The Recall Desk

Archive

November 2017 recalls

629 recalls were announced in November 2017.

What the numbers show

Critical
72
Severe
168
High
284
Moderate
80
Low
25

Of the 629 recalls this month scored against our rubric, 11% are Critical, 27% are Severe.

101–200 of 629

  • HighFDA (Devices)·Z-0114-2018·2017-11-29

    3M Recalls Bair Hugger Temperature Sensors Due to Programming Error

    3M is recalling Bair Hugger temperature sensors because a programming error may cause the device to display a temperature lower than the patient's actual body temperature.

    Product
    3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0322-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Cranberry for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling multiple Dark Chocolate Cranberry products because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Cranberry, 20 lbs., 25 lbs., 8/8 oz., 8 pc. display, 18/12 oz., 15 lbs., 2 NDS,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0113-2018·2017-11-29

    Medline Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.

    Product
    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0315-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Blueberries for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Blueberries because they may contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Dark Chocolate Blueberries 8/7 oz., 8 pc. display, 25 lbs.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0337-2018·2017-11-29

    Astor Chocolate Recalls Dark Chocolate Covered Cranberries for Undeclared Milk

    Astor Chocolate Corporation is recalling Dark Chocolate Covered Cranberries due to an undeclared milk allergen. The product was distributed across multiple US states and Canada.

    Product
    Astor Chocolate Corporation Brand Dark Chocolate Covered Cranberries in Astor or Customer Logo packaging a. 1 oz. giveaway type package sizing b. 4 oz. giveaway type package sizing c. No best by date on units d. Individual cases sold to Astor branded customers i. Case c
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0162-2018·2017-11-29

    Medline Recalls Sensicare Green Surgical Gloves Due to Potential Sterility Breach

    Medline Industries is recalling 8,000 units of Sensicare Green Surgical Gloves because a possible open seal on the packaging could compromise sterility.

    Product
    Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Food)·F-0373-2018·2017-11-29

    Henning's Wisconsin Cheese Colby Jack Recalled Due to Pasteurization Record Failure

    Henning Cheese, Inc. is recalling 4,253 lbs of Colby Jack cheese because a temperature recorder failed to log pasteurization data for the first vat.

    Product
    Henning's Wisconsin Cheese Colby Jack, Colby & Monterey Jack Blended Together. Packaged in 1 lb., 2 lb, and mammoth wheels (A mammoth wheel can be classified as anything 75 lbs. and larger).
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0380-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Crazy Bread Kits for Physical Contaminants

    Champion Foods is recalling Little Caesar's Crazy Bread Kits due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Crazy Bread Kits, Paper cartons, Contains: 3 bread crusts (18 pcs.), 3 packages of Garlic Buttery Sauce, 3 packets of Parmesan cheese, 3 packets of Crazy Sauce
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0161-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Software

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.

    Product
    ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0169-2018·2017-11-29

    Resource Optimization Recalls Regard Custom Surgical Packs Due to Label Error

    Resource Optimization & Innovation LLC is recalling 51 units of Regard Custom Surgical Packs because they contain a 3ml ChloraPrep With Tint unit with an incorrect label.

    Product
    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0087-2018·2017-11-29

    FDA Recalls Extra Strength PreTAT Gel Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel because of inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0085-2018·2017-11-29

    Lorazepam Tablets Recalled Due to Incorrect Strength Labeling

    Leading Pharma, LLC is recalling Lorazepam tablets labeled as 0.5 mg but containing 1 mg. The recall addresses a labeling error affecting 2,952 bottles nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2018·2017-11-29

    Abbott Clinical Chemistry Systems Recalled for Tubing Leak Risk

    Abbott is recalling 34 ARCHITECT c4000, c8000, and c16000 clinical chemistry systems because a manufacturing issue with the peristaltic head tubing may cause leaks.

