The Recall Desk

Archive

September 2017 recalls

342 recalls were announced in September 2017.

What the numbers show

Critical
24
Severe
115
High
101
Moderate
92
Low
10

Of the 342 recalls this month scored against our rubric, 7% are Critical, 34% are Severe.

1–100 of 342

  • CriticalUSDA FSIS·103-2017·2017-09-29

    Belmont Sausage Recalls Smoked Turkey Drumsticks Due to Undeclared Milk Allergen

    Belmont Sausage Co. is recalling smoked turkey drumsticks because they contain undeclared milk, a known allergen. The products were distributed nationwide via an institutional location in Michigan.

    Product
    Belmont Sausage Co. Recalls Smoked Turkey Drumstick Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V609000·2017-09-29

    Mitsubishi Recalls Outlander and Lancer Models for Defective Starter Relays

    Mitsubishi is recalling 2015-2017 Outlander, Outlander Sport, Lancer, and Lancer Evolution vehicles because defective relays may cause engine stalls, reduced power, or overheating.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT, OUTLANDER, LANCER, LANCER EVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17T016000·2017-09-29

    Max-Trac Recalls Avon Viper Stryke Tires for Tread Separation Risk

    Max-Trac is recalling specific Avon Viper Stryke tires because a tread bulge or separation could cause loss of vehicle control and increase crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V608000·2017-09-29

    Kia Recalls 2014-2016 Soul Models Due to Steering Gear Separation Risk

    Kia is recalling 2014-2016 Soul and Soul EV vehicles because a pinion plug defect may allow the pinion gear to separate, potentially causing loss of steering and increasing crash risk.

    Product
    KIA — KIA SOUL, SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V606000·2017-09-28

    Silver Eagle Vast-20W Trailer Brake Caliper Bolt Recall

    Silver Eagle is recalling 2018 Vast-20W converter dolly trailers because brake caliper bolts may not be properly torqued, risking caliper detachment and loss of braking ability.

    Product
    SILVER EAGLE — SILVER EAGLE VAST-20W
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3558-2017·2017-09-27

    Dierbergs Scampi Butter Recalled for Undeclared Fish and Shellfish Allergens

    Dierbergs Markets is recalling Scampi Butter because it contains undeclared fish and crustacean shellfish. Consumers with allergies should not consume the product.

    Product
    Scampi Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-3562-2017·2017-09-27

    Sunopta Recalls Organic Great Value Dark Sweet Cherry Products Due to Listeria

    Sunopta Grains and Foods is recalling Organic Great Value Dark Sweet Cherry Products Pitted because testing found Listeria monocytogenes in a finished product sample.

    Product
    Organic Great Value Dark Sweet Cherry Products Pitted, Net Wt 32 Oz (2 lb) 907 g, Distributed by Wal-Mart Stores, Inc. Bentonville, AR
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-3560-2017·2017-09-27

    Bravo Produce Recalls Maradol Papayas Due to Salmonella Contamination

    Bravo Produce Inc is recalling Maradol papayas due to Salmonella contamination. The product was distributed in California.

    Product
    Maradol Papaya; Frutas Selectas De Tijuana, S. DE R.L. DE, C.V. Sold in 14.00 kg/ 31 Lb. cardboard boxes.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-3557-2017·2017-09-27

    Kelejete Cranberry Raisin Energy Bar Recalled for Allergen Mislabeling

    Kelejete LLC is recalling Cranberry Raisin Jete Nutritional Energy Bars because the label failed to declare peanuts and pecans in the 'Contains' statement.

    Product
    Cranberry Raisin Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77471 4. The label is read in parts: ***Cranberry Raisin ***Jete Nutritional Energy Bar***Contains Nuts***INGREDIENTS: Peanut Butt
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-3142-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the
    Category
    Medical Device
    Distribution
    44 states
  • SevereNHTSA·17V604000·2017-09-27

    Polar Tank SRJ7 Trailer Recall for Brake Caliper Bolt Torque Issues

    Polar Tank is recalling 2018 SRJ7 trailers because brake caliper bolts may not be properly torqued, risking caliper detachment and loss of braking ability.

    Product
    POLAR TANK — POLAR TANK SRJ7 TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3143-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for th
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3140-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surger
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-1167-2017·2017-09-27

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1168-2017·2017-09-27

    Pfizer Recalls Levophed Injection Due to Sterility Assurance Concerns

    Pfizer is recalling specific lots of Levophed (norepinephrine bitartrate) injection because a damaged sterilizing filter may have compromised sterility.

