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.

501–600 of 802

  • HighFDA (Food)·F-0421-2017·2016-11-16

    Brownwood Farms Pear Preserves Recalled for Undeclared Milk Allergen

    Brownwood Farms is recalling Pear & Cinnamon Preserves because the product contains milk that is not declared on the label.

    Product
    Brownwood Farms Pear & Cinnamon Preserves 10oz glass bottles and 1 gallon.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2017·2016-11-16

    On the Border Blue Corn Tortilla Chips Recalled for Metal Fragments

    Truco Enterprises is recalling On the Border Blue Corn Tortilla Chips due to possible metal fragments in the corn flour.

    Product
    On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2017·2016-11-16

    Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown

    Hospira is recalling Symbiq Two Channel Infusers that may display a white screen, causing the device to stop infusion and sound an alarm, which can delay or interrupt therapy.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17033·2016-11-16

    Skidders Recalls Children's Shoes Due to Sharp Rivet Laceration Hazard

    Skidders Footwear is recalling about 5,500 children's canvas tennis shoes because sharp rivets pose a laceration hazard. Consumers should take shoes away from children and contact the company for a refund.

    Product
    Children's shoes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2017·2016-11-16

    Maquet Accessory Adapter Recalled Due to Head Rest Slipping Hazard

    Maquet Medical Systems USA is recalling Accessory Adapter part number 600525A0 because a head rest mounted to the device slipped out of the mounting rail.

    Product
    Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0369-2017·2016-11-16

    Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations

    Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.

    Product
    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0339-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz, 25 g protein. Vanilla Creme UPC (case): 8-76063-00222-6; UPC (unit): 8-76063-00202-8
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0388-2017·2016-11-16

    Akita Sumitomo Bakelite Recalls Mislabeled Sterile Electrosurgical Knives

    Akita Sumitomo Bakelite Co., Ltd. is recalling 15 units of sterile electrosurgical knives that were mislabeled as Standard type instead of Jr type-Long.

    Product
    SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0343-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Protein Shakes for Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40 14 oz;, 40 g protein Crushin' Cookies. UPC (case): 8-76063-00293-6; UPC (unit): 8-76063-00283-7
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0336-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Chocolate Protein Shakes for Premature Spoilage

    H.P. Hood is recalling Muscle Milk Chocolate protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz Chocolate, 25 g protein. UPC (case): 8-76063-00221-9; UPC (unit): 8-76063-00201-1
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0283-2017·2016-11-16

    Koffee Kup Bakery Recalls Kaiser Rolls Due to Plastic Contamination

    Koffee Kup Bakery Inc. is recalling various Kaiser Rolls because they may contain pieces of plastic. Consumers in 11 states and D.C. should stop using the product.

    Product
    Koffee Kup Kaiser Rolls: Egg, Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0338-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling specific lots of Muscle Milk protein shakes because they may have spoiled prematurely, resulting in swelled containers and foul odors.

    Product
    Muscle Milk 14 oz., 25 g protein Strawberry; UPC (case): 8-76063-00229-5; UPC (unit): 8-76063-00209-7
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0329-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Strawberry Protein Shakes for Spoilage

    H.P. Hood is recalling FitPro Go! 14oz Strawberry protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    FitPro Go! 14oz Strawberry; 35g protein UPC (Case): 8-5418200329-4; UPC (Individual): 8-5418200326-3
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0341-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk 10 oz. protein shakes in chocolate flavor due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 10 oz. 18 grams protein. Sold in 4 packs Chocolate; UPC (case): 8-76063-00271-4; UPC (unit): 8-76063-00261-5
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0340-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk Caramel Kick protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz. 25 g protein Caramel Kick UPC (case): 8-76063-00214-1; UPC (unit): 8-76063-00219-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0372-2017·2016-11-16

    Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk

    Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.

