The Recall Desk

Archive

September 2017 recalls

342 recalls were announced in September 2017.

What the numbers show

Critical
24
Severe
115
High
101
Moderate
92
Low
10

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

101–200 of 342

  • SevereNHTSA·17V597000·2017-09-25

    Keystone Recalls 2008-2009 Raptor RVs Due to Fire Risk

    Keystone RV Company is recalling 2008-2009 Raptor recreational vehicles because a faulty transfer switch may fail under high heat and load, increasing the risk of fire.

    Product
    KEYSTONE — KEYSTONE RAPTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17232·2017-09-25

    Pro-Tec Recalls Multisport Helmets Due to Buckle Safety Failure

    Pro-Tec is recalling City Lite and Street Lite multisport helmets because the chin strap buckles fail to meet federal safety standards, posing a risk of head injury.

    Product
    Multisport helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17231·2017-09-25

    Delta Recalls J is for Jeep Strollers Due to Fall Hazard

    Delta is recalling about 28,000 J is for Jeep jogging strollers because the leg bracket can break, posing a fall hazard to infants.

    Product
    J is for Jeep brand cross-country all-terrain jogging strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V599000·2017-09-25

    Ford Recalls 2017 F-Series Trucks Due to Seat Belt Anchor Weld Defect

    Ford is recalling 2017 F-150, F-250, F-350, F-450, and F-550 trucks because the front passenger seat belt anchor may not be adequately welded, increasing injury risk in a crash.

    Product
    FORD — FORD F-350 SD, F-150, F-550 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V593000·2017-09-22

    PACCAR Recalls 2016 Peterbilt and Kenworth Trucks for Steering Defect

    PACCAR is recalling 2016 Peterbilt and Kenworth trucks because a steering component may loosen, potentially causing a complete loss of steering and increasing crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T660, 567, 220, 320
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V592000·2017-09-22

    Mercedes-Benz Recalls 2016 Sprinter Vans for Driveshaft Fire Risk

    Daimler Vans USA is recalling 2016 Mercedes-Benz Sprinter 2500 and 3500 vehicles because a missing driveshaft catch strap could allow the driveshaft to strike the fuel tank, creating a fire risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V595000·2017-09-22

    Mercedes-Benz Recalls Metris Vans Due to Steering Defect

    Daimler Vans USA is recalling 2015-2017 Mercedes-Benz Metris vans because improperly welded steering pins may cause power assist to fail, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V587000·2017-09-21

    Thomas Built Buses Recalling School Buses for Missing Seat Brackets

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses Saf-T-Liner HDX and C2 school buses because a reinforcement bracket may be missing from seats with 3-point seat belts.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V585000·2017-09-21

    Forest River Recalls 2017-2018 Glaval Transit Buses Due to Seat Washer Defect

    Forest River is recalling 2017-2018 Glaval transit buses because seat mounting washers may crack and dislodge, increasing injury risk during sudden stops or crashes.

    Product
    GLAVAL BUS — GLAVAL BUS, GLAVAL APOLLO, COMMUTE, TITAN II LOW FLOOR, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V588000·2017-09-21

    Daimler Recalls Western Star 4700 Trucks for Battery Cable Fire Risk

    Daimler Trucks North America is recalling 2013-2018 Western Star 4700 trucks because a battery cable may contact the axle yoke, posing a fire risk.

    Product
    WESTERN STAR — WESTERN STAR 4700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V589000·2017-09-21

    Thomas Built Buses Recall Saf-T-Liner Models for Missing Seat Brackets

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses Saf-T-Liner HDX and C2 models because a missing reinforcement bracket may compromise seat security during a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17230·2017-09-21

    Renthal Recalls Gen 1 and Gen 2 Motorcycle Clip-on Handlebars

    Renthal is recalling Gen 1 and Gen 2 motorcycle clip-on handlebars because the clamp can crack and fail, posing a crash hazard. No injuries have been reported.

