The Recall Desk

Archive

September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical
15
Severe
184
High
234
Moderate
81
Low
16

Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

1–100 of 530

  • SevereNHTSA·13V470000·2013-09-30

    Lamborghini Murcielago Recall for Brake Rotor Screw Failure Risk

    Lamborghini is recalling 2006-2010 Murcielago vehicles because brake rotor screws may fail in salty conditions, reducing braking ability and increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI MURCIELAGO, MURCIELAGO ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V477000·2013-09-30

    Charmac Recalls 2006-2007 Trailers Due to Door Lock Jamming Risk

    Charmac Trailers is recalling 2006-2007 Horse, Cargo, and Sports Trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.

    Product
    CHARMAC — CHARMAC HORSE TRAILER, CARGO TRAILER, SPORTS TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V481000·2013-09-30

    Spartan School Bus Chassis Recall for Loose Steering Wheel Nut

    Spartan Motors is recalling 2011-2014 school bus chassis because an insufficiently tightened steering wheel nut may cause loss of vehicle control.

    Product
    SPARTAN — SPARTAN SB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13293·2013-09-30

    Festool Recalls TS 55 REQ Plunge Cut Circular Saws Due to Laceration Hazard

    Festool is recalling about 5,200 TS 55 REQ plunge cut circular saws in the U.S. because the plunge lock can engage unexpectedly, leaving the blade exposed and posing a laceration risk.

    Product
    TS 55 REQ Plunge Cut Circular Saw
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13E053000·2013-09-30

    Emmett Door Recalls RV Doors With Fastec Locks Due to Jamming Risk

    Emmett Door is recalling 4,231 RV doors equipped with Fastec locks where the key can jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    LATCHES/LOCKS/LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V478000·2013-09-30

    ATC Trailers Recalled for Door Lock Defect That May Jam Deadbolt

    Aluminum Trailer Company is recalling 2008-2013 Quest, RSX, and Raven trailers because a door lock defect may jam the deadbolt, trapping occupants inside.

    Product
    ATC — ATC RSX, QUEST, RAVEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V476000·2013-09-27

    Daimler Recalls Orion Buses Due to Electrical Fire Risk

    Daimler Buses North America is recalling 2003-2008 Orion V and 2002-2010 Orion VII buses because electrical components may conduct electricity and cause a fire.

    Product
    ORION — ORION V, VII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V473000·2013-09-27

    Stealth Cargo Trailer Recall for Door Lock Jamming Hazard

    Stealth Enterprises is recalling 2009-2014 cargo trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.

    Product
    STEALTH — STEALTH ALUMINUM BLACKHAWK, ALUMINUM PREDATOR, ALUMINUM MOUNTAINEER, STEEL DAYTONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13292·2013-09-27

    Toys R Us Recalls Journey Girl Travel Trunks Due to Laceration Hazard

    Toys R Us is recalling Journey Girl Travel Trunks because the blue metal handle can be sharp and cause lacerations. Consumers should stop using the trunks and return them for a refund.

    Product
    Journey Girl Travel Trunk
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V466000·2013-09-27

    Dressen Dakota Trailers Recalled for Door Lock Jamming Hazard

    Dressen is recalling 2006-2013 Dakota Cargo and Competitor trailers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    DRESSEN — DRESSEN DAKOTA COMPETITOR, DAKOTA CARGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V458000·2013-09-26

    Altec Aerial Devices Recalled for Potential Fire Risk from Oil Leak

    Altec is recalling 1,145 aerial devices mounted on Ford Super Duty chassis due to an oil leak that could ignite the exhaust thermal blanket.

    Product
    ALTEC — ALTEC AT237, AT30-G, AT200A, AT235
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V464000·2013-09-26

    GM Recalls 2013-2014 Chevrolet Sonic for Fuel Tank Bracket Weld Defect

    General Motors is recalling 2013-2014 Chevrolet Sonic vehicles due to insufficient welds on the front fuel tank strap bracket, which may separate and cause a fuel leak or fire.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V472000·2013-09-26

    Prevost Recalls Buses Due to Incorrect Tire Pressure Certification Plate

    Prevost is recalling specific model year 2005-2014 buses because the certification plate lists incorrect tire inflation pressures, which may lead to overinflation and increased crash risk.