    Product
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0088-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Spray for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Spray due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally H
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0083-2018·2017-11-29

    United Therapeutics Recalls Tyvaso Inhalation Devices Due to Manufacturing Deviations

    United Therapeutics is voluntarily recalling 12 Tyvaso Inhalation System Starter Kits due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0375-2018·2017-11-29

    Champion Foods Recalls Cheesy Breadsticks Due to Potential Ink Pen Contamination

    Champion Foods is voluntarily recalling frozen Cheesy Breadsticks and other bread products due to potential physical contaminants from an ink pen.

    Product
    Cheesy Breadsticks, 9.98 oz. 24 or 25 units per case, or 22.75 oz. 12 units per case, frozen
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0090-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Balm for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Balm due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0379-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Italian Cheese Bread Kits

    Champion Foods is recalling Little Caesar's Italian Cheese Bread Kits due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Italian Cheese Bread Kits, Paper cartons, Contains: 3 square bread crusts (10 inches), 3 packages of Garlic Butter sauce, 3 packages of cheese, 3 packages of Italian Seasoning
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0168-2018·2017-11-29

    Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy

    Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.

    Product
    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the ph
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0378-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Pizza Kits Due to Ink Pen Contamination

    Champion Foods is recalling Little Caesar's DEEP!DEEP! Dish Kits and other bread products due to potential ink pen contamination from a supplier.

    Product
    Little Caesar's DEEP!DEEP! Dish Kits, Paper cartons, Contains: 4 pizza crusts ( 9.5 inches x 6 inches), 4 packages of pizza sauce, 4 package of cheese, 1 re-sealable package of pepperoni, 4 trays
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0089-2018·2017-11-29

    Ridge Properties Recalls Naturally HL Hemorrhoid Gel Due to Manufacturing Issues

    Ridge Properties, LLC is recalling Naturally HL Liquid Hemorrhoid Relief Gel due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Natu
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0084-2018·2017-11-29

    FDA Recalls Unapproved Faiza Beauty Cream Distributed in New York

    The FDA is recalling No. 1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0086-2018·2017-11-29

    Ridge Properties Recalls Bed Sore Cream Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine due to inadequate manufacturing control processes.

    Product
    Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0377-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Meal Kits Due to Ink Pen Contamination

    Champion Foods is voluntarily recalling Little Caesar's Family Meal Kits and other bread products due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Family Meal Kits, Paper cartons, Contains: 1 pizza crust( 12 x 16), 1 package of pizza sauce, 1 package of cheese, 1 package of pepperoni, 1 Crazy bread Cust (18 pc), 1 packet of garlic buttery sauce, 1 packet of parmesan cheese, and 15 break n bake chocolate chip
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-0093-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurities

    West-Ward Pharmaceuticals is recalling specific lots of Dexamethasone Sodium Phosphate Injection because of high out-of-specification results for a related compound.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0094-2018·2017-11-29

    West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity

    West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection due to high levels of a related compound impurity.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·17V761000·2017-11-27

    Daimler Recalls 2008-2018 Trucks for Brake Light Switch Defect

    Daimler Trucks North America is recalling 2008-2018 Freightliner and Western Star trucks because the brake light switch may fail to activate lights after hard braking, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 5700, 4900, 4700, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0248-2018·2017-11-22

    Meijer Recalls Salad Rotini Mozzarella Medley Due to Listeria Risk

    Meijer is voluntarily recalling specific salad rotini products due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including: Markets of Meijer SALAD ROTINI MOZZARELLA MEDLEY, Markets of Meijer SALAD ROTINI MOZZARELLA MEDLEY G&G
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0367-2018·2017-11-22

    Texas Roadhouse Barbecue Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc is recalling Texas Roadhouse Barbecue Sauce because it may contain undeclared egg. The product was distributed to distributors in 12 states.

    Product
    Texas Roadhouse Barbecue Sauce, NET 3/2 gallon, Mfg. exclusively for: Texas Roadhouse Restaurants, Louisville, KY, packaged in plastic pouches.
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0365-2018·2017-11-22

    West Creek BBQ Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc. is recalling West Creek Original BBQ Sauce because it may contain undeclared egg.

    Product
    West Creek Original BBQ Sauce, Net Contents 1 Gal, Distributed by Performance Food Group, Richmond, VA packaged in plastic jugs.
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0247-2018·2017-11-22

    Meijer Recalls Cauliflower Florets Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling specific cauliflower floret products due to potential Listeria monocytogenes contamination identified by a supplier.