    Product
    Gen1 and Gen 2 motorcycle clip-on handlebars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1145-2017·2017-09-20

    Super Panther 7K Capsules Recalled for Unapproved Ingredients

    Chiavna Saffron LLC is recalling Super Panther 7K Capsules because FDA analysis found the product was tainted with sildendafil and tadalafil and marketed without an approved NDA/ANDA.

    Product
    Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1144-2017·2017-09-20

    FDA Recalls New Kopi Jantan Coffee for Undeclared Ingredients

    Bestherbs Coffee LLC is recalling New Kopi Jantan coffee packets because they contain undeclared desmethyl carbodenafil and milk.

    Product
    New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3524-2017·2017-09-20

    Major CertaVite Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major CertaVite Liquid due to possible B. cepacia contamination, which poses a risk of serious infection to patients with compromised immune systems or chronic lung conditions.

    Product
    Major CertaVite Liquid, 8 oz. (236 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1143-2017·2017-09-20

    Andropharm M1 Alpha capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 1,250 bottles of M1 Alpha capsules sold in Florida because the product was marketed without an approved NDA or ANDA.

    Product
    ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1142-2017·2017-09-20

    Andropharm Sten Z capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 150 bottles of Andropharm Sten Z capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·17V579000·2017-09-20

    Navistar Recalls 2018-2019 IC Bus CE School Buses for Brake Hose Routing

    Navistar is recalling 2018-2019 IC Bus CE school buses because the hydraulic brake hose may contact the tire, potentially causing fluid leaks and reduced braking performance.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V575000·2017-09-20

    2016 International Commercial Vehicles Recalled for Steering Tie Rod Defect

    Navistar is recalling 2016 International and IC Bus vehicles because a steering axle nut may not be properly torqued, risking loss of steering.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS DURASTAR, LONESTAR, PROSTAR, WORKSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3526-2017·2017-09-20

    Voluntary Recall of Major Ferrous Drops Due to B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Ferrous Drops due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Major Ferrous Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3527-2017·2017-09-20

    Major Poly-Vita Drops Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops due to possible B. cepacia contamination, which poses a serious infection risk to immunocompromised patients.

    Product
    Major Poly-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3521-2017·2017-09-20

    Rugby Polyvitamin Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Polyvitamin Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1148-2017·2017-09-20

    Bella Pharmaceuticals Recalls Mannitol 20% Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Mannitol 20% 10 mL vials because the company cannot ensure the product is sterile.

    Product
    Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2017·2017-09-20

    Bella Pharmaceuticals Recalls B-Complex Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.

    Product
    B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2017·2017-09-20

    Bella Pharmaceuticals Recalls Fluorescein Sodium Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 644 vials of Fluorescein Sodium due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1154-2017·2017-09-20

    Bella Pharmaceuticals Recalls L-Glutamine Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of L-Glutamine 100mg vials because the company cannot guarantee the product is sterile.

    Product
    L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3522-2017·2017-09-20

    Rugby Polyvitamin Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Polyvitamin Liquid with Iron due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3520-2017·2017-09-20

    Rugby Ferrous Sulfate Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Ferrous Sulfate Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3519-2017·2017-09-20

    Rugby Liquid Vitamin C Supplement Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Liquid Vitamin C Supplement due to possible contamination with B. cepacia, which may cause serious infections.

    Product
    Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3529-2017·2017-09-20

    Major Tri-Vita Drops Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Tri-Vita Drops due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Major Tri-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3528-2017·2017-09-20

    Voluntary Recall of Major Poly-Vita Drops Due to B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major Poly-Vita Drops with Iron due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2017·2017-09-20

    Bella Pharmaceuticals Recalls PF-Glutathione Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 82 vials of PF-Glutathione 200mg/ml because the product lacks assurance of sterility.

    Product
    PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2017·2017-09-20

    Bella Pharmaceuticals Recalls Lidocaine Ophthalmic Gel Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Lidocaine Ophthalmic Gel 3.5% because the product lacks assurance of sterility.

    Product
    Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3516-2017·2017-09-20

    Rugby Cerovite Liquid Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Cerovite Liquid due to possible B. cepacia contamination, which may cause serious infections in vulnerable patients.