    Product
    PREVOST — PREVOST H3-45, XLII, XLII-45 ENTERTAINER, H3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V474000·2013-09-26

    Volvo Bus Recalls 2013 9700 Coaches for Parking Brake Defect

    Volvo Bus is recalling 2013 9700 coach buses because a manufacturing error may cause the parking brake to fail to fully apply, increasing crash risk.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V447000·2013-09-26

    American Hauler Recalls 2006-2010 Cargo Trailers Due to Door Lock Defect

    American Hauler is recalling 2006-2010 cargo trailers equipped with a specific door lock option that may jam, potentially trapping occupants inside.

    Product
    AMERICAN HAULER — AMERICAN HAULER CARGO TRAILERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V429000·2013-09-26

    Toyota Recalls Sienna Minivans Due to Shift Lock Solenoid Defect

    Toyota is recalling 2004-2005 and 2007-2009 Sienna minivans because the shift lever may move out of Park without the brake pedal being depressed, increasing crash risk.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V430000·2013-09-26

    Nissan Recalls Infiniti M35 and M45 for Accelerator Pedal Defect

    Nissan is recalling 2006-2010 Infiniti M35 and M45 vehicles because the accelerator pedal sensor may fail, causing the engine to stall and increasing crash risk.

    Product
    INFINITI — INFINITI M35, M45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·13V463000·2013-09-26

    GM Recalls 2013-2014 Chevrolet Camaro Coupes for Air Bag Label Defect

    General Motors is recalling 2013-2014 Chevrolet Camaro Coupes because the air bag warning label on the sun visor may peel off, potentially leaving occupants unaware of air bag risks.

    Product
    CHEVROLET — CHEVROLET CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1902-2013·2013-09-25

    JTM Provisions Recalls Bean and Cheese Burrito Filling for Undeclared Eggs

    JTM Provisions Co Inc is recalling 10 lb bags of Bean & Cheese Burrito Filling because the product contains undeclared eggs.

    Product
    Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP FROZEN BEAN & CHEESE BURRITO FILLING***INGREDIENTS: COOKED PINTO BEANS, WATER, CHEDDAR CHEESE***SOYBEAN OIL***STARCH-MODIFIED, ONIONS, CHEESE SAUCE BASE***CONTAINS LESS THAN 2% OF CHILI PEPPER,
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·13V465000·2013-09-25

    Setra Recalls 2011-2014 Motorcoaches Due to Electrical Overload Risk

    Setra is recalling 2011-2014 S417 TC and 2012-2014 S407 CC motorcoaches because an electrical overload in the light control unit may cause a short circuit or vehicle fire.

    Product
    SETRA — SETRA S407 CC, S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1887-2013·2013-09-25

    G. Debbas Chocolatier Recalls Dark Chocolate for Allergen Mislabeling

    G. Debbas Chocolatier is recalling dark chocolate products due to two consumer complaints of allergic reactions. The products were packed in a vegan-declared lunch but the facility processes milk.

    Product
    Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1048-2013·2013-09-25

    Medaus Recalls Testosterone Cyp 200 mg/mL Due to Sterility Concerns

    Medaus, Inc. is recalling Testosterone Cyp 200 mg/mL injections because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1059-2013·2013-09-25

    Avella Recalls Vancomycin and Bevacizumab Due to Sterility Concerns

    Avella Specialty Pharmacy is recalling vancomycin and bevacizumab products due to concerns about sterility assurance with its independent testing laboratory.

    Product
    Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1060-2013·2013-09-25

    Hydroxocobalamin Injection Recalled Due to Failed Sterility Testing

    Northern New England Compounding Pharmacy is recalling one lot of Hydroxocobalamin Injection because third-party testing failed to confirm sterility.

    Product
    Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1051-2013·2013-09-25

    Medaus Recalls L-Glutathione Injection Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1050-2013·2013-09-25

    Medaus Recalls Taurine 50 mg/mL PF Due to Sterility Concerns

    Medaus, Inc. is recalling Taurine 50 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1045-2013·2013-09-25

    JCB Labs Recalls Sodium Citrate Injection Due to Sterility Concerns

    JCB Labs LLC is recalling 397 vials of Sodium Citrate 4% with Gentamicin due to potential microbial contamination and unreliable sterility test results.

    Product
    Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2013·2013-09-25

    Leiter's Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns

    Leiter's Pharmacy is recalling 265 vials of compounded Bevacizumab (Avastin) because a testing lab reported failed sterility results as passing, making the product's sterility unassured.

    Product
    Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V469000·2013-09-25

    Collins Recalls 2009-2010 School Buses Due to Fire Risk

    Collins is recalling 251 school buses from 2009-2010 because voltage spikes may damage electrical components, increasing the risk of a fire.