    Product
    Vegetable products including: CAULIFLOWER FLORETS 3 LB BAG CAULIFLOWER FLORETTS (EDI) CAULIFLOWER FLORETTS CAULIFLOWER FLORETS PLU 4566 PRE-PACKAGED CAULIFLOWER FLORETS CAULI FLORETS 3 LB BAG CAULIFLOWER FLORETTS LB
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0253-2018·2017-11-22

    Meijer Recalls Mixed Pepper Blend Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling mixed pepper blend and other vegetable products due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including: MIXED PEPPER BLEND
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0081-2018·2017-11-22

    Llorens Pharmaceutical Recalls Urin D/S Tablets Due to Potency Issues

    Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.

    Product
    Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0080-2018·2017-11-22

    PharMEDium Recalls Hydromorphone Injection Due to Potency Failure

    PharMEDium Services is recalling 499 syringes of Hydromorphone HCl injection because the product failed potency specifications.

    Product
    Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0076-2018·2017-11-22

    Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    Amneal Pharmaceuticals is recalling 14,000 vials of Fosphenytoin Sodium Injection because of the presence of particulate matter.

    Product
    Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-0256-2018·2017-11-22

    Meijer Recalls Vegetable Trays Due to Listeria Contamination Risk

    Meijer is voluntarily recalling Large, Medium, and Small Veggie Trays due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including:Large Veggie Tray Medium Veggie Tray Small Veggie Tray
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0255-2018·2017-11-22

    Meijer Recalls Vegetable Trays with Hummus Due to Listeria Risk

    Meijer is voluntarily recalling fresh vegetable trays with hummus due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including: Fresh Vegetable Tray with HUMMUS
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0249-2018·2017-11-22

    Meijer Recalls Asparagus Products Due to Listeria Contamination Risk

    Meijer is voluntarily recalling asparagus products due to potential Listeria monocytogenes contamination identified by a supplier.

    Product
    Vegetable products including: ASPARAGUS SPEARS & ASPARAGUS SPEARS WITH GARLIC PARMESAN
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0254-2018·2017-11-22

    Meijer Recalls Vegetable Products Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling specific vegetable products, including a Fiesta Tray with Red Pepper Hummus, due to potential Listeria monocytogenes contamination.

    Product
    Vegetable products including: FIESTA TRAY WITH RED PEPPER HUMMUS
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0244-2018·2017-11-22

    Etai's Recalls Veggie Wrap and Caprese Panini for Undeclared Tree Nuts

    Etai's Food, Inc. is recalling specific lots of Veggie Wrap and Caprese Panini due to undeclared tree nuts, posing a risk to consumers with allergies.

    Product
    Veggie Wrap, Net Wt: 8 oz/227g, UPC 7 62089 10655 3, Etai's, individual plastic container, keep under refrigeration
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0366-2018·2017-11-22

    CFS West BBQ Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc is recalling BBQ Sauce packed for Carl's Jr. and Hardee's because it may contain undeclared egg.

    Product
    BBQ Sauce, 200/0.88 oz Net Wt 11 lbs, Packed exclusively for Carl's Jr. Restaurants LLC, Hardee's Restaurants LLC, Carpinteria, CA. Packed packaged in plastic cups.
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0246-2018·2017-11-22

    Meijer Recalls Broccoli Florets Due to Listeria Contamination Risk

    Meijer is voluntarily recalling specific broccoli floret products due to potential Listeria monocytogenes contamination identified by a supplier.

    Product
    Vegetable products including: BROCCOLI FLORETS 3 LB BROCCOLI FLORETS LB BROCCOLI FLORETS PLU 4548 PRE-PACKAGED BROCCOLI FLORETS BROCCOLI FLORETS 3 LB BAG
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0101-2018·2017-11-22

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 21,461 Plum 360 Infusion Systems because a software defect can prevent users from stopping the pump or restarting delivery under specific conditions.

