The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
132
High
403
Moderate
173
Low
33

Of the 802 recalls this month scored against our rubric, 8% are Critical, 16% are Severe.

101–200 of 802

  • ModerateFDA (Devices)·Z-0641-2017·2016-11-30

    Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.

    Product
    2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0483-2017·2016-11-30

    Infiniti Creations Recalls HCG Plus Drops Due to Misbranding

    Infiniti Creations, LLC is voluntarily recalling HCG Plus drops due to misbranding and potential undeclared HCG content.

    Product
    HCG Plus. 2oz HCG Drops. Blue Glass
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0148-2017·2016-11-30

    Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content

    Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.

    Product
    KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0637-2017·2016-11-30

    Synthes Recalls 2.5 mm Reaming Rods Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 1,951 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0151-2017·2016-11-30

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0145-2017·2016-11-30

    Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels

    Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.

    Product
    CEFTRIAXONE SODIUM — CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0639-2017·2016-11-30

    Synthes Recalls 3.0 mm Reaming Rods Due to Pouch Delamination

    Synthes (USA) Products LLC is recalling 5,478 sterile 3.0 mm reaming rods because their peel pouches are delaminating.

    Product
    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0147-2017·2016-11-30

    West-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel

    West-Ward Pharmaceuticals is recalling 32,102 bottles of Amoxicillin oral suspension because some bottles are missing the color-coded panel that displays the product strength.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V857000·2016-11-29

    Van Hool Motorcoaches Recalled for Steering Knuckle Carrier Cracking

    Van Hool is recalling specific motorcoaches because front steering knuckle carriers may crack, potentially causing a wheel to separate and increasing crash risk.

    Product
    VAN HOOL — VAN HOOL CX45, TD925, TDX25, CX35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17039·2016-11-29

    Gree Recalls 2.5 Million Dehumidifiers Due to Fire and Burn Hazards

    Gree Electric Appliances is recalling approximately 2.5 million dehumidifiers sold under various brands because they can overheat and catch fire, posing serious fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17038·2016-11-29

    Stanley Commercial Door Locksets Recalled Due to Entrapment Risk

    Stanley is recalling about 70,000 commercial door locksets because the latches can fail, preventing doors from being unlocked from the inside during an emergency.

    Product
    Door locksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V858000·2016-11-29

    Toyota Recalls 2011-2016 Sienna Minivans for Power Sliding Door Defect

    Toyota is recalling 2011-2016 Sienna minivans because the power sliding door may open unexpectedly while the vehicle is moving, increasing the risk of injury to occupants.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V860000·2016-11-29

    StarTrans PS2 Transit Buses Recalled for Brake Indicator Malfunction

    Forest River is recalling 2016-2017 StarTrans PS2 buses because the instrument cluster may display 'PARK' instead of 'BRAKE' during a brake malfunction, increasing crash risk.

    Product
    STARTRANS — STARTRANS PS2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V855000·2016-11-28

    Autocar Recalls 2013-2017 Xpeditor Vehicles for Engine Stall Risk

    Autocar is recalling 2013-2017 Xpeditor vehicles because fuse box vibration may cause the ignition relay to open, leading to an engine stall and increased crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V853000·2016-11-28

    Mercedes-Benz Sprinter Recall for Defective Left Seat Adjusters

    Midwest Automotive Designs is recalling 2016 Mercedes-Benz Sprinter 2500 and 3500 vans because certain left seat adjusters may allow seats to move during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V852000·2016-11-28

    Autocar Recalls Xpeditor Vehicles for Hybrid Drive Unit Bolt Defect

    Autocar is recalling 2012-2016 Xpeditor vehicles because hybrid power drive unit bolts may not be tightened properly, risking detachment and crashes.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V856000·2016-11-28

    Maserati Recalls 2017 Quattroporte and Ghibli for Rear Differential Defect

    Maserati is recalling 326 model year 2017 Quattroporte and Ghibli vehicles because a loose rear differential pinion nut may cause the rear wheels to lock up, increasing crash risk.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V854000·2016-11-28

    KTM Recalls 2013-2016 Adventure Motorcycles for Brake Line Melting Risk

    KTM is recalling specific 2013-2016 Adventure and Super Adventure motorcycles because a fraying wiring harness can melt the brake line, potentially causing brake failure.

    Product
    KTM — KTM 1190 ADVENTURE, 1190 ADVENTURE R, 1290 SUPER ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V851000·2016-11-25

    Gulf Stream Motorhomes Recalled for Improperly Wired In-Dash Radio Assembly

    Gulf Stream is recalling 2016-2017 Conquest and B Touring Cruiser motorhomes because the in-dash radio assembly was improperly wired, allowing the DVD to operate while the vehicle is in motion.

