The Recall Desk

Archive

December 2016 recalls

806 recalls were announced in December 2016.

What the numbers show

Critical
107
Severe
181
High
298
Moderate
178
Low
42

Of the 806 recalls this month scored against our rubric, 13% are Critical, 22% are Severe.

1–100 of 806

  • HighNHTSA·16V957000·2016-12-31

    Forest River Recalls 2017 Fifth-Wheel RVs Due to Door Hinge Defect

    Forest River is recalling 2017 XLR Toyhauler and Prime Time Spartan fifth-wheel vehicles because rear cargo door hinge welds may be insufficient, increasing the risk of personal injury.

    Product
    PRIME TIME — PRIME TIME, FOREST RIVER SPARTAN, XLR TOYHAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V946000·2016-12-30

    Porsche Recalls 2017 Models Due to Side Air Bag Defect

    Porsche is recalling 2017 911, 718 Cayman, and 718 Boxster vehicles because the side air bag inflator initiator may fail to ignite during a crash.

    Product
    PORSCHE — PORSCHE 911, 718 CAYMAN, 718 BOXSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V956000·2016-12-30

    Hyundai Recalls 2017 Sonata and Elantra for Air Bag Defect

    Hyundai is recalling 2017 Sonata and Elantra vehicles because the driver's air bag inflator seal may be improperly installed, potentially reducing protection in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA, ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16C009000·2016-12-30

    4moms Recalls Self-Installing Infant Car Seats Due to Attachment Defect

    4moms is recalling specific Self Installing Rear-facing Infant Car Seats because a tight rivet may prevent the carrier from securely attaching to the base, increasing injury risk in a crash.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V942000·2016-12-29

    Land Rover Recalls Vehicles for Defective Seatbelt Pretensioners

    Jaguar Land Rover is recalling 2016-2017 Range Rover, Range Rover Sport, and 2017 Discovery Sport vehicles because front seatbelt pretensioners may not function properly in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, RANGE ROVER, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V955000·2016-12-29

    Volkswagen and Audi Recall Vehicles for Air Bag and Seat Belt Defects

    Volkswagen Group of America is recalling specific 2016-2018 Audi and Volkswagen models because air bags or seat belt pretensioners may not function properly in a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI E-GOLF, A4 ALLROAD, GOLF, Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V945000·2016-12-29

    Ford Recalls 2017 F-250 and F-350 Trucks for Fuel Tank Strap Defect

    Ford is recalling 2017 F-250 and F-350 Super Duty trucks because a missing frame reinforcement bracket may allow the fuel tank strap to separate, increasing fire risk.

    Product
    FORD — FORD F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V944000·2016-12-29

    Glacier Recalls 2016 RV Explorers Due to Axle Bolt Defect

    Glacier is recalling 38 model year 2016 RV Explorer trailers because a short axle bolt may fail, causing the wheel assembly to detach and increasing crash risk.

    Product
    GLACIER — GLACIER RV EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V943000·2016-12-29

    Jaguar Recalls 2016-2017 XJ Models Due to Air Bag Defect

    Jaguar is recalling 2016-2017 XJ vehicles because the front passenger air bag may fail to deploy in a crash. Dealers will replace the air bag free of charge.

    Product
    JAGUAR — JAGUAR XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17061·2016-12-29

    Polaris Recalls Sportsman 570 ATVs Due to Fuel Leak Fire Hazard

    Polaris is recalling approximately 9,900 Sportsman 570 ATVs because the air intake duct can contact the fuel rail, causing a fuel leak and fire hazard.

    Product
    Sportsman 570 all-terrain vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V941000·2016-12-29

    Land Rover Recalls 2016-2017 Models for Air Bag Defect

    Jaguar Land Rover is recalling specific 2016 and 2017 Range Rover models because the front passenger air bag may fail to deploy in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT, RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0767-2017·2016-12-28

    Phil-Am Smoked Mackerel Recalled for Potential Botulism Contamination

    Phil-Am Trading is recalling smoked mackerel due to potential Clostridium botulinum contamination, which can cause life-threatening illness.