    Product
    Plum 360 Infusion System, List number 30010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0213-2018·2017-11-22

    BrightFarms Spring Mix Recalled for Potential E. coli Presence

    CHI Greenhouse is voluntarily recalling BrightFarms Spring Mix packages due to the potential presence of E. coli. The recall covers products distributed in Illinois and Wisconsin.

    Product
    BrightFarms Spring Mix (4 oz. and 8 oz., 3# packages);
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0371-2018·2017-11-22

    Meijer Recalls Dark Chocolate Coffee Beans for Undeclared Milk Allergen

    Meijer is voluntarily recalling dark chocolate coffee beans, almonds, and cashews due to undeclared milk.

    Product
    Dark chocolate covered coffee beans MEIJER BULK DARK CHOCOLATE COFFEE BEANS 18 OZ Clear plastic clam-shell, 12 packages per case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0214-2018·2017-11-22

    BrightFarms Spinach Blend Recalled for Potential E. coli Presence

    CHI Greenhouse is voluntarily recalling BrightFarms Spinach Blend due to the potential presence of E. coli. The product was distributed in Illinois and Wisconsin.

    Product
    BrightFarms Spinach Blend (4 oz. package)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0099-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Devices Due to Observed Instability

    Zimmer Biomet is recalling 53 ROSA Surgical Devices because of observed instability. The devices are computer-controlled arms used in neurosurgery.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0348-2018·2017-11-22

    Uncle Buck's Dark Chocolate Peanuts Recalled for Undeclared Milk Allergen

    Ruckers Makin Batch Candies is recalling Uncle Buck's and Family Choice Dark Chocolate Peanuts due to undeclared milk. The voluntary recall affects 1,944 units distributed in 21 states.

    Product
    dark chocolate peanuts, 8.5 oz.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0395-2018·2017-11-22

    doTERRA Recalls Slim & Sassy TrimShake for Undeclared Milk Allergen

    doTERRA is voluntarily recalling Slim & Sassy TrimShake mixes because they contain an undeclared milk allergen.

    Product
    Slim & Sassy¿ TrimShake Vanilla, SKU 35180001, 1 lb 5.9 oz, HDPE tub
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·17V752000·2017-11-22

    Entegra Recalls 2010-2011 RVs Due to Fire Extinguisher Defect

    Entegra is recalling 2010-2011 Aspire, Anthem, and Cornerstone RVs because the installed fire extinguishers may clog, require excessive force to activate, or have nozzles that detach.

    Product
    ENTEGRA — ENTEGRA ASPIRE, CORNERSTONE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0343-2018·2017-11-22

    Setton Farms Dark Chocolate Almonds Recalled for Undeclared Milk

    Setton International Foods is recalling Setton Farms Deluxe Dark Chocolate Almonds because the product contains undeclared milk. This poses a risk to individuals with milk allergies.

    Product
    (1)Setton Farms Deluxe Dark Chocolate Almonds 20oz. plastic tubs UPC: 034325078741 (2) Setton Farms Deluxe Dark Chocolate Almonds 14oz . plastic stubs UPC:034325747661
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·17E071000·2017-11-22

    Prevost Recalls Commercial Bus Driver Seats Due to Stuck Seat Belt Buckles

    Prevost is recalling specific aftermarket commercial bus driver seats because the seat belt buckle may be stuck in the locked position, preventing the seat belt from latching.

    Product
    SEAT BELTS:FRONT:BUCKLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V751000·2017-11-22

    Cruiser RV Recalls Vehicles with Defective Kidde Fire Extinguishers

    Cruiser RV is recalling specific recreational vehicles equipped with certain Kidde fire extinguishers that may clog or have nozzles detach, posing injury risks during a fire.

    Product
    CRUISER RV — CRUISER RV MPG, LIBERTY, LAND ROAMER, FUN FINDER XTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V758000·2017-11-22

    Thor Motor Coach Recalls RVs with Defective Kidde Fire Extinguishers

    Thor Motor Coach is recalling 2003-2018 recreational vehicles equipped with specific Kidde fire extinguishers that may clog or detach, increasing injury risk during a fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MOTOR, THOR MAGELLAN, HURRICANE, GEMINI, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0212-2018·2017-11-22

    BrightFarms Basil Recalled Due to Potential E. coli Presence

    CHI Greenhouse is voluntarily recalling specific packages of BrightFarms basil due to the potential presence of E. coli.

