The Recall Desk

Archive

January 2018 recalls

494 recalls were announced in January 2018.

What the numbers show

Critical
39
Severe
121
High
177
Moderate
138
Low
19

Of the 494 recalls this month scored against our rubric, 8% are Critical, 24% are Severe.

1–100 of 494

  • CriticalFDA (Food)·F-0608-2018·2018-01-31

    Fresh Pak Recalls Aunt Mid's Michigan Apples Due to Listeria Risk

    Fresh Pak, Inc. is recalling Aunt Mid's Michigan Apples slice bags due to potential Listeria monocytogenes contamination. The product was distributed in Michigan, Ohio, and Wisconsin.

    Product
    5/2.2oz Slice Apple Bags in clamshell - Aunt Mid s Michigan Apples brand. 6 units per case
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0470-2018·2018-01-31

    Hard Times For Men capsules recalled for undeclared sildenafil

    The FDA is recalling Hard Times For Men capsules because they contain undeclared sildenafil and were marketed without an approved NDA or ANDA.

    Product
    Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0471-2018·2018-01-31

    BotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine

    BotanicalNow is recalling BodySlim Herbal capsules because FDA analysis found undeclared sibutramine, a substance not approved for use in this product.

    Product
    BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0609-2018·2018-01-31

    Fresh Pak Recalls Aunt Mid's Sliced Apples and Grapes for Listeria

    Fresh Pak, Inc. is recalling Aunt Mid's brand sliced apples and grapes bags due to potential Listeria monocytogenes contamination. The product was distributed in Michigan, Ohio, and Wisconsin.

    Product
    5/2.5oz Slice Apples w/ grapes bags in clamshell - Aunt Mid s brand. 6 units per case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0627-2018·2018-01-31

    Pharmatech Recalls Leader Liquid Vitamin D Supplement for Infants

    Pharmatech LLC is recalling Leader Liquid Vitamin D Supplement for Breastfed Infants due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Leader Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL UPC 096295128628
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0575-2018·2018-01-31

    Advanced Pharma Recalls Subpotent Magnesium Sulfate IV Bags

    Advanced Pharma Inc. is recalling 25 bags of Magnesium Sulfate IV solution in Texas due to subpotent product.

    Product
    MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0610-2018·2018-01-31

    Fresh-Pak 9oz Slice Apples Recalled for Listeria Contamination

    Fresh Pak, Inc. is recalling 9oz Slice Apples containers potentially contaminated with Listeria monocytogenes. The product was distributed in Michigan, Ohio, and Wisconsin.

    Product
    9oz Slice Apples Container - Fresh-Pak brand. 1 unit per case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0611-2018·2018-01-31

    Fresh-Pak Sliced Apples Recalled for Listeria Contamination

    Fresh Pak, Inc. is recalling 9oz containers of sliced apples potentially contaminated with Listeria monocytogenes.

    Product
    9oz Mix (red/green) Slice Apples Container - Fresh-Pak brand. 1 unit per case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0635-2018·2018-01-31

    Pharmatech Recalls Leader Liquid Multivitamin for Yeast Contamination

    Pharmatech LLC is recalling Leader Liquid Multivitamin Supplement for Infants and Toddlers due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Leader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL UPC 096295128611
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0233-2018·2018-01-31

    Pravastatin Sodium Tablets Recalled Due to Foreign Tablet Presence

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets 10 mg because bottles may contain 20 mg tablets.

    Product
    Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0612-2018·2018-01-31

    Fresh Pak Fruit and Cheese Snacks Recalled for Listeria Risk

    Fresh Pak, Inc. is recalling 7oz fruit and cheese snacks potentially contaminated with Listeria monocytogenes. The products were distributed in Michigan, Ohio, and Wisconsin.

    Product
    7oz Fruit and cheese Snacks - no brand. 1 unit per case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0634-2018·2018-01-31

    Rugby Poly-Vitamin w/ Iron Liquid Recalled for Yeast and B. cepacia

    Pharmatech LLC is recalling Rugby Poly-Vitamin w/ Iron Liquid 50 mL due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Rugby Poly-Vitamin w/ Iron Liquid 50 mL UPC 00536-8530-80
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0234-2018·2018-01-31

    International Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets

    International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, 20 mg, because bottles may contain 10 mg tablets. Patients should contact their healthcare provider.