    Product
    Phil-Am Smoked Mackerel (Hasa Hasa) Net. Wt. 200g (7.05 oz.) packaged: Clear flexible plastic pouch and is topped by a predominantly red tag affixed to the top seal which has the products information.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0220-2017·2016-12-28

    FDA Recalls Black Label X Capsules for Undeclared Sildenafil

    Making It a Lifestyle is recalling 1,000 bottles of Black Label X capsules nationwide because they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0883-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling 4 GL pails of fruit mix with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0728-2017·2016-12-28

    Woodland Foods Recalls D'Allesandro Almond Trail Mix Due to Listeria Risk

    Woodland Foods is recalling D'Allesandro Almond Trail Mix because sunflower seeds in the product may be contaminated with Listeria.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO ALMOND TRAIL MIX". Product was packaged into 5 lb boxes.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-0228-2017·2016-12-28

    Sermorelin/GHRP-6 Injection Recalled for Non-Sterility and Microbial Contamination

    Town and Country Compounding and Consultation Services is recalling Sermorelin/GHRP-6 Injection due to non-sterility and Bacillus circulans contamination.

    Product
    Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0221-2017·2016-12-28

    FDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine

    The FDA is recalling Black Gold X Advanced capsules because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.

    Product
    BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0891-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Chunks Due to Listeria Risk

    Simply Fresh Fruit is recalling 50 pails of cantaloupe chunks because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0895-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling specific cantaloupe and fruit mix products because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO FRUIT MIX - LS, UPC 7486540223; 4 GL Pail UPC 7486572788
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0882-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Chunks Due to Listeria Risk

    Simply Fresh Fruit is recalling specific cantaloupe products because they may be contaminated with Listeria monocytogenes.

    Product
    4 GL PAIL SFF CANTALOUPE CHUNKS, UPC 4294710419; 4/1 GL Case Cantaloupe Chunks UPC 4294740119
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0620-2017·2016-12-28

    365 Brand Chocolate Croissants Recalled for Undeclared Eggs

    Whole Foods Market is recalling 365 Brand Chocolate Croissants 6-packs due to undeclared eggs. The product was sold in select stores in seven states and D.C.

    Product
    CROISSANT CHOCOLATE 6 PK
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0888-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes in grape juice because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL and 2x1 GL/case SFF FRUIT MIX IN GRAPE JUICE, UPC 4294717155
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0901-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Chunks for Listeria Risk

    Simply Fresh Fruit is recalling 276 pails of 1 GL CVF Cantaloupe Chunks because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0727-2017·2016-12-28

    Woodland Foods Recalls Sunflower Seeds for Listeria Contamination

    Woodland Foods is recalling D'Allesandro Roasted Salted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 26 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO ROASTED SALTED SUNFLOWER SEEDS ". Product was packaged into 5 lb boxes.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-0218-2017·2016-12-28

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 143,250 vials of Bupivacaine Hydrochloride Injection due to a confirmed report of particulate matter in a single vial.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0894-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Chunks Due to Listeria Risk

    Simply Fresh Fruit is recalling 30 pails of cantaloupe chunks because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0887-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes containing cantaloupe due to potential Listeria monocytogenes contamination.

    Product
    4/1 GL CANT/HONEYDEW/PINEAPPLE 3/4", UPC 4294740192
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0903-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0229-2017·2016-12-28

    Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria

    Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.

    Product
    COMFORT SHIELD BARRIER — COMFORT SHIELD BARRIER (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0879-2017·2016-12-28

    Simply Fresh Fruit Recalls Tropical Salad Due to Listeria Risk

    Simply Fresh Fruit is recalling 1-gallon pails of Tropical Salad because they may be contaminated with Listeria monocytogenes.

    Product
    1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0216-2017·2016-12-28

    Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination

    Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.

    Product
    Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0210-2017·2016-12-28

    Ultimate Body Tox PRO capsules recalled for undeclared sibutramine

    FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.

    Product
    Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0731-2017·2016-12-28

    Woodland Foods Recalls Smashburger Autumn Harvest Salad Topper Due to Listeria Risk

    Woodland Foods is recalling Smashburger Autumn Harvest Salad Topper because sunflower seeds used in the product may be contaminated with Listeria.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "smashburger Autumn Harvest Salad Topper".
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0730-2017·2016-12-28

    Woodland Foods Recalls Sunflower Seeds for Listeria Contamination

    Woodland Foods is recalling Di Bruno Bros Roasted & Salted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 25 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "DI BRUNO BROS ROASTED & SALTED SUNFLOWER E SEEDS".
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0896-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE, UPC 7486562450
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0885-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe Jars Due to Listeria Risk

    Simply Fresh Fruit is recalling 29 jars of cantaloupe chunks because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL JAR SFF CANTALOUPE CHUNKS - Light Syrup, UPC 4294700119
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0211-2017·2016-12-28

    Guardian Pharmacy Recalls Lidocaine Syringes Due to Failed Sterility Test

    Guardian Pharmacy Services is recalling 180 pre-filled Lidocaine HCL/Sodium Bicarb syringes because a sterility test failed. The product was distributed to two medical facilities in Texas.