    Product
    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0333-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Due to Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 Intense Vanilla protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40 14 oz.; 40 g protein Intense Vanilla UPC Case: 8-76063-00291-2; UPC Unit: 8-76063-00281-3
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0130-2017·2016-11-16

    Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Estradiol 3 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

    Product
    Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0389-2017·2016-11-16

    Sumitomo Bakelite Electrosurgical Knives Recalled for Mislabeled Sterilization Pouches

    Akita Sumitomo Bakelite Co., Ltd. is recalling 8 units of electrosurgical knives because their sterilization pouches and cartons were mislabeled as Standard Type instead of Short type.

    Product
    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Oly
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0364-2017·2016-11-16

    FDA Adds Instructions for Use to Covidien Devon Light Glove Recall

    The FDA is adding instructions to inspect the barrier integrity of the Covidien Devon Light Glove after application. This affects sterile surgical kits distributed in the US and abroad.

    Product
    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0292-2017·2016-11-16

    Koffee Kup Bakery Recalls Plain Bulkie Rolls Due to Plastic Contamination

    Koffee Kup Bakery is recalling Big Y Plain Bulkie Rolls because they may contain plastic pieces. Consumers should check use-by dates and stop eating the product.

    Product
    Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0380-2017·2016-11-16

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size

    Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.

    Product
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit e
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0394-2017·2016-11-16

    Becton Dickinson Recalls Spinal Anesthesia Trays Containing Recalled Lidocaine

    Becton Dickinson is recalling specific BD Spinal Anesthesia Trays because they contain Hospira 5% Lidocaine HCI ampules that are subject to a separate recall.

    Product
    catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0328-2017·2016-11-16

    Rich Products Recalls Chocolate Iced Éclairs for Plastic Foreign Material

    Rich Products Corp is recalling specific lots of New York Style Chocolate Iced Éclairs due to the potential presence of plastic foreign material.

    Product
    New York Style Chocolate Iced ¿clairs under the following labels: 1) Richs New York Style Chocolate Iced ¿clairs, NET WT 8 oz (226g) (UPC Code:049800147799), 2) Bakery Fresh Goodness NY Style Chocolate ¿clairs, NET WT 8 oz (226g) (UPC Code:011110456601), 3) Food Lion NY Style Ch
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0330-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Chocolate Protein Bars Due to Spoilage

    H.P. Hood is recalling FitPro Go! 14oz Chocolate protein bars due to premature spoilage, including swelled containers and foul odor.

    Product
    FitPro Go! 14oz Chocolate; 35 g protein UPC Case: 8-5418200328-7; UPC Unit: 8-5418200324-9
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0287-2017·2016-11-16

    Koffee Kup Bakery Recalls Grinder Rolls Containing Plastic Pieces

    Koffee Kup Bakery Inc. is recalling specific packages of Grinder Rolls due to the potential presence of plastic pieces.

    Product
    Koffee Kup Grinder Rolls-white 9' and Italian 9", packaged 20.4 oz.
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0334-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Premature Spoilage

    H.P. Hood is recalling specific lots of Muscle Milk protein shakes because they may have spoiled prematurely, resulting in swelled containers and foul odors.

    Product
    Muscle Milk, 14oz ; 40 g protein Banana; UPC (case): 8-76063-00223-3 UPC (unit): 8-76063-00203-5
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0337-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk protein shakes in Cookies N Crème flavor due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz, 25 g protein Cookies N Cr¿me. UPC (case): 8-76063-00224-0; UPC (unit): 8-76063-00204-2
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0129-2017·2016-11-16

    Wells Pharmacy Recalls Testosterone Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Testosterone 12.5 mg Pellets because they were found to be superpotent or subpotent.

    Product
    Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0342-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk protein shakes because some containers swelled and had a foul odor, indicating premature spoilage.

    Product
    Muscle Milk 10 oz. 18 g protein. Sold in 4 packs Vanilla Creme UPC (case): 8-76063-00272-1; UPC (unit): 8-76063-00262-2
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0355-2017·2016-11-16

    Island Biscuit Strawberry Snacks Recalled for Undeclared Food Dyes

    Lee'S Food Corp is recalling Island Biscuit "Yum Yum - Creamy Strawberry" snacks because sampling revealed undeclared food dyes.