    Product
    Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0620-2018·2018-01-31

    Rugby Liquid Vitamin C Supplement Recalled for Yeast and B. cepacia

    Pharmatech LLC is recalling Rugby Liquid Vitamin C Supplement 500 mg due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0626-2018·2018-01-31

    Rugby D3 Vitamin Liquid Recalled for Yeast and B. cepacia Contamination

    Pharmatech LLC is recalling Rugby D3 Vitamin liquid due to the presence of yeast and potential contamination with B. cepacia.

    Product
    Rugby D3 Vitamin liquid 400 IU/1 mL dose 1 2/3 fl. oz. (50 mL) UPC 00536-8400-80
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0606-2018·2018-01-31

    Nestle HOT POCKETS Four Cheese Pizza Snack Bites Recalled for Missing Labeling

    Nestle USA is recalling 4,200 lbs of HOT POCKETS Four Cheese Pizza Snack Bites because the product was distributed without an ingredient statement or labeling, despite containing various allergens.

    Product
    Nestle HOT POCKETS¿ FOUR CHEESE PIZZA SNACK BITES in clear plastic bags.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0401-2018·2018-01-31

    Sorin CP5 Centrifugal Pump Recalled for Delayed Air Bubble Detection Response

    Sorin Group is recalling CP5 Centrifugal Pumps because the automatic line closure after air bubble detection may take longer than intended.

    Product
    CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·18718·2018-01-31

    John Deere Recalls Compact Utility Tractors Due to Brake Failure

    John Deere is recalling about 600 model 2025R compact utility tractors because the brakes can fail, posing crash and injury hazards.

    Product
    John Deere Compact Utility Tractors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2018·2018-01-31

    Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk

    Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.

    Product
    Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0683-2018·2018-01-31

    Condies Foods Recalls Fresh Fruit for Undeclared Milk and Egg

    Condies Foods is recalling Fresh Fruit (Item 40781) due to undeclared milk and egg allergens. The product was distributed to Coremark stores in seven western states.

    Product
    Condies Foods Fresh Fruit, Item Number 40781, UPC 50777222655
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0405-2018·2018-01-31

    Siemens Syngo Imaging PACS Recalled for Potential Data Loss

    Siemens is recalling 36 units of Syngo Imaging version V31 software due to a potential risk of data loss relevant to diagnosis.

    Product
    Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0602-2018·2018-01-31

    Aveka Nutra Processing Recalls Deactivated Dry Yeast Due to Metal Contamination

    Aveka Nutra Processing is recalling specific lots of SAF PRO RELAX +YF deactivated dry yeast because the product may contain pieces of metal.

    Product
    SAF PRO RELAX +YF, Deactivated Dry Yeast, Product Code 73050, Net Wt. 50 LBS. (22.7 KG), manufactured for Lesaffre Yeast Company, Milwaukee, WI.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0344-2018·2018-01-31

    Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk

    Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.

    Product
    Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0607-2018·2018-01-31

    Fresh Pak Recalls 3lb Bags of Diced Red Apples for Listeria Risk

    Fresh Pak, Inc. is recalling 3lb bags of diced red apples potentially contaminated with Listeria monocytogenes. The product was distributed in Michigan, Ohio, and Wisconsin.

    Product
    3lb Bag Dice Red Apples - no brand. 4 units per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0345-2018·2018-01-31

    Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk

    Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow into patient airways.

    Product
    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2018·2018-01-31

    Baxter Recalls MARS Treatment Kits Due to Albumin Circuit Leakage

    Baxter Healthcare is recalling 186 MARS Treatment Kits because of a defect in the albumin circuit that causes leakage. The issue stems from an inadequate adhesive connection in the tubing.

    Product
    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0407-2018·2018-01-31

    Inovo CHAD Drive Oxygen Concentrators Recalled for Low Purity

    Inovo, Inc. is recalling CHAD Drive oxygen concentrators because post-market surveillance found a high rate of low oxygen purity complaints.

    Product
    PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0410-2018·2018-01-31

    Somatex TUMARK Q Medical Device Recalled for Sterility Risk

    Somatex Medical Technologies is recalling TUMARK Q devices due to a potential risk of packaging puncture that could compromise sterility.