    Product
    Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0223-2017·2016-12-28

    Skinny Bee Diet capsules recalled for undeclared dangerous ingredients

    Love My Tru Body is recalling Skinny Bee Diet capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0884-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    **1) 1 GL PAIL SFF FRUIT MIX, UPC #3522300553 and UPC4294710155; **2) 3 GL PAIL SFF FRUIT MIX, UPC #4294710355; **3) 4GL PAIL SFF FRUIT MIX UPC #4294710455; **4) 2/1 GL Case SFF Fruit Mix UPC 4294720155; **5) 4/1 GL case SFF Fruit Mix UPC #4294740155. ... **3) 4 GL PAIL
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2017·2016-12-28

    3rd Degree Capsules Recalled for Undeclared Sibutramine

    Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2017·2016-12-28

    Impax Recalls Lamotrigine Tablets Due to Labeling Mixup

    Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.

    Product
    Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2017·2016-12-28

    Amgen Recalls Kyprolis Vials Due to Potential Glass Cracks

    Amgen is recalling 11,434 vials of Kyprolis (carfilzomib) injection because potential cracks in the glass vials may compromise sterility.

    Product
    KYPROLIS — KYPROLIS (CARFILZOMIB)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0208-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/PGE1 injectable drug products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0782-2017·2016-12-28

    FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies

    The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.

    Product
    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Food)·F-0776-2017·2016-12-28

    Wakefern Recalls Dipped Chocolate Chip Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling Dipped Chocolate Chip Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    Dipped Chocolate Chip Cookies Net Wt. 24 oz UPC 269954004995
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0768-2017·2016-12-28

    Coliman Pacific Recalls Jalapeno Peppers Due to Salmonella Contamination Risk

    Coliman Pacific Corp is recalling jalapeno peppers because they may be contaminated with Salmonella. The affected product was distributed in California and Arizona.

    Product
    Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0214-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures

    Virtus Pharmaceuticals is recalling 24,444 bottles of Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in inconsistent drug potency.

    Product
    Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0832-2017·2016-12-28

    Samuel Adams Apple Hard Cider Recalled for Bottle Bursting Risk

    Samuel Adams Brewery is recalling Apple Orchard Crisp Apple Hard Cider because bottles may burst due to re-fermentation.

    Product
    Apple Orchard Crisp Apple Hard Cider Three packages sizes: ¿ Loose case = 24  12 oz bottles ¿ 12 pack = 12  12 oz bottles, shipped as 2  12 packs per case ¿ 4  6 pack = 6  12 oz bottles per pack, shipped as 4  6 packs per case
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0777-2017·2016-12-28

    Wakefern Recalls Chocolate Dipped Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling Gourmet Chocolate Dipped Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0227-2017·2016-12-28

    Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns

    Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.

    Product
    Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0217-2017·2016-12-28

    Novo Nordisk Recalls GlucaGen HypoKits Due to Detached Needles

    Novo Nordisk is recalling 71,215 GlucaGen HypoKits because the syringe needles may be detached. The recall covers lots expiring in September 2017.

    Product
    GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0866-2017·2016-12-28

    Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk

    Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.

    Product
    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used fo
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0206-2017·2016-12-28

    Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 30,910 bags of Fluconazole Injection due to confirmed customer complaints of leaking bags, which compromises sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0729-2017·2016-12-28

    Woodland Foods Salt-Free Roasted Sunflower Seeds Recalled for Listeria

    Woodland Foods is recalling salt-free roasted sunflower seeds potentially contaminated with Listeria. The product was distributed to food distributors in 25 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "N34D SALT-FREE ROASTED SUNFLOWER SEEDS".
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-0942-2017·2016-12-28

    Interbake Foods Recalls Girl Scout Peanut Butter Sandwiches Due to Aflatoxin

    Interbake Foods is recalling Girl Scout Peanut Butter Sandwiches because a single lot of peanut butter used contained elevated aflatoxin levels.

    Product
    Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0775-2017·2016-12-28

    Wakefern Recalls Kid's Rainbow Sprinkled Cookie Platter Due to Metal Pieces

    Wakefern Food Corp. is recalling Kid's Rainbow Sprinkled Cookie Platters because they may contain metal pieces. The product was distributed in six states.