    Product
    Rugby Cerovite Liquid, 8 oz. 236ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1153-2017·2017-09-20

    Bella Pharmaceuticals Recalls Magnesium Chloride Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Magnesium Chloride 200mg vials because the company cannot ensure the product is sterile.

    Product
    Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V576000·2017-09-20

    Porsche Recalls Cayenne Models Due to Fuel Pump Flange Crack Risk

    Porsche is recalling specific 2003-2006 Cayenne models because a fuel pump flange may crack, allowing fuel to leak and increasing fire risk.

    Product
    PORSCHE — PORSCHE CAYENNE S, CAYENNE TURBO, CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V577000·2017-09-20

    Hyundai Recalls 2018 Santa Fe Sport Vehicles for Front Coil Spring Defect

    Hyundai is recalling 2018 Santa Fe Sport vehicles because improperly manufactured front coil springs may fracture, potentially puncturing tires and causing loss of control.

    Product
    HYUNDAI — HYUNDAI SANTA FE SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V580000·2017-09-20

    Navistar Recalls 2016 IC Bus CE School Buses for Steering Defect

    Navistar is recalling 2016 IC Bus CE school buses because a steering component may loosen, potentially causing a loss of steering and increasing crash risk.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V581000·2017-09-20

    Rosenbauer Commander Recall: Diesel Fuel Pump Gear May Slip

    Rosenbauer is recalling one 2017 Commander emergency vehicle because a fuel pump gear may slip, causing sudden engine stall and crash risk.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1141-2017·2017-09-20

    Centurion Labs Recalls Ninjacof-A Oral Solution Due to Microbial Contamination

    Centurion Labs is recalling Ninjacof-A oral solution due to potential B. cepacia contamination. Consumers should stop using the product and return it to the pharmacy.

    Product
    Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-033-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3518-2017·2017-09-20

    Rugby Fer-iron Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Fer-iron Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3530-2017·2017-09-20

    Leader Liquid Multivitamin Supplement Recalled for B. cepacia Contamination

    Leader Liquid Multivitamin Supplement for Infants and Toddlers is being voluntarily recalled due to possible contamination with B. cepacia, which can cause serious infections in vulnerable patients.

    Product
    Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3515-2017·2017-09-20

    Rugby Calcionate Syrup Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Calcionate Syrup due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Rugby Calcionate Syrup, One Pint (473 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3531-2017·2017-09-20

    Leader Liquid Vitamin D Supplement Recalled for B. cepacia Contamination

    Leader Liquid Vitamin D Supplement for Breastfed Infants is being voluntarily recalled due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

    Product
    Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3523-2017·2017-09-20

    Rugby Tri-vitamin Liquid Recalled for B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Rugby Tri-vitamin Liquid due to possible contamination with B. cepacia, which poses a risk of serious infection for vulnerable patients.

    Product
    Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2017·2017-09-20

    Bella Pharmaceuticals Recalls Calcium Chloride Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of Calcium chloride 10% vials because the company cannot ensure the product is sterile.

    Product
    Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3109-2017·2017-09-20

    Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure

    Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.

    Product
    Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrilla
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1161-2017·2017-09-20

    Bella Pharmaceuticals Recalls BevaDex Syringes Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 200 prefilled BevaDex syringes nationwide because the company cannot guarantee the product's sterility.

    Product
    BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2017·2017-09-20

    Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.

    Product
    Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2017·2017-09-20

    Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Methylcobalamin 10mg vials because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2017·2017-09-20

    Bella Pharmaceuticals Recalls MIC 25/50/50 Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling MIC 25/50/50 vials because the company cannot ensure the product is sterile. The recall affects 5 vials distributed nationwide.

    Product
    MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2017·2017-09-20

    Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 7 vials of Methylcobalamin 10mg due to a lack of assurance of sterility. The product was distributed nationwide in the United States.

    Product
    Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3545-2017·2017-09-20

    Monster Energy Recalls Java Monster Loco Moca Coffee Due to Processing Error

    Monster Energy Company is recalling Java Monster Loco Moca Coffee & Energy because the product was distributed without undergoing the required retort step.