    Product
    GULF STREAM — GULF STREAM B TOURING CRUISER, CONQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0449-2017·2016-11-23

    C.F. Sauer Recalls Marcum Chili Powder Due to Peanut Contamination

    C.F. Sauer Company is recalling Marcum Chili Powder because a specific lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    MARCUM CHILl POWDER, 2.25 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0446-2017·2016-11-23

    Sauer's Hot Chili Powder Recalled for Peanut Contamination

    C.F. Sauer Company is recalling Sauer's Hot Chili Powder because a cumin ingredient tested positive for peanut protein.

    Product
    SAUER'S HOT CHILl POWDER, 2.25oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0444-2017·2016-11-23

    C.F. Sauer Recalls Barbeque Spice Due to Peanut Contamination

    C.F. Sauer Company is recalling Sauer's Barbeque Spice because a lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    SAUER'S BARBEQJ E SPICE, 3 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0451-2017·2016-11-23

    C.F. Sauer Recalls Ground Cumin Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of ground cumin because the raw ingredient tested positive for peanut protein.

    Product
    SAUER'S GROUND CUMIN,5lbs . CHEF'S MAGIC GROUND CUMIN, 5 lbs. CODE GROUND CUMIN, 5 lbs. JAKE'S GROUND CUMIN,5 lbs. PREMIUM RECIPE GROUND CUMIN,5 lbs RESTAURANT PRIDE GROUND CUMIN,5 lbs.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0448-2017·2016-11-23

    C.F. Sauer Recalls Ground Cumin Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of Marcum Ground Cumin because a purchased lot tested positive for peanut protein.

    Product
    MARCUM GROUND CUMIN, 2.25 o z.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0447-2017·2016-11-23

    C.F. Sauer Recalls Multiple Chili Powder Brands Due to Peanut Contamination

    C.F. Sauer Company is recalling multiple brands of 5.5 lb chili powder because a specific lot of ground cumin seed used in the product tested positive for peanut protein.

    Product
    SAUER'S CHILl POWDER, 5.5 lbs. BLUE MOUNTAIN VALLEY CHILl POWDER, 5.5 lbs. CHEF'S MAGIC CHILl POWDER, 5.5 lbs. CODE CHILl POWDER, 5.5 lbs. IFH CHILI POWDER,5.5 lbs. NUGGET CHILl POWDER,5.5 lbs. POCAHONTAS CHILl POWDER, 5.5 lbs. PREMIUM RECIPE CHILl POWDER…
    Category
    Food
    Distribution
    0 states
  • CriticalUSDA FSIS·115-2016·2016-11-23

    National Steak and Poultry Recalls Undercooked Ready-to-Eat Chicken

    National Steak and Poultry is recalling approximately 17,439 pounds of ready-to-eat chicken products that may be undercooked, posing a risk of bacterial pathogens.

    Product
    National Steak Processors (2024), LLC. — National Steak and Poultry Recalls Food Service Ready-To-Eat Chicken That May Be Undercooked
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0453-2017·2016-11-23

    C.F. Sauer Recalls Gold Medal Chili Powder Due to Peanut Contamination

    C.F. Sauer Company is recalling specific lots of Gold Medal Chili Powder and Restaurant Pride Chili Powder because a cumin ingredient tested positive for peanut protein.

    Product
    GOLD MEDAL CHILl POWDER,5.5 lbs RESTAURANT PRIDE DEPENDABLE CHILl POWDER, 5.5 lbs
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·16V850000·2016-11-23

    Kalmar Recalls 2014-2016 Ottawa T2 Vehicles for Fire Risk

    Kalmar is recalling 798 model year 2014-2016 Ottawa T2 vehicles because an overloaded ground circuit may increase the risk of a dashboard fire.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0454-2017·2016-11-23

    Turkey Hill Rocky Road Ice Cream Recalled for Unlabeled Allergens

    Turkey Hill Dairy is recalling Rocky Road ice cream because it may contain unlabeled almonds and eggs, posing a risk of severe allergic reactions.

    Product
    On Lid: Turkey Hill, Rocky Road, 48 FL. OZ.. In small letters at the top of the lid reads: "Dutch Chocolate ice cream swirled with whipped marshmallow and butter-roasted almonds" On body of Tub: Turkey Hill Rocky Road, 48 FL. OZ. On bottom of Tub: Sell By May 23, 2017…
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0141-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0433-2017·2016-11-23

    McCain Foods Recalls Frozen Onion Rings for Undeclared Milk

    McCain Foods USA is recalling frozen onion rings sold under six private label brands because the product label does not declare milk.