    Product
    Island Biscuit "Yum Yum - Creamy Strawberry" Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0132-2017·2016-11-16

    Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Estradiol 12.5 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

    Product
    Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0345-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Due to Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40 14 oz., 40 g protein; Going Bananas UPC (case): 8-76063-00294-3; UPC (unit): 8-76063-00284-4
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0379-2017·2016-11-16

    Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference

    Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.

    Product
    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2017·2016-11-16

    FDA Recalls Custom Packaging for Devon Light Gloves

    The FDA is recalling custom packaging for Devon Light Gloves due to added instructions for use regarding barrier integrity inspection.

    Product
    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 40038300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0289-2017·2016-11-16

    Koffee Kup Bakery Recalls Sweet Buns Due to Plastic Contamination

    Koffee Kup Bakery Inc. is recalling specific packages of Bar-B-Que Sweet Buns because they may contain pieces of plastic.

    Product
    Koffee Kup Bar-B-Que Sweet Buns- Plain, Corn, Sesame Seed and Wheat w/Oat Topping, packaged 8 oz.
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0363-2017·2016-11-16

    C.R. Bard Recalls X-Force Nephrostomy Balloon Dilation Catheter Kits

    C.R. Bard is recalling 192 units of X-Force Nephrostomy Balloon Dilation Catheter Kits because a contract manufacturer packaged an incorrect 30Fr sheath instead of the labeled 24Fr sheath.

    Product
    X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0368-2017·2016-11-16

    Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects

    Zimmer Biomet Surgical is recalling Air Dermatome II Handpiece loaners because the surface coating may blister, peel, or discolor over time. No injuries have been reported.

    Product
    Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2017·2016-11-16

    Baylis Medical Recalls NRG Transseptal Needles Due to Packaging Defect

    Baylis Medical Corp is voluntarily recalling NRG Transseptal Needles and RF Kits because the Tyvek packaging pouches may have integrity defects.

    Product
    NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0371-2017·2016-11-16

    Schaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders

    Schaerer Medical USA Inc is recalling four 7300 model surgical tables because defective floor locking cylinders may leak due to incorrect O-rings.

    Product
    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0346-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Chocolate Due to Premature Spoilage

    H.P. Hood is recalling Muscle Milk 100 Calorie Chocolate due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 100 Calorie 14 oz Chocolate UPC (case): 8-76063-00575-3; UPC (unit): 8-76063-00565-4
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0332-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Vanilla Protein Drinks Due to Spoilage

    H.P. Hood is recalling FitPro Go! 14oz Vanilla protein drinks due to premature spoilage, including swelled containers and foul odor.

    Product
    FitPro Go! 14oz , 35 g protein Vanilla; UPC (case) : 8-5418200327-0; UPC (unit): 8-5418200325-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0344-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Due to Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40, 14 oz.. 40 g protein; Knock Out Chocolate UPC (case): 8-76063-00290-5; UPC (unit): 8-76063-00280-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0331-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Chocolate Chip Cookies Due to Spoilage

    H.P. Hood is recalling FitPro Go! 35 g protein Chocolate Chip Cookies because some containers showed signs of premature spoilage, including swelling and foul odor.

    Product
    FitPro Go! 14oz, 35 g protein Chocolate Chip Cookies UPC(Case): 8-5418200338-6; UPC Unit: 8-5418200325-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0419-2017·2016-11-16

    Monocal Calcium and Fluoride Supplement Recalled for Excess Fluoride

    Mericon Industries is recalling Monocal Calcium & Fluoride Supplement because it contains an excess amount of fluoride.

    Product
    Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0365-2017·2016-11-16

    FDA Recalls Covidien Devon Light Glove Sub-Assembly for Added Instructions

    The FDA is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly to add instructions for use regarding barrier integrity inspection.