    Product
    LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3139-2017·2017-09-27

    Medtronic Spine Referencing Clamp Recall for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Food)·F-3555-2017·2017-09-27

    Kelejete Dark Chocolate Energy Bar Recalled for Allergen Mislabeling

    Kelejete LLC is recalling Dark Chocolate Jete Nutritional Energy Bars because the label failed to declare peanuts and pecans in the 'Contains' statement.

    Product
    Dark Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77469 1. The label is read in parts: ***Dark Chocolate***Jete Nutritional Energy Bar***Contains Nuts***INGREDIENTS: Peanut Butter, A
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-3141-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-1175-2017·2017-09-27

    Genentech Recalls Activase Due to Cracked Sterile Water Vials

    Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.

    Product
    Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3559-2017·2017-09-27

    Dierbergs Cabernet Grille Butter Recalled for Undeclared Wheat and Soy

    Dierbergs Markets is recalling Cabernet Grille Butter because it contains undeclared wheat and soy allergens.

    Product
    Cabernet Grille Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·17E053000·2017-09-27

    Bearing Technologies Recalls Duralast Wheel Spindles for Ford Edge

    Bearing Technologies is recalling Duralast Wheel Spindles for 2007-2010 Ford Edge vehicles because oversized studs may prevent correct wheel installation, increasing crash risk.

    Product
    FORD — FORD EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3572-2017·2017-09-27

    El Chilar Whole Ginger Recalled for Undeclared Sulfites

    EL Chilar Huff is recalling El Chilar Whole Ginger because the product contains undeclared sulfites. Consumers with this product should stop using it.

    Product
    El Chilar Whole Ginger, NET WT 1.25 Oz (35g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-3556-2017·2017-09-27

    Kelejete Chocolate Jete Nutritional Energy Bar Recalled for Allergen Mislabeling

    Kelejete LLC is recalling 136 Chocolate Jete Nutritional Energy Bars because the label failed to declare peanuts and pecans in the 'Contains' statement and omitted sulfites.

    Product
    Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77467 7. The label is read in parts: ***Chocolate***Jete Nutritional Energy Bar***Contains Nuts***INGREDIENTS: Peanut Butter, Apple/Plum,
    Category
    Food
    Distribution
    5 states
  • HighUSDA FSIS·101-2017-EXP·2017-09-27

    Sausage Products Recalled for Undeclared Milk Allergen and Misbranding

    America New York RI Wang Food Group is recalling approximately 63,823 pounds of pork and beef sausage products due to misbranding and an undeclared milk allergen.

    Product
    America New York Ri Wang Food Group Co., Ltd. — America New York RI Wang Food Group Recalls Sausage Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3571-2017·2017-09-27

    Laxmi Rusks Recalled for Undeclared Soy Allergen

    House of Spices India, Inc. is recalling Laxmi Rusks because the product may contain undeclared soy. Consumers with soy allergies should not eat the product.

    Product
    Laxmi Rusks, 10.58 OZ (300 gram) bags; UPC Code: 7 23246 26482 0
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-3565-2017·2017-09-27

    Joy's Gourmet Pesto Recalled for Undeclared Milk Allergen

    Joy's International Foods is recalling Joy's Gourmet Pesto due to undeclared milk and unrecorded temperatures. Consumers should stop using the product.

    Product
    Joy's Gourmet Pesto, All Natural, Net Wt. 10 OZ. (280g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3137-2017·2017-09-27

    Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3573-2017·2017-09-27

    NOW Foods Organic Coconut Sugar Recalled for Undeclared Gluten

    NOW Foods is recalling Organic Coconut Sugar because it contains undeclared gluten despite being labeled 'Gluten Free'.

    Product
    Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a foil bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3583-2017·2017-09-27

    Cheeze Kurls Recalls Butter Popcorn for Undeclared Milk Allergen

    Cheeze Kurls is voluntarily recalling specific brands of butter popcorn due to undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    Big Win Butter Popcorn, 5 oz., Butter Popcorn Artificially Flavored; Uncle Ray's 10 oz., Gourmet Select 12 oz., Gold Emblem 5 oz., and Spartan 8 oz.
    Category
    Food
    Distribution
    12 states
  • HighCPSC·17234·2017-09-27

    DICK's Sporting Goods Recalls Fitness Gear Resistance Tubes Due to Injury Hazard

    DICK's Sporting Goods is recalling about 207,500 Fitness Gear resistance tubes because they can break and strike users. Consumers should stop using them and return them for a refund or store credit.

    Product
    Fitness Gear resistance tubes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3544-2017·2017-09-27

    San Francisco Foods Seafood Salad Recalled for Undeclared Milk Allergen

    Simply Fresh Foods is recalling San Francisco Foods Seafood Salad with Greek Yogurt because the ingredient label may fail to declare milk as an allergen.