    Product
    TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0403-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2018·2018-01-31

    Smith & Nephew Taylor Spatial Frame Software Recalled for Image Inversion

    Smith & Nephew is recalling Taylor Spatial Frame software versions 5.2.5 and 5.2.6 because the software may generate inverted images of the frame during strut adjustment planning.

    Product
    Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengtheni
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0399-2018·2018-01-31

    Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.

    Product
    MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0400-2018·2018-01-31

    Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.

    Product
    MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0343-2018·2018-01-31

    Vyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk

    Vyaire Medical is recalling 16,670 Infant AirLife single-limb circuits and humidification chambers because a manufacturing error may cause water to back up into the patient's airway.

    Product
    Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0241-2018·2018-01-31

    DLC Laboratories Recalls Earth's Care Eczema Lotion Due to Microbial Contamination

    DLC Laboratories is recalling Earth's Care Eczema Lotion due to microbial contamination. The product was distributed nationwide.

    Product
    Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0643-2018·2018-01-31

    Grand Central Bakery Recalls Potato Buns for Milk Allergen Mislabeling

    Grand Central Bakery Inc. is recalling 92 bags of Potato Buns because the label fails to declare milk in the 'Contains' statement, despite listing it in ingredients.

    Product
    Potato Buns, 4 pieces packaged in poly bag, net wt.11.8 oz. The label is read in parts: "***POTATO BUNS***NET WT. 11.8 OZ***Ingredients:***Enriched unbleached wheat flour***buttermilk powder, butter ***Contains: wheat, dairy***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0402-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2018·2018-01-31

    Smith & Nephew Mini-Fragment Plating System Recalled for Labeling Error

    Smith & Nephew is recalling two units of bone plates due to incorrect labeling of the plate type.

    Product
    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fr
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0393-2018·2018-01-31

    BD MAX UVE Specimen Collection Kit Recalled for Test Result Issues

    Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-testing.

    Product
    BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0239-2018·2018-01-31

    Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling specific lots of 600 mg ibuprofen tablets due to odor complaints linked to CGMP deficiencies.

    Product
    Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2018·2018-01-31

    Smith & Nephew Recalls Mislabeled Mini-Fragment Bone Plating System Devices

    Smith & Nephew is recalling two units of bone plates and screws that were incorrectly labeled as one model but contained a different model.

    Product
    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mi
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0238-2018·2018-01-31

    Marksans Pharma Recalls Ibuprofen Tablets Due to Odor Complaints

    Marksans Pharma Inc. is recalling 21,584,100 Ibuprofen Tablets, USP 400 mg, due to odor complaints linked to CGMP deficiencies.

    Product
    Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2018·2018-01-31

    Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments

    Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.

    Product
    daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0240-2018·2018-01-31

    Ibuprofen Tablets Recalled for Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling 52,549,000 ibuprofen tablets due to odor complaints and CGMP deficiencies. The product was distributed nationwide.

    Product
    Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2018·2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results

    Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0642-2018·2018-01-31

    Grand Central Bakery Recalls Hot Dog Buns for Labeling Error

    Grand Central Bakery Inc. is recalling 90 bags of hot dog buns in Washington because the label failed to list milk in the 'Contains' statement.

    Product
    Hot Dog Buns, 6 pieces packaged in a poly bag, net wt 17.3 oz. The label is read in parts: "***HOTDOG BUNS***NET WT. 17.3 OZ***Ingredients:***Enriched unbleached wheat flour***egg, whole milk (milk, vitamin A, vitamin D3), butter***Contains: wheat, egg, dairy***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0641-2018·2018-01-31

    Blommer Chocolate Recalls ERNIES Candy Due to Potential Foreign Material

    Blommer Chocolate Company is recalling 20,000 lbs of ERNIES chocolate candy because missing pieces from light shields may have contaminated the product.

    Product
    Blommer Chocolate Company ERNIES (chocolate candy centers with candy shell) Net Wt. 25 lbs. Ingredients: Sugar, cocoa, hydrogenated palm kernel oil, whey, artificial color (FD&C Blue No. 1, Blue No 1 Lake, Blue #2 Lake, Yellow #5, Yellow No. 5 Lake, Yellow No. 6, Yellow No.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0236-2018·2018-01-31

    Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling 4,127,500 ibuprofen tablets due to odor complaints and CGMP deficiencies. The product was distributed nationwide to repackaging firms.