    Product
    Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0773-2017·2016-12-28

    Wakefern Recalls 24-Pack Red Velvet Cookies for Metal Pieces

    Wakefern Food Corp. is recalling 24-pack Gourmet Red Velvet Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24 pack Gourmet Red Velvet Cookies Net WT. 30 oz. UPC 28977400000
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0878-2017·2016-12-28

    Merge OrthoCase software recall due to measurement errors

    Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.

    Product
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-0887-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

    Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0762-2017·2016-12-28

    Naturecom Recalls DMAA Powder Due to Potential Presence of 1,3-Dimethylamylamine

    Naturecom is recalling 500g bags of DMAA powder because the product may contain 1,3-dimethylamylamine. The recall covers products distributed nationwide and internationally.

    Product
    DMAA (1,3-Dimethylamylamine) Net Weight 500g Product is packaged in approximately 8" x 11 silver and clear mylar ziplock bags that contain 500g of DMAA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.

    Product
    Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0785-2017·2016-12-28

    Wakefern Recalls 24-Count Candy Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-Count Candy Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Candy Cookies Net Wt. 24oz UPC 208713004197
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0726-2017·2016-12-28

    Woodland Foods Recalls Salt-Free Roasted Sunflower Seeds for Listeria Risk

    Woodland Foods is recalling D'Allesandro Salt-Free Roasted Sunflower Seeds due to potential Listeria contamination. The product was distributed to food distributors in 26 states.

    Product
    Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO SALT-FREE ROASTED SUNFLOWER SEEDS". Product was packaged into 5 & 40 lb boxes.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-0784-2017·2016-12-28

    Wakefern Sugar Cookies Recalled for Potential Metal Contamination

    Wakefern Food Corp. is recalling 24-count sugar cookies due to the potential presence of metal pieces. The product was distributed in six states.

    Product
    24CT Sugar Cookies Net Wt. 24oz UPC 208719004191
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0900-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes for Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 50758108455745
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0746-2017·2016-12-28

    Midwest International Recalls Low Acid Canned Fish Without Registered Process

    Midwest International Corp is recalling low acid canned fish products that lack a registered manufacturer and scheduled process. The recall covers distribution in eight states.

    Product
    Qiejidingxiangyu, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0209-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/ATROP/PGE1 injectable products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0902-2017·2016-12-28

    Simply Fresh Fruit Recalls Cantaloupe and Fruit Mixes Due to Listeria Risk

    Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

    Product
    **1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810 8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904; **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **5) 1 GL CVF FRUIT SALAD DELUXE
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0780-2017·2016-12-28

    Wakefern Recalls Take&Bake Sugar Cookies Due to Metal Pieces

    Wakefern Food Corp. is recalling 24-count Take&Bake Sugar Cookies because they may contain metal pieces. The product was distributed in six states.

    Product
    24CT Take&Bake Sugar Cookies Net Wt. 24oz UPC 208906004195
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0889-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.

    Product
    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0213-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2017·2016-12-28

    US Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination

    US Compounding Inc is recalling 10,665 Docusate Oral 10 mg/mL syringes distributed in Texas due to microbial contamination with B. cepacia.

    Product
    Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0766-2017·2016-12-28

    Chaos and Pain Recalls Cannibal Ferox Amped Pre-Workout Supplement

    Chaos and Pain is recalling its Cannibal Ferox Amped pre-workout supplement because it contains an undeclared prohibited substance.

    Product
    CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0810-2017·2016-12-28

    Oscor Breezeway Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.

    Product
    OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0818-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled Due to Liner Fragmentation

    Oscor, Inc. is recalling 55 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0885-2017·2016-12-28

    Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0815-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragment Release

    Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0791-2017·2016-12-28

    Oscor Medical Sheath Recalled for Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 87 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0797-2017·2016-12-28

    Crescent Vending Recalls Roast Beef and Cheddar Sandwiches for Undeclared Allergens

    Crescent Vending Co. Inc. is recalling 11 roast beef and cheddar cheese sandwiches on Kaiser rolls due to undeclared wheat, soy, and milk allergens.

    Product
    Roast Beef and Cheddar Cheese on Kaiser Roll wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0898-2017·2016-12-28

    Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization

    Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.

    Product
    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomiz
    Category
    Medical Device
    Distribution
    Distributed nationwide

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