    Product
    Frozen Onion Rings sold and distributed under the following private label retail brands: 1) Premium Pick 5 Mix and Match Onion Rings, NET WT 40 OZ, packaged in plastic bags; 2) Krasdale Onion Rings, NET WT 16 OZ, packaged in plastic bags; 3) Spartan Onion Rings, NET WT 20…
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-0487-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0140-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·114-2016·2016-11-23

    Nick's of Calvert Recalls Meatballs for Undeclared Allergens

    Nick's of Calvert is recalling 305 pounds of meatballs sold in Maryland due to missing production information and undeclared eggs and milk.

    Product
    Nick's of Calvert Recalls Meatball Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0476-2017·2016-11-23

    Prime Time International Recalls Cucumbers Due to Salmonella Risk

    Prime Time International is recalling cucumbers because they may be contaminated with Salmonella.

    Product
    PRIME TIME Cucumbers, 1 & 1/9 BUSHEL CARTON, 25kg per carton, TAG ID# 10173318, 10173319, 10173320, 10173322.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0508-2017·2016-11-23

    ICU Medical Recalls Pediatric CVL Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 Pediatric CVL Monitoring Kits containing Transpac IV transducers due to a potential for leak.

    Product
    PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0602-2017·2016-11-23

    Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect

    Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

    Product
    Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 160 units of Transpac IV transducer kits due to a potential leak. The affected products were distributed nationwide.

    Product
    TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling Transpac IV bifurcated monitoring kits because of a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2017·2016-11-23

    Mevion S250 Proton Therapy Systems Recalled for Isocenter Error Risk

    Mevion Medical Systems is recalling six MEVION S250 proton radiation therapy units because completing setup without a program move can cause an isocenter error.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 25 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0471-2017·2016-11-23

    Baptista Bakery Torpedo Rolls Recalled for Wheat Flour Mislabeling

    Batista Bakery & Pastries, Inc. is recalling 30 units of Torpedo Rolls because the labels failed to declare wheat flour as required by FALCPA.

    Product
    Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plastic
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0565-2017·2016-11-23

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 200 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 190 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0457-2017·2016-11-23

    Nobel Bakery Recalls Cookies for Undeclared Allergens

    Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk, and soy lecithin.

    Product
    Walnut Nazook and Walnut, Net Wt. 10 oz. (283g), UPC 7 80890 28609 7.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0478-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 80 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 240 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo¿ Flush and Needleless Valve, Item No. 46103-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy Systems Recalled for Isocenter Recovery Issue

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to an operational change affecting the recovery of the incorrect isocenter.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE WITH INFUSION PUMP), Item No. 42634-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 90 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac¿ IV, 72" Spike Sets and 48" HP Tubing, Item No. 46100-83 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 10 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir.

    Product
    Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling specific Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2017·2016-11-23

    ICU Medical Recalls Transpac IV Kits Due to Potential Leak

    ICU Medical is recalling 325 units of Transpac IV Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 130 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

    ICU Medical is recalling 140 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 130 units of Transpac IV Bifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.

    Product
    Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2017·2016-11-23

    ICU Medical Recalls Cardiac Catheterization Kits Due to Leak Risk

    ICU Medical is recalling 70 cardiac catheterization kits containing Transpac IV transducers due to a potential leak in the SafeSet Reservoir system.

    Product
    Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2017·2016-11-23

    Roche Recalls Accu-Chek Connect iOS App Version 1.2.0 Due to Software Bug

    Roche Diabetes Care is recalling version 1.2.0 of the Accu-Chek Connect iOS app because a programming error in the Bolus Advisor feature could lead to incorrect insulin bolus recommendations.

    Product
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0422-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducers and SafeSet Reservoir kits due to a potential for leaks.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0473-2017·2016-11-23

    Baptista Bakery Bulkie Rolls Recalled for Wheat Flour Mislabeling

    Baptista Bakery & Pastries, Inc. is recalling Bulkie Rolls because the labels failed to declare wheat flour as required by FALCPA.

    Product
    Baptista Bakery & Pastry Inc. Bulkie Rolls, 16 oz. plastic
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0433-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential

    ICU Medical is recalling 500 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 30 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 120 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 730 Transpac IV Trifurcated Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 135 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2017·2016-11-23

    Siemens SOMATOM CT Systems Recalled for Loose Light Marker Windows

    Siemens is recalling 762 SOMATOM CT systems because loose light marker windows could allow access to rotating or electrical parts.

    Product
    SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 3,480 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42584-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 3,020 Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 50 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 880 Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak. The products were distributed nationwide.

    Product
    TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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