    Product
    Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2018·2018-01-31

    Ibuprofen Tablets Recalled for Odor Complaints and CGMP Deficiencies

    Marksans Pharma Inc. is recalling ibuprofen tablets due to odor complaints linked to Current Good Manufacturing Practice (CGMP) deficiencies.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2018·2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Results

    Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0406-2018·2018-01-31

    Smith & Nephew Recalls Radial Osteotome Blades Due to Incorrect Expiration Dates

    Smith & Nephew is recalling nine Radial Osteotome Blades because the expiration dates on the labels are incorrect. The devices were distributed in the US and Australia.

    Product
    Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0395-2018·2018-01-31

    Measurement Specialties Reusable Temperature Probes Recalled for Unvalidated Sterilization Instructions

    Measurement Specialties Inc. is recalling 6,076 reusable temperature probes because their sterilization instructions have not been proven through a validation study.

    Product
    Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0232-2018·2018-01-31

    Odan Laboratories Recalls Dry to Normal Skin Starter Kit for Stability Failure

    Odan Laboratories is recalling 179 kits of Dry to Normal Skin Starter Kit because the product failed stability specifications at 12 months.

    Product
    Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0231-2018·2018-01-31

    Odan Laboratories Recalls Day Cream SPF15 Due to Stability Failure

    Odan Laboratories is recalling 21 jars of Day Cream SPF15 because the product failed stability specifications at 12 months.

    Product
    Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0408-2018·2018-01-31

    Smith & Nephew Recalls EVOS Flex Plates Due to Packaging Error

    Smith & Nephew is recalling 12 units of EVOS 2.4MM Flex Plates because the packaging contained templates. The recall covers distribution to Oregon and Colombia.

    Product
    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0398-2018·2018-01-31

    Anspach Effort Recalls Oscillating Saw Attachment Due to Shipping Error

    The Anspach Effort, Inc. is voluntarily recalling one oscillating saw attachment because it was mistakenly shipped to a non-veterinary customer.

    Product
    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0230-2018·2018-01-31

    Mylan Recalls Bupropion HCL Extended-Release Tablets Due to Impurities

    Mylan Pharmaceuticals is voluntarily recalling specific bottles of bupropion HCL extended-release tablets due to out-of-specification impurities found during routine stability testing.

    Product
    bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E007000·2018-01-30

    Lippert Components Recalls Ford F53 Chassis for Driveshaft Misalignment

    Lippert Components is recalling specific Ford F53 chassis used in Coachmen and Mirada RVs because a misaligned driveshaft may cause excessive vibration and potential vehicle disablement.

    Product
    STRUCTURE:FRAME AND MEMBERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V080000·2018-01-30

    Forest River Recalls 2018 Georgetown RVs Due to Wiring Fire Risk

    Forest River is recalling 2018 Georgetown recreational vehicles because undersized wiring may melt and cause a fire. Dealers will install an additional circuit breaker free of charge.

    Product
    FOREST RIVER — FOREST RIVER GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V077000·2018-01-30

    Entegra Recalls Aspire and Insignia Motorhomes Due to Brake Reservoir Defect

    Entegra is recalling 2015-2018 Aspire and Insignia motorhomes because the air brake supply reservoir is undersized, which may reduce braking performance and increase crash risk.

    Product
    ENTEGRA — ENTEGRA INSIGNIA, ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V082000·2018-01-30

    Audi Recalls Vehicles Due to Driver Air Bag Inflator Explosion Risk

    Volkswagen Group of America is recalling specific Audi models because the driver's air bag inflator may explode during deployment, potentially causing serious injury or death.

    Product
    AUDI — AUDI S5 CABRIOLET, S4 CABRIOLET, A3, A4 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V079000·2018-01-30

    Eclipse Recalls 2019 Attitude Trailers Due to Incorrect Tire Load Range

    Eclipse Recreational Vehicles is recalling 2019 Attitude trailers equipped with tires that have the incorrect load range, which may lead to tire failure and increase crash risk.

    Product
    ECLIPSE — ECLIPSE ATTITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V078000·2018-01-30

    Jayco Recalls 2017 Precept Motorhomes Due to Brake Fluid Leak Risk

    Jayco is recalling 2017 Precept motorhomes because missing valve block ball plugs in the brake system may cause fluid leaks or air ingestion, increasing stopping distance.