    Product
    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0286-2017·2016-11-16

    Koffee Kup Bakery Recalls Plain Sandwich Rolls Due to Plastic Pieces

    Koffee Kup Bakery is recalling plain sandwich rolls because they may contain plastic pieces. Consumers should check their pantries and stop eating the product.

    Product
    Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
    Category
    Food
    Distribution
    12 states
  • LowFDA (Drugs)·D-0134-2017·2016-11-16

    Taro Recalls Kamedis Dandruff Care Kits Due to Low Active Ingredient

    Taro Pharmaceuticals is recalling 17,100 kits of Kamedis Bio-Herbal Dandruff Care System because the active ingredient, zinc pyrithione, was found to be subpotent.

    Product
    Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Bot
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0328-2017·2016-11-16

    SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects

    SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.

    Product
    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Food)·F-0324-2017·2016-11-16

    Tasty Toppings Recalls Dorothy Lynch Homestyle Condiment Bottles

    Tasty Toppings Inc is recalling Dorothy Lynch Homestyle condiment bottles due to a Class III FDA recall. Consumers should return affected products to the store for a refund.

    Product
    Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case)
    Category
    Food
    Distribution
    12 states
  • LowFDA (Drugs)·D-0136-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

    Product
    Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0135-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

    Product
    Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V826000·2016-11-15

    Newmar Recalls 2016-2017 Dutch Star and Ventana Motorhomes for Fire Risk

    Newmar is recalling 370 model year 2016-2017 Dutch Star and Ventana motorhomes because a power steering hose may rub against the starter motor, causing electrical arcing and a fire risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V828000·2016-11-15

    Forest River Recalls Motorhomes and Toyhaulers Due to Ladder Hinge Defect

    Forest River is recalling specific 2013-2017 motorhomes and toyhaulers because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    FOREST RIVER — FOREST RIVER, PALOMINO, PRIME TIME FR3, COLUMBUS, XLR, SPARTAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·107-2016·2016-11-15

    Piccadilly Fine Foods Recalls Beef Shepherd's Pie for Undeclared Fish Allergen

    Piccadilly Fine Foods is recalling approximately 144 pounds of beef shepherd's pie due to misbranding and undeclared anchovies (fish) in the Worcestershire sauce.

    Product
    Piccadilly Fine Foods Recalls Beef Shepherd’s Pie Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·16V823000·2016-11-15

    KZRV Recalls 2015 Trailers Due to Ladder Hinge Separation Risk

    KZRV is recalling 2015 Venom, Inferno, Sportsmen, Sportster, MXT, and SportTrek trailers because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    KZRV — KZRV SPORTSTER, VENOM, SPORTSMEN, MXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V825000·2016-11-15

    Keystone RV Recalls Fifth Wheels Due to Ladder Hinge Defect

    Keystone RV is recalling 2015-2016 fifth wheels because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    DUTCHMEN — DUTCHMEN, KEYSTONE VOLTAGE, CARBON, FUZION, RAPTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V827000·2016-11-15

    Entegra Recalls 2017 Motorhomes Due to Throttle Wire Interference

    Entegra is recalling 2017 Aspire, Anthem, Cornerstone, and Insignia motorhomes because throttle wires may not be twisted, causing unintended acceleration or deceleration.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE, ANTHEM, ASPIRE, INSIGNIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V824000·2016-11-15

    Freightliner Trucks Recalled for Potential Tire Tread Separation

    Daimler Trucks North America is recalling 2017 Freightliner trucks because improperly cured tires may separate, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2, CASCADIA, 122SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V822000·2016-11-14

    Keystone Recalls 2017 Cougar Fifth Wheel Trailers for Propane Leak Risk

    Keystone RV Company is recalling specific 2017 Cougar fifth wheel trailers because a propane manifold may contact floor fasteners, creating a potential leak and fire hazard.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V821000·2016-11-14

