclared Peanut

    CSM Bakery Products NA is recalling Brill Choco Cream Cake Base because it contains undeclared peanut protein. The product was distributed across 19 states, Puerto Rico, and Guam.

    Product
    Brill Choco Cream Cake Base, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0622-2017·2016-11-30

    Toshiba Aquilion Prime CT System Recalled for Cooling Oil Leak Risk

    Toshiba American Medical Systems is recalling Aquilion Prime CT systems because cooling oil in the x-ray tube heat exchanger may leak during operation.

    Product
    Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0503-2017·2016-11-30

    JML Holdings Recalls Three Way Popcorn Sampler for Undeclared Eggs

    JML Holdings Inc is recalling Three Way Popcorn Sampler products due to undeclared eggs on the label. The products were distributed in Illinois, Michigan, and Ohio.

    Product
    Three Way Popcorn Sampler that contains three types of popcorn (cheese, carmel and buttered popcorn) packed inside one unlabeled clear plastic bag, physically divided by a three-way paperboard divider. The bag is packed inside a metal tin.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0614-2017·2016-11-30

    Merge Healthcare Recalls RadSuite Software Due to Image Display Malfunction

    Merge Healthcare is recalling RadSuite software versions 8.30.7.8 through 8.31 because images may not appear readable, potentially delaying care or causing patient re-exposure to radiation.

    Product
    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0511-2017·2016-11-30

    CSM Bakery Products Recalls Bread Mix for Undeclared Peanut Protein

    CSM Bakery Products NA is recalling BM Westco New Horizon Yrd Mix, 50# due to undeclared peanut protein. The product was distributed across multiple states and territories.

    Product
    BM Westco New Horizon Yrd Mix, 50#
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0650-2017·2016-11-30

    DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

    DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

    Product
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0635-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is recalling 53 Procedure Kits due to a compromised sterile barrier. The kits were distributed nationwide to specific states and Japan.

    Product
    Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2017·2016-11-30

    Bausch + Lomb Recalls PeroxiClear Peroxide Solution for Excess Residuals

    Bausch + Lomb is recalling PeroxiClear Peroxide Solution because the product was found to contain excess residual levels of hydrogen peroxide.

    Product
    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Sol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0528-2017·2016-11-30

    Heartland Entrees Dumplings and Broth Recalled for Undeclared Milk

    St Clair Foods, Inc. is recalling Heartland Entrees Dumplings and Broth because the product contains undeclared milk.

    Product
    HEARTLAND ENTREES DUMPLINGS AND BROTH, Product Code 856140, NET WEIGHT: (320 ozs)(9.09 kg)(4-5 Lbs), KEEP FROZEN
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0632-2017·2016-11-30

    Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier

    Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.

    Product
    Manifold Kit. Catalog Number K09-11867AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Oversized Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0626-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic orig
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0644-2017·2016-11-30

    Synthes 2.5 mm Reaming Rods Recalled for Delaminating Peel Pouches

    Synthes (USA) Products LLC is recalling 2,157 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0640-2017·2016-11-30

    Synthes 3.0 mm Guide Rods Recalled for Delaminating Peel Pouches

    Synthes (USA) Products LLC is recalling 319 sterile 3.0 mm Guide Rods because their peel pouches are delaminating.

    Product
    3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0504-2017·2016-11-30

    Westby Coop Creamery Recalls 4% Cottage Cheese for Phosphatase Residue

    Westby Coop Creamery is recalling 4% cottage cheese sold in Wisconsin and Illinois because the product tested positive for residue phosphatase.

    Product
    4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine brand names.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0491-2017·2016-11-30

    Infiniti Creations Recalls Believe HCG Drops Due to Misbranding

    Infiniti Creations is voluntarily recalling Believe HCG Drops due to misbranding and potential undeclared HCG content.

    Product
    Believe HCG. 2oz HCG Drops. Blue Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0483-2017·2016-11-30

    Infiniti Creations Recalls HCG Plus Drops Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Plus drops due to misbranding and potential undeclared HCG content.

    Product
    HCG Plus. 2oz HCG Drops. Blue Glass
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0627-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic ori
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0625-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 14 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic o
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-1045-2017·2016-11-30

    West-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure

    West-Ward Pharmaceuticals is recalling specific lots of Phenobarbital Tablets because they failed to meet dissolution specifications at the 12-month stability time point.

    Product
    PHENOBARBITAL — PHENOBARBITAL (PHENOBARBITAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0494-2017·2016-11-30

    Infiniti Creations Recalls HCG Diet Plan Drops Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Diet Plan drops due to misbranding and potential undeclared HCG content.

    Product
    Official HCG Diet Plan. 1oz, 2oz & 4oz HCG Drops. Amber Plastic and Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic or
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0152-2017·2016-11-30

    Akorn Recalls Desoximetasone Ointment for Stability Failures

    Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.

    Product
    Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0499-2017·2016-11-30

    Infiniti Creations Recalls Amino Complex Formula Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling Amino Complex Formula HCG Drops due to misbranding and potential undeclared HCG.

    Product
    Amino Complex Formula. 2oz HCG Drops. Blue Glass.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2017·2016-11-30

    Actavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets

    Actavis Elizabeth LLC is recalling Nifedipine Capsules USP, 10 mg, because the product may contain foreign tablets or capsules.

    Product
    NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0629-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic o
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0636-2017·2016-11-30

    Pentax Video Colonoscope Recall for Missing Operation and Reprocessing Instructions

    Pentax of America is recalling video colonoscopes shipped between April 2014 and September 2015 because they included outdated instruction manuals and lacked required reprocessing adaptors.

    Product
    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2017·2016-11-30

    Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.

    Product
    2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0493-2017·2016-11-30

    Infiniti Creations Recalls HCG Complex Drops for Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Complex drops due to misbranding and potential undeclared HCG content.

    Product
    HCG Complex. 2oz HCG Drops. Blue Plastic.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0482-2017·2016-11-30

    Infiniti Creations Recalls Simeons Program HCG Drops for Misbranding

    Infiniti Creations, LLC is voluntarily recalling Simeons Program HCG Drops due to misbranding and potential undeclared HCG content.

    Product
    Simeons Program. 2oz HCG Drops. Amber Plastic.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2017·2016-11-30

    Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags

    Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying test results.

    Product
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2017·2016-11-30

    AHP Nifedipine Capsules Recalled for Presence of Foreign Tablets

    Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg, due to the presence of foreign tablets or capsules in the packaging.

    Product
    AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0656-2017·2016-11-30

    Synthes Flexible Shaft Orthopedic Surgical Instrument Recalled for Non-Conforming Material

    Synthes (USA) Products LLC is recalling 198 units of Flexible Shaft orthopedic surgical instruments because non-conforming material was used in their manufacture.

    Product
    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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