    Product
    BrightFarms Basil (.75 oz. and 2 oz. package); BrightFarms Thai Basil (.75 oz. package); and BrightFarms Lemon Basil (.75 oz. package)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0356-2018·2017-11-22

    Dark Chocolate Almonds Recalled for Undeclared Milk Allergen

    DSD Merchandiser Inc. is recalling Dark Chocolate Almonds due to undeclared milk, a major food allergen. The product was distributed in California, Arizona, and Oregon.

    Product
    Dark Chocolate Almonds; Packaged in 11 oz. pre-packed plastic cups; UPC: 6-51433-66300-5 Also sold in 20 lb. bulk. Sold in bulk bins at Albertsons/Safeway/Vons/Pak 'N Save) - PLU 21881; UPC: 6-51433-10004-3 Bulk bins at Nugget Markets - PLU 6630; UPC: 6-51433-10004-3 In
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0218-2018·2017-11-22

    BrightFarms Baby Romaine Mix Recalled Due to Potential E. coli Presence

    CHI Greenhouse is voluntarily recalling BrightFarms Baby Romaine Mix packages due to the potential presence of E. coli. The recall covers 3,285 cases distributed in Illinois and Wisconsin.

    Product
    BrightFarms Baby Romaine Mix (4 oz. package)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0102-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift

    Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.

    Product
    ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0216-2018·2017-11-22

    BrightFarms Baby Kale Recalled for Potential E. coli Presence

    CHI Greenhouse is voluntarily recalling BrightFarms Baby Kale due to the potential presence of E. coli. The product was distributed in Illinois and Wisconsin.

    Product
    BrightFarms Baby Kale (3 oz. package)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0369-2018·2017-11-22

    Meijer Recalls Bulk Dark Chocolate Almonds, Cashews, and Coffee Beans

    Meijer is voluntarily recalling specific bulk dark chocolate products due to undeclared milk, a common allergen.

    Product
    MEIJER BULK DARK CHOCOLATE ALMONDS 18 OZ, Clear plastic clam-shell,12 packages per case
    Category
    Food
    Distribution
    6 states
  • HighCPSC·18703·2017-11-22

    Goal Zero Recalls Solar Charging Stations Due to Impact Hazard

    Goal Zero is recalling Street Charge solar powered charging stations because a weld failure could cause the top post to fall, posing an impact hazard.

    Product
    Street Charge solar powered mobile device charging stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0245-2018·2017-11-22

    Nature's Touch Frozen Organic Whole Beans Recalled for Listeria

    Nature's Touch US frozen Organic Whole Beans are being recalled because Listeria monocytogenes was found in a sample. The product was distributed in New Jersey, New Hampshire, and Massachusetts.

    Product
    Nature's Touch US frozen Organic Whole Beans, 10-oz., UPC code 8 7366800141
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0344-2018·2017-11-22

    Setton Farms Dark Chocolate Raisins Recalled for Undeclared Milk

    Setton International Foods Inc is recalling Setton Farms Deluxe Dark Chocolate Raisins because the product contains undeclared milk.

    Product
    (1) Setton Farms Deluxe Dark Chocolate Raisins 24oz. plastic tub UPC:034325078758 (2) Setton Farms Deluxe Dark Chocolate Raisins 16oz.. plastic tub UPC:034325147669
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0090-2018·2017-11-22

    WalkMed Infusion Pump Reservoir Bags Recalled for Fluid Leaks

    WalkMed, LLC is recalling 25,920 infusion pump reservoir bags due to reported fluid leaks at the luer connection.

    Product
    Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V754000·2017-11-22

    Bison Recalls 2010 Recreational Trailers Due to Fire Extinguisher Defect

    Bison Coach is recalling 2010 Stratus, Aluma Sport, Trail Express, and Trail Hand trailers because their fire extinguishers may clog or detach, posing injury risks.