    Cruiser RV Recalls Stryker Toy Haulers Due to Ladder Hinge Defect

    Cruiser RV is recalling 2015-2016 Stryker toy haulers because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    CRUISER RV — CRUISER RV STRYKER TOY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V818000·2016-11-14

    Highland Ridge RV Recalls 2016 Highlanders Due to Ladder Hinge Defect

    Highland Ridge RV is recalling 61 model year 2016 Highlander travel trailers because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V819000·2016-11-14

    Heartland Recalls 2015-2016 Trailers Due to Ladder Hinge Defect

    Heartland is recalling 2,045 travel trailers because aluminum ladder hinges may separate, causing the ladder to fall and increasing injury risk.

    Product
    HEARTLAND — HEARTLAND ROAD WARRIOR, CYCLONE, TORQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·106-2016·2016-11-12

    Schnuck Markets Recalls Undercooked Ready-to-Eat Grilled Chicken Breast Products

    Schnuck Markets is recalling approximately 62 pounds of ready-to-eat grilled chicken breast products that may be undercooked, posing a risk of bacterial pathogens.

    Product
    Schnuck Markets, Inc. SLNP — Schnuck Markets Inc. Recalls Ready-To-Eat Chicken Breast Products That May Be Undercooked
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V815000·2016-11-10

    Kia Recalls 2008-2009 Sportage Vehicles Due to Fire Risk

    Kia is recalling 2008-2009 Sportage vehicles because a wire harness cover may allow water to enter, causing corrosion and an increased risk of engine compartment fire.

    Product
    KIA — KIA SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V814000·2016-11-10

    Chrysler Recalls 2016 Dodge Durango and Jeep Grand Cherokee for Fuel Leak Risk

    Chrysler is recalling 2016 Dodge Durango and Jeep Grand Cherokee vehicles due to a potential fuel rail crossover tube defect that may cause a fuel leak and increase fire risk.

    Product
    DODGE — DODGE, JEEP DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V816000·2016-11-10

    Bentley Recalls 2017 Bentayga Vehicles for Loose Seat Mechanism Joints

    Bentley is recalling 378 model year 2017 Bentayga vehicles because seat mechanism and instrument panel joints may not have been properly tightened, increasing injury risk in a crash.

    Product
    BENTLEY — BENTLEY BENTAYGA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17030·2016-11-10

    Kichler Recalls Krystal Ice Ceiling Fixtures Due to Fire Hazard

    L.D. Kichler is recalling Krystal Ice ceiling fixtures because the included 40-watt bulbs can overheat and cause fires. Consumers should stop using the fixtures immediately.

    Product
    Krystal Ice ceiling fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17031·2016-11-10

    Kidde Recalls Combination Smoke and Carbon Monoxide Alarms Due to Failure

    Kidde is recalling about 3.6 million NightHawk combination smoke/CO alarms because they may fail to chirp at end-of-life, posing a risk of undetected fires or CO incidents.

    Product
    Kidde NightHawk combination smoke/carbon monoxide (CO) alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0322-2017·2016-11-09

    Nutrisystem Chocolate Chip Cookie Dough Bars Recalled for Listeria Risk

    Nutrisystem is recalling Chocolate Chip Cookie Dough Bars due to potential Listeria monocytogenes contamination. The product was distributed in 10 states and online.

    Product
    Chocolate Chip Cookie Dough Bar 1.6 oz, 5 count carton
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0370-2017·2016-11-09

    VitaTops Apple Crumb Recalled for Undeclared Milk Allergen

    Vitalicious Acquisition is recalling specific lots of VitaTops Apple Crumb because they contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear plastic film and sold frozen in cases of 12 units, 24 units, or variety packs. The affected lots were sold in case of 24 units per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0310-2017·2016-11-09

    Le Petit Belge Recalls Belgian Boys Mini Pancakes for Undeclared Milk

    Le Petit Belge is recalling Belgian Boys Mini Pancakes because the product contains undeclared milk, posing a risk to consumers with milk allergies.