    Product
    San Francisco Foods Seafood Salad; Deli Style Seafood Salad with Greek Yogurt; 4 x 4 oz. (113 g) cups  Net Wt. 16 oz. (1 LB) 454 g; Carton UPC bar code of 47502 19701 Single Serve Cup: UPC 47502 19001 Perishable, Keep Refrigerated. Simply Fresh Foods, Inc. Buena Park
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-3566-2017·2017-09-27

    Joy's Gourmet Garlic Joy Recalled for Undeclared Milk Allergen

    Joy's International Foods is recalling Garlic Joy Alla Vodka due to undeclared milk. Consumers should check their pantry and stop using the product.

    Product
    Joy's Gourmet Garlic Joy All Natural Alla Vodka, Sugar Free Gluten Free, Net Wt. 32 Oz. (1000g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-3561-2017·2017-09-27

    Coca-Cola Recalls Honest Kids Juice Slushy Pouches Due to Design Issue

    The Coca-Cola Company is recalling Honest Kids Juice Slushy Blueberry Punch pouches because a package design issue may cause injury when opened unevenly.

    Product
    Honest Kids Juice Slushy Blueberry Punch, 3.5-oz. pouch, UPC 0065762211116.
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·17E054000·2017-09-27

    YSN Flame King RV Outdoor Cooktop Stove Recall for Fire Risk

    YSN Imports is recalling Flame King RV outdoor cooktop stoves because an internal cover can burn if the flame inverts, increasing the risk of a fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3564-2017·2017-09-27

    Joy's Gourmet Olive Tapenade Recalled for Undeclared Milk Allergen

    Joy's International Foods is recalling 12.5 cases of Olive Tapenade with Blue Cheese due to undeclared milk and unrecorded temperatures.

    Product
    Joy's Gourmet Olive Tapenade with Blue Cheese, All Natural, Net Wt. 10 OZ. (280g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-3567-2017·2017-09-27

    Joy's Gourmet Pesto Recalled for Undeclared Milk Allergen

    Joy's International Foods is recalling Joy's Gourmet Pesto due to undeclared milk and unrecorded temperatures after thermal processing.

    Product
    Joy's Gourmet Pesto, All Natural, Net Wt. 4 OZ.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-3489-2017·2017-09-27

    Kilby Cream Recalls Birthday Cake Ice Cream Due to Temperature Deviation

    Kilby Cream is recalling Birthday Cake Ice Cream in 7 oz, Pint, and Gallon sizes because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Birthday Cake Size: 7 oz. and Gallon, Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3546-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling 2.5-gallon Ravenberry ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: Ravenberry Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3496-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling specific ice cream products because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cow Dough Size: 2.5 Gal, 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3550-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling various ice cream flavors because production and storage temperatures were not properly maintained.

    Product
    Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1169-2017·2017-09-27

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 321,900 Daytrana patches because the delivery system no longer meets release liner removal specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3513-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Control Failures

    Kilby Cream is recalling various ice cream flavors due to a process deviation where proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: Pretzel Ball Size: 2.5 Gal , 7 oz., Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3497-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Cowconut ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cowconut Size: 2.5 Gal, Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3498-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling 2.5-gallon pints of Crow Vineyard Rose ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Crow Vineyard Rose Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3502-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling 2.5-gallon Java Chip ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Java Chip Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3508-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviation

    Kilby Cream is recalling Minty Moo ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Minty Moo Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3500-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviation During Production

    Kilby Cream is recalling Independence Explosion ice cream in 2.5-gallon and 7-ounce sizes because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Independence Explosion Size: 2.5 Gal, 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1174-2017·2017-09-27

    Medisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations

    Medisca, Inc. is recalling Aminocaproic Acid API lots because the product was manufactured for industrial use but labeled for pharmacy compounding.

    Product
    Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3136-2017·2017-09-27

    Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.

    Product
    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3552-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling various ice cream flavors due to a process deviation where proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: , Tracker Tracks Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3510-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling Oriole Chip ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Oriole Chip Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3563-2017·2017-09-27

    Handsome Brook Farm Organic Eggs Recalled for Potential Mold Contamination

    Handsome Brook Farm is recalling 15,975 dozen organic pasture-raised eggs due to potential mold contamination. The product was distributed in Rhode Island, Illinois, Arizona, and Ohio.

    Product
    Handsome Brook Farm Soy-Free Organic Pasture-Raised Eggs, UPC 8-66332-00011-4. The product is packaged in a tan, paper pulp egg carton with a bright pink label.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-3548-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling 2.5-gallon Snickers ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: Snickers Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3491-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling Black Raspberry Ice Cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Black Raspberry Size: 7 oz. and Gallon, Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3569-2017·2017-09-27

    Joy's Gourmet Olive Salad Recalled for Unrecorded Temperature Data

    Joy's International Foods is recalling 16 cases of Joy's Gourmet Olive Salad because temperature records were missing after thermal processing.