    Product
    JAYCO — JAYCO PRECEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18086·2018-01-30

    Walgreens Pain and Itch Relief Cream Recalled for Packaging Safety

    Natureplex is recalling Well at Walgreens pain and itch relief cream because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    Well at Walgreens pain and itch relief cream
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V083000·2018-01-30

    Thomas Built Buses Recall Fire Extinguishers Due to Clogging and Injury Risk

    Daimler Trucks North America is recalling 2002-2017 Thomas Built Buses equipped with specific Kidde fire extinguishers that may clog or detach, posing injury risks.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, FS-65, SAF-T-LINER C2, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V072000·2018-01-29

    Jayco Eagle Travel Trailer Recall for Underrated Safety Chains

    Jayco is recalling 2017-2018 Eagle 333BHOK travel trailers because the safety chains are rated below the vehicle's weight limit, posing a crash risk if the trailer detaches.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V076000·2018-01-29

    Harley-Davidson Recalls ABS Motorcycles Due to Brake Fluid Deposits

    Harley-Davidson is recalling 2008-2011 ABS-equipped motorcycles because brake fluid deposits may cause the ABS valve to stick, reducing braking ability and increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON VRSCF, VRSCDXA, VRSCDX, VRSCDA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V075000·2018-01-29

    Jayco Recalls 2018 Eagle Travel Trailers Due to Stove Gas Leak Risk

    Jayco is recalling 2018 Eagle travel trailers because the furnace can cause the cooktop flame to go out while gas continues to flow, creating an explosion risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V073000·2018-01-29

    Jayco Recalls 2018 Eagle Travel Trailers for Incorrect Weight Labeling

    Jayco is recalling 2018 Eagle travel trailers because the Gross Vehicle Weight Rating label may be incorrect, potentially allowing the vehicle to be overloaded.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18T001000·2018-01-29

    Vogue Tyre & Rubber Recalls Signature V Tires for Missing Date Codes

    Vogue Tyre & Rubber is recalling specific Signature V tires because they lack date codes on the sidewall, which may prevent owners from identifying recalled tires.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V071000·2018-01-26

    Mitsubishi Recalls Vehicles Due to Sunroof Glass Detachment Risk

    Mitsubishi is recalling specific 2007-2010 models because the sunroof glass may detach and become a road hazard, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER SPORTBACK, LANCER EVOLUTION, LANCER, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V069000·2018-01-26

    Mitsubishi Recalls Vehicles Due to Drive Belt Tensioner Flange Crack Risk

    Mitsubishi is recalling specific 2008-2012 models because a cracked drive belt tensioner flange may cause the belt to detach, leading to engine stalling and increased crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, LANCER, OUTLANDER SPORT, LANCER SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V070000·2018-01-26

    Mitsubishi Recalls Outlander Models for Parking Brake Corrosion Risk

    Mitsubishi is recalling 2013-2016 Outlander and Outlander Sport vehicles because water may cause parking brake parts to corrode and bind, potentially preventing the brake from engaging.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V068000·2018-01-25

    Honda Recalls 2017 Clarity Fuel Cell Vehicles for Power Loss Risk

    Honda is recalling 2017 Clarity Fuel Cell vehicles because a software defect may cause reduced or complete power loss, increasing crash risk.

    Product
    HONDA — HONDA CLARITY FUEL CELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18085·2018-01-25

    Elkay Recalls Water Coolers and Bottle Filling Stations Due to Shock Hazard

    Elkay is recalling water coolers and bottle filling stations because internal screws can break, causing a loose grounding wire and shock hazard.

    Product
    Elkay and Halsey Taylor water coolers and bottle filling stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18083·2018-01-25

    VTech Recalls Infant Elephant Rattles Due to Choking Hazard

    VTech is recalling Shake & Sing Elephant Rattles because the ears can break off, posing a choking hazard to young children.

    Product
    Shake & Sing Elephant Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0686-2018·2018-01-24

    Fieldbrook Foods Recalls Sundae Shoppe Raspberry Cream Ice Cream Bars

    Fieldbrook Foods is recalling Sundae Shoppe Raspberry Cream Ice Cream Bars due to potential Listeria monocytogenes contamination. The product was distributed nationwide, including Puerto Rico.

    Product
    RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC 041498204631
    Category
    Food
    Distribution
    Distributed nationwide

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