    Product
    Java Monster Loco Moca Coffee & Energy, Net Wt. 15 fl. oz. (443 mL); UPC 0 70847 81271 5; INGREDIENTS: BREWED COFFEE (FILTERED WATER., COFFEE, CONDENSED SKIM MILK. SUGAR, HEAVY CREAM. GLUCOSE. NATURAL FLAVORS. TAURlNE,. SODIUM CITRATE, MICiOCRYSTALLINE CELLULOSE. PANAX GI
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-3517-2017·2017-09-20

    Rugby Vitamin D3 Liquid Recalled for B. cepacia Contamination Risk

    The Harvard Drug Group is voluntarily recalling Rugby D 3 Vitamin Liquid due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

    Product
    Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1160-2017·2017-09-20

    Bella Pharmaceuticals Recalls Bevacizumab Syringes Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 2,334 Bevacizumab prefilled syringes nationwide due to a lack of assurance of sterility.

    Product
    Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2017·2017-09-20

    Bella Pharmaceuticals Recalls G.A.C Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling G.A.C 25/100/250mg vials because the company cannot ensure the product is sterile.

    Product
    G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3525-2017·2017-09-20

    Major D-Vita Drops Recalled for Possible B. cepacia Contamination

    The Harvard Drug Group is voluntarily recalling Major D-Vita Drops due to possible B. cepacia contamination, which may cause serious infections in vulnerable patients.

    Product
    Major D-Vita Drops, 1 2/3 oz (50 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3543-2017·2017-09-20

    Wegmans Assorted Muffins Recalled for Unlabeled Walnut Allergen

    Wegmans is recalling Assorted Muffins 4-Packs because they may contain walnuts that are not listed on the ingredient label.

    Product
    Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g packaged in clear plastic shell. UPC: 77890-22744 .
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·17V584000·2017-09-20

    Fleetwood Recalls 2013-2016 RVs Due to Battery Tray Weld Defect

    REV Recreation Group is recalling 2013-2016 Fleetwood Bounder and Southwind RVs because insufficient battery tray welds may cause the tray to separate, risking fire or injury.

    Product
    FLEETWOOD — FLEETWOOD SOUTHWIND, BOUNDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2870-2017·2017-09-20

    X-Laser High-Power Laser Projectors Recalled for Safety Standard Non-Compliance

    X-Laser is recalling 830 high-power laser light show projectors because they fail to meet federal performance standards when used in auto and music modes.

    Product
    X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
    Category
    Consumer Product
    Distribution
    0 states
  • HighNHTSA·17V582000·2017-09-20

    Double K Recalls 2016-2017 Hometown Trolley Buses for Seat Belt Defect

    Double K is recalling 2016-2017 Hometown Trolley buses because the seat belt buckle may be stuck in the locked position, preventing the belt from latching.

    Product
    HOMETOWN TROLLEY — HOMETOWN TROLLEY STREETCAR, MAINSTREET, VILLAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3541-2017·2017-09-20

    Tomanetti Pizza Crusts Recalled for Flexible Plastic Contamination

    Tomanetti Food Products is recalling 12-inch homestyle pizza crusts after a consumer complaint reported small pieces of flexible plastic in the product.

    Product
    12" homestyle pizza crusts packed 18 to a case (no consumer packaging) labeled as: Tomanetti Pizza Crusts with the 18-12" Homestyle 9111 block checked.; Keep Frozen; Pizza Crusts; Tomanetti Food Products, 625 Allegheny Avenue, Oakmont, PA 15139 stamped with code: Manufactured da
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-3540-2017·2017-09-20

    Bateman Community Living Recalls Breaded Fish Meal Due to Allergen Mislabeling

    Bateman Community Living is recalling Breaded Fish with Vera Cruz Sauce because wheat and breading ingredients were not listed on the label.

    Product
    Breaded Fish with Vera Cruz Sauce; In 13.4 oz 3 compartment tray that has the fish, rice pilaf and green peas. Item number KD-0003 No labeling on individual trays, only on out box of 4 meals per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-3542-2017·2017-09-20

    Zlotoklos Butter Cookies Recalled for Undeclared Milk Allergen

    Zlotoklos brand butter cookies are being recalled because the packaging lists butter but fails to identify milk as the source, violating FALCPA requirements.