    Product
    Joy's Gourmet Olive Salad, All Natural, Net Wt. 10 OZ. (280g).
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-3511-2017·2017-09-27

    Kilby Cream Peach Ice Cream Recalled for Temperature Deviation

    Kilby Cream is recalling 2.5-gallon containers of Peach Ice Cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Peach Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3553-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Production Temperature Deviations

    Kilby Cream is recalling various ice cream flavors due to a process deviation where proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: , Vanilla Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3488-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Almond Delight ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Almond Delight Size: 7 oz. and Gallon
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3494-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling 2.5-gallon Cappuccino ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Cappuccino Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3554-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Control Failures

    Kilby Cream is recalling various ice cream flavors because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: , Vanilla Chip Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3138-2017·2017-09-27

    Kamiya Biomedical Recalls K-Assay Multi-Analyte Calibrator Due to Incorrect Values

    Kamiya Biomedical is recalling specific lots of the K-Assay Multi-Analyte Calibrator because the Alpha-1 Antitrypsin (AlAT) values listed in the package insert were incorrect.

    Product
    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Hap
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Food)·F-3499-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Production Temperature Deviations

    Kilby Cream is recalling 37 units of Holstein Cream ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Holstein Cream Size: 2.5 Gal, 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3568-2017·2017-09-27

    Joy's Gourmet Olive Tapenade Recalled for Unrecorded Temperatures

    Joy's International Foods is recalling 36.5 cases of Joy's Gourmet Olive Tapenade because temperatures were not recorded after thermal processes.

    Product
    Joy's Gourmet Olive Tapenade, All Natural, Net Wt. 10 OZ. (280g).
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-3492-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling Butter Pecan ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Butter Pecan Size: 7 oz. and Gallon, Pint
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3503-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Jersey Swirl ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Jersey Swirl Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3507-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Mint Mookie ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Mint Mookie Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3509-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Production Temperature Deviations

    Kilby Cream is recalling specific sizes of Mootella ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Mootella Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3501-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviation

    Kilby Cream is recalling 2.5-gallon Island Breeze ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Island Breeze Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1165-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Bags Due to Expired Diluent

    PharMEDium Services is recalling 590 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3547-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Deviations

    Kilby Cream is recalling 2.5-gallon S'mores ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: S'mores Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1166-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Due to Expired Diluent

    PharMEDium Services is recalling 295 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3549-2017·2017-09-27

    Kilby Cream Ice Cream Recalled for Temperature Control Failures

    Kilby Cream is recalling various flavors of ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream Various Flavors: Strawberry Size: 2.5 Gal , 7 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-3134-2017·2017-09-27

    BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures

    BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.

    Product
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growt
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-3506-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviations

    Kilby Cream is recalling Maryland Madness ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Maryland Madness Size: 2.5 Gal
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-3570-2017·2017-09-27

    Joy's Gourmet Artichoke Salad Recalled for Unrecorded Temperatures

    Joy's International Foods is recalling Joy's Gourmet Artichoke Salad due to unrecorded temperatures after thermal processes.

    Product
    Joy's Gourmet Artichoke Salad, All Natural, Net Wt. 10 OZ. (280g).
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-1163-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures

    Pfizer is recalling 14,712 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1164-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure

    Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·17233·2017-09-26

    Saber Grills Recalls Gas Grills and LP Regulators Due to Fire Hazards

    Saber Grills is recalling gas grills and LP regulators because a malfunctioning regulator can cause gas leaks and flame bursts, posing fire and burn risks.

    Product
    Gas grills and liquid propane (LP) regulators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V601000·2017-09-26

    RAM ProMaster City Recalled for Incorrect Tire Placard Information

    Chrysler is recalling 2015-2017 RAM ProMaster City vehicles because the tire placard contains incorrect weight, occupant, and pressure data, which may increase crash risk.

    Product
    RAM — RAM PROMASTER CITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V594000·2017-09-25

    Ford Recalls 2015 F-650 and F-750 Trucks for Steering Defect

    Ford is recalling 2015 F-650 and F-750 trucks because a steering component may loosen, potentially causing a loss of steering control.

    Product
    FORD — FORD F-750 SD, F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V598000·2017-09-25

    Ford Recalls 2018 F-150 Raptors for Missing Roof Rivets

    Ford is recalling 2018 F-150 Raptor Super Cab trucks without moonroofs because missing roof rivets may reduce structural integrity, increasing injury risk in rollovers.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide

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