    Product
    BISON — BISON STRATUS, TRAIL HAND, ALUMA SPORT, TRAIL EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0340-2018·2017-11-22

    Aurora Dark Chocolate Cranberries Recalled for Undeclared Milk

    Aurora Products is recalling Dark Chocolate Cranberries because the product contains undeclared milk, a major food allergen.

    Product
    Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Plastic Cup 4.75 oz. Plastic Pouch 9 oz. Plastic Cup 9 oz. Plastic Pouch 11 oz. Square Plastic Tub 18 oz. Family Size Plastic Pouch 26 oz. Plastic Tray Aurora Brand and Store Branded Labeling Include: AG Superma
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0341-2018·2017-11-22

    Aurora Dark Chocolate Coffee Beans Recalled for Undeclared Milk

    Aurora Products is recalling Dark Chocolate Coffee Beans in various package sizes due to undeclared milk. The recall covers products distributed nationwide and in Bermuda.

    Product
    Dark Chocolate Coffee beans packaged in Bulk 4 oz. Plastic Pouch 8.25 oz. Plastic Pouch 8.25 oz. Plastic Cup 17 oz. Family Size Plastic Pouch Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Deciccos, Grauls Market, Go
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2018·2017-11-22

    Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

    Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagen
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0100-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Optical Sensor Failure

    Zimmer Biomet is recalling 14 ROSA Surgical Devices because a cable disconnection may cause the optical distance sensor to fail.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0342-2018·2017-11-22

    Aurora Dark Chocolate Almonds Recalled for Undeclared Milk

    Aurora Products is recalling Dark Chocolate Turbinado Almonds with Sea Salt because the product contains undeclared milk. The recall affects 1,128 units distributed nationwide and in Bermuda.

    Product
    Dark Chocolate Turbinado Almonds w/ Sea Salt packaged in : 7 oz. Plastic Cup Packaged under the following: Aurora Brand and Store Branded Labeling Include: Gourmet Garage, Lee's Supermarket
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0339-2018·2017-11-22

    Aurora Dark Chocolate Cherries Recalled for Undeclared Milk

    Aurora Products is recalling Dark Chocolate Cherries in 8.5 oz cups and 11 oz tubs due to undeclared milk.

    Product
    Aurora Brand Dark Chocolate Cherries packaged in: 8.5 oz. Plastic Cup 11 oz. Square Plastic Tub
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2018·2017-11-22

    Zimmer Biomet ROSA Surgical Device Recalled for Potential Force Sensor Break

    Zimmer Biomet is recalling 21 ROSA Surgical Devices due to a possible break in the Force Sensor connector. The devices were distributed to facilities in Ohio, Michigan, and Texas.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V765000·2017-11-22

    KME Fire Trucks Recalled for Pressure Valve Defect

    KME is recalling 74 fire trucks because corroding rings may cause pressure relief valves to open, reducing water pressure for firefighting.

    Product
    KME — KME PREDATOR SS TANKER, PREDATOR SS PUMPER, PREDATOR SS AERIAL, COMMERCIAL PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0363-2018·2017-11-22

    Monarch Worcestershire Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc. is recalling Monarch Worcestershire Sauce because it may contain undeclared egg. The product was distributed to distributors in 12 states.

    Product
    Monarch Worcestershire Sauce, Net 1 gallon, Distributed by US Foods, Inc. Rosemont, IL, packaged in plastic jugs.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0338-2018·2017-11-22

    Aurora Dark Chocolate Almonds Recalled for Undeclared Milk

    Aurora Products is recalling Dark Chocolate Almonds nationwide and in Bermuda because the product contains undeclared milk.

    Product
    Dark Chocolate Almonds packaged in: 4 oz. Plastic Pouch, 9 oz. Plastic Cup, 9 oz. Stand Up Plastic Pouch, 12 oz. Square Plastic Tub, 17 oz. Family Size Plastic Pouch. Aurora Brand and Store Branded Labeling Include: AG Supermarkets, Belmont Market, Boiceville Market, Dec
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0364-2018·2017-11-22

    West Creek Sweet BBQ Sauce Recalled for Undeclared Egg

    CFS West Holdings Inc. is recalling West Creek Sweet BBQ Sauce because it may contain undeclared egg, a major food allergen.