    Product
    Zlotoklos brand Ciastka maslane w czekoladzie (Butter cookies in chocolate), 12.3 oz (350 g). Product is packaged in a plastic tray with foil overwrap, 12 packages per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3130-2017·2017-09-20

    Mako Surgical Recalls Robotic Knee System Due to Software Display Error

    Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.

    Product
    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17228·2017-09-20

    DEMDACO Recalls Infant Bib and Bootie Sets Due to Choking Hazard

    DEMDACO is recalling about 1,500 infant bib and bootie sets because rattle attachments can detach, posing a choking hazard. No injuries have been reported.

    Product
    Infant bib and bootie sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3117-2017·2017-09-20

    Zimmer Biomet Recalls ROSA Surgical Device Foot Switches

    Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.

    Product
    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electrom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3133-2017·2017-09-20

    Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues

    Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.

    Product
    Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3127-2017·2017-09-20

    Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core

    Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.

    Product
    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular
    Category
    Medical Device
    Distribution
    3 states
  • HighCPSC·17227·2017-09-20

    John Deere Recalls D105 Lawn Tractors Due to Transmission Crash Hazard

    John Deere is recalling D105 lawn tractors and service transmissions because the transmission can fail, posing a crash hazard. No injuries have been reported.

    Product
    John Deere D105 lawn tractors and service part transmissions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3126-2017·2017-09-20

    Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue staine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3121-2017·2017-09-20

    Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3115-2017·2017-09-20

    Implant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect

    Implant Direct Sybron is recalling 84 Guided Surgery Handle Kits because the 2.3mm drill guide inserts have a smaller inside diameter than specifications require.

    Product
    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning sof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3125-2017·2017-09-20

    Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.

    Product
    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3111-2017·2017-09-20

    Toshiba Medical Radrex-i Digital Radiography X-ray System Recalled for Software Error

    Toshiba American Medical Systems is recalling 140 Radrex-i digital radiography systems because a software error causes image loss and requires a system reboot.

    Product
    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3118-2017·2017-09-20

    Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover

    Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.

    Product
    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1134-2017·2017-09-20

    Ascend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence

    Ascend Laboratories is recalling 10 mg Amlodipine Besylate tablets because 2.5 mg tablets were found mixed in the bottles.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3122-2017·2017-09-20

    Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.

    Product
    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively ident
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3124-2017·2017-09-20

    Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1136-2017·2017-09-20

    Mid Valley Pharmaceutical Recalls Doctor Manzanilla Cough & Cold Syrup

    Mid Valley Pharmaceutical is recalling Doctor Manzanilla Cough & Cold Syrup due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00316 1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3129-2017·2017-09-20

    Fujifilm Endoscope Corrective Action Following FDA Inspection

    Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.

    Product
    Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3131-2017·2017-09-20

    Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software

    Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.

    Product
    Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1135-2017·2017-09-20

    Mid Valley Recalls Doctor Manzanilla Syrup Due to B. cepacia Risk

    Mid Valley Pharmaceutical is recalling 24 bottles of Doctor Manzanilla Allergy & Decongestant Relief syrup due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1138-2017·2017-09-20

    Medline Recalls Mislabelled Vitamin A&D Ointment Packets

    Medline Industries is recalling Vitamin A&D Ointment packets that are incorrectly labeled as petroleum jelly. The outer boxes are correctly labeled.

    Product
    Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3119-2017·2017-09-20

    bioMerieux Recalls eMAG System Due to Manufacturing Anomalies

    bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.

    Product
    eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3120-2017·2017-09-20

    Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.

    Product
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3116-2017·2017-09-20

    Becton Dickinson Recalls SafetyGlide Needles Due to Foreign Matter

    Becton Dickinson is recalling 1,249,200 units of BD SafetyGlide needles because they contain loose polypropylene foreign matter above release specifications.

    Product
    BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings exte
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-3123-2017·2017-09-20

    Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.

    Product
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autoso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3128-2017·2017-09-20

    Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection

    Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.

    Product
    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other pur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1162-2017·2017-09-20

    Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures

    Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
    Category
    Drug
    Distribution
    2 states

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