    Product
    BELGIAN BOYS MINI PANCAKES, NET WT. 10.6 oz (300g), 36 Count, UPC 857290005204, Product of The Netherlands --- Produced exclusively for Belgian Boys, 140 Carolyn Blvd., Farmingdale, NY 11735
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0375-2017·2016-11-09

    Osage Gardens Recalls Organic Micro Greens Due to Salmonella Test

    Osage Gardens is voluntarily recalling 222 units of Organic 2oz Micro Greens after a positive test for Salmonella. The product was distributed in Colorado and Kansas.

    Product
    Organic 2oz Micro Greens. Clear Plastic Clamshell. Keep Refrigerated
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0357-2017·2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    Product
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination wit
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0374-2017·2016-11-09

    Whole Foods Asparagus Pea Salad Recalled for Undeclared Eggs

    Whole Foods Market is recalling Asparagus Pea & Ricotta Salad because it contains undeclared eggs. The product was sold in five northeastern states.

    Product
    Whole Foods Asparagus Pea & Ricotta Salad, 10 Ounces
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0337-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereUSDA FSIS·102-2016 EXP·2016-11-09

    Flavor Trade Recalls Beef Jerky Produced Without Federal Inspection

    Flavor Trade, LLC. is recalling 741 pounds of beef jerky produced without federal inspection and shipped to Kansas and Missouri.

    Product
    Flavor Trade, LLC. Recalls Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0325-2017·2016-11-09

    FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.

    Product
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0326-2017·2016-11-09

    Hill-Rom Recalls Ceiling Brackets Due to Potential Fall Hazard

    Hill-Rom is recalling 188 ceiling brackets with a larger center hole that could cause the system to fall if the safe working load is exceeded.

    Product
    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0125-2017·2016-11-09

    PharMEDium Recalls Succinylcholine Chloride Vials Due to Sterility Concerns

    PharMEDium Services is recalling specific vials of Succinylcholine Chloride because a portion of the batch was compounded outside of validated process media, raising sterility concerns.

    Product
    Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0371-2017·2016-11-09

    7-Eleven Chocolate Chunk Cookie Recalled for Undeclared Peanuts

    Glenn Wayne Wholesale Bakery is recalling 7-Eleven Fresh To Go Chocolate Chunk Cookies in New York State because they may contain undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 --
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0373-2017·2016-11-09

    7-Eleven Sugar Cookie with M&M Chocolate Candy Recalled for Undeclared Peanuts

    Glenn Wayne Wholesale Bakery Inc. is recalling 7-Eleven Fresh To Go Sugar Cookies with M&M Chocolate Candy due to undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, NET WT. 4 OZ., UPC 052548558765; Manhattan UPC: 052548570644
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0349-2017·2016-11-09

    Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk

    Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.

    Product
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Mo
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0352-2017·2016-11-09

    Medline Recalls Rigid Suction Canisters Due to Implosion Risk

    Medline Industries is recalling 7,680 Rigid Suction Canisters (2000 CC and 3000 CC) because they may implode when subjected to excessive negative pressure.

    Product
    Rigid Suction Canister 3000 CC and 2000 CC.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-0382-2017·2016-11-09

    Beverage International Recalls Nu-Quench Lime Bar Mix Due to Undeclared Dye

    Beverage International is recalling Nu-Quench Lime Bar Mix because it contains undeclared Yellow #5, a potential allergen for sensitive individuals.

    Product
    Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0339-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0311-2017·2016-11-09

    Fanega Flour Tortillas Recalled for Undeclared Wheat Allergen

    Fanega Mexican Food Products is recalling 10-inch flour tortillas sold in Arizona because they contain undeclared wheat.

    Product
    10" Flour Tortillas 12 count, Net Wt. 25oz (732g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0355-2017·2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 4
    Category
    Medical Device
    Distribution
    3 states

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