    Product
    West Creek Sweet BBQ Sauce, Net Contents 1 Gal, Distributed by Performance Food Group, Richmond, VA packaged in plastic jugs.
    Category
    Food
    Distribution
    12 states
  • HighNHTSA·17V756000·2017-11-22

    Forest River and Coachmen Recalling RVs with Defective Fire Extinguishers

    Forest River is recalling 2003-2018 motorhomes and trailers equipped with certain Kidde fire extinguishers that may clog or detach, increasing injury risk during a fire.

    Product
    CONTINENTAL CARGO — CONTINENTAL CARGO, FOREST RIVER, COACHMEN CONTINENTAL CARGO, MOBILE RESTROOM, XLR, CEDAR CREEK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V753000·2017-11-22

    DRV Recalls RVs with Defective Kidde Fire Extinguishers

    DRV Suites is recalling specific recreational vehicles equipped with certain Kidde fire extinguishers that may clog, require excessive force to activate, or have nozzles that detach.

    Product
    DRV — DRV MOBILE SUITE, MOBILE SUITE ESTATES, SELECT, TRADITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V755000·2017-11-22

    Keystone Recalls Recreational Trailers with Defective Kidde Fire Extinguishers

    Keystone RV is recalling 2003-2018 Crossroads, Dutchmen, and Keystone trailers because the installed Kidde fire extinguishers may clog or detach, posing injury risks during a fire.

    Product
    DUTCHMEN — DUTCHMEN, KEYSTONE, CROSSROADS FREEDOM SPIRIT, EXPRESS, ECO, DUTCHMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0394-2018·2017-11-22

    doTERRA Recalls Slim & Sassy TrimShake for Undeclared Milk Allergen

    doTERRA is voluntarily recalling Slim & Sassy TrimShake chocolate and vanilla mixes because they contain an undeclared milk allergen.

    Product
    Slim & Sassy¿ TrimShake Chocolate, SKU 35200001, 1 lb 5.9 oz, HDPE tub
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0334-2018·2017-11-22

    Giant Eagle Recalls Breaded Shrimp for Undeclared Egg Allergen

    Giant Eagle is voluntarily recalling Breaded Shrimp sold in prepared foods sections due to an undeclared egg allergen.

    Product
    Giant Eagle Breaded Shrimp Pittsburgh, PA 15238 PLU # 86815 refrigerated, packed in plastic clam shell. Sell by dates: up to and including Oct 25 2017. Located in the Grab "n Go refrigerated cases at Giant Eagle and Market District supermarkets.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0243-2018·2017-11-22

    Etai's Recalls Caprese Panini and Veggie Wrap for Undeclared Tree Nuts

    Etai's Food, Inc. is recalling Caprese Panini and Veggie Wrap products due to undeclared tree nuts, a potential allergen hazard.

    Product
    Caprese Panini, Net WT: 7 oz/198g, UPC 7 62089 10728 4, Etai's, individual plastic container, keep under refrigeration
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0252-2018·2017-11-22

    Meijer Recalls Zucchini Squash Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling zucchini squash and other vegetable products due to potential Listeria monocytogenes contamination.

    Product
    Vegetable products including: ZUCCHINI SQUASH
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0251-2018·2017-11-22

    Meijer Recalls Vegetable Products Due to Listeria Contamination Risk

    Meijer Distribution is voluntarily recalling processed vegetable products, including Zucchini and Squash Combo, due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Vegetable products including: ZUCCHINI AND SQUASH COMBO
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0217-2018·2017-11-22

    CHI Greenhouse Recalls BrightFarms Baby Arugula Due to E. coli Risk

    CHI Greenhouse is voluntarily recalling BrightFarms Baby Arugula packages due to the potential presence of E. coli. The product was distributed in Illinois and Wisconsin.

    Product
    BrightFarms Baby Arugula (4 oz. package)
    Category
    Food
    Distribution
    2 states

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