    Product
    COLLINS — COLLINS SUPER BANTAM, BANTAM, GRAND BANTAM, MID BUS GRAND GUIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2013·2013-09-25

    Leiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 56 vials of Dextrose 50% Injection Solution because sterility cannot be assured after testing errors were discovered.

    Product
    Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2013·2013-09-25

    Medaus Recalls Pyridoxine HCL Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2013·2013-09-25

    Leiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 728 vials of Lidocaine/Phenylephrine PF 1%/1.5% injectible solution because sterility cannot be assured after failed test results were incorrectly reported as passing.

    Product
    Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2188-2013·2013-09-25

    B. Braun Outlook ES Infusion Pumps Recalled for Display Error

    B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1055-2013·2013-09-25

    Medaus Recalls NA Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling NA Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2013·2013-09-25

    Medaus Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Medaus, Inc. is recalling Magnesium Chloride 200 mg/mL PF, 100 mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1049-2013·2013-09-25

    Medaus Recalls Lipo-Injection Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection w/ Lidocaine because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1044-2013·2013-09-25

    JCB Labs Recalls Sodium Thiosulfate Injection Due to Sterility Concerns

    JCB Labs LLC is recalling 1,056 vials of Sodium Thiosulfate 25% injection because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2013·2013-09-25

    Leiter's Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns

    Leiter's Pharmacy is recalling 810 vials of Hyaluron (hyaluronidase) 150 units/mL due to bacterial contamination and unverified sterility.

    Product
    Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1043-2013·2013-09-25

    JCB Labs Recalls Acetylcysteine Solution Due to Sterility Concerns

    JCB Labs LLC is recalling 903 vials of Acetylcysteine 20% Solution because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1047-2013·2013-09-25

    JCB Labs Recalls Epinephrine Syringes Due to Sterility Concerns

    JCB Labs LLC is recalling 1,243 epinephrine syringes because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2013·2013-09-25

    JCB Labs Recalls Sodium Citrate Injection Vials Due to Sterility Concerns

    JCB Labs LLC is recalling 677 vials of Sodium Citrate 4% Solution for Injection because laboratory results indicate microbial contamination and sterility cannot be assured.

    Product
    Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1908-2013·2013-09-25

    Tampa Maid Recalls Breaded Scallops Due to Incorrect Ingredient Labeling

    Tampa Maid Foods is recalling 142 cases of Portico Brand Breaded Scallops because the ingredient labeling is incorrect. The product was distributed in Virginia and Tennessee.

    Product
    Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: "Portico Brand 4/3 lb 170585 Breaded Scallops***Net Wt 12 lb (5.44 kg)***Ingredients:Scallops, Bleached Wheat Flour, Water, Modified Corn Starch, Sugar, Yellow Corn Flour, Salt, Textured Soy Flour, Y
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1054-2013·2013-09-25

    Medaus Recalls Sodium Ascorbate Injection Due to Sterility Concerns

    Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1884-2013·2013-09-25

    Tasty Bake Frozen Dough Balls Recalled for Cryptosporidium Contamination Risk

    Tasty Bake Inc. is recalling frozen dough balls processed with Baker City, Oregon water due to potential Cryptosporidium contamination following a local boil water notice.

    Product
    Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually wrapp
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2199-2013·2013-09-25

    Tornier Recalls Aequalis Reversed II and Fracture Impactors

    Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.

    Product
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2236-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 1,643 TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1889-2013·2013-09-25

    G. Debbas Chocolatier Recalls Dark Chocolate with Orange Due to Allergen Mislabeling

    G. Debbas Chocolatier is recalling Dark Chocolate with Orange pieces because they were packed in a vegan-labeled lunch containing milk.

    Product
    Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2213-2013·2013-09-25

    Rauland-Borg Recalls Responder 5 Nurse Call Systems Due to Counterfeit Parts

    Rauland-Borg is recalling Responder 5 nurse call systems because counterfeit electronic components may cause the devices to lose communication functionality.

    Product
    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier. The recall covers 10,296 units distributed worldwide.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems p
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2200-2013·2013-09-25

    Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification

    Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.

    Product
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue

    Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-1897-2013·2013-09-25

    Combs Produce Recalls Round Fresh Tomatoes Due to E. coli Risk

    Combs Produce is recalling 8,075 lbs of Round Fresh Tomatoes sold in 20-lb bulk boxes due to potential E. coli O157:H7 contamination.

    Product
    Round Fresh Tomatoes sold in bulk boxes, 20 lbs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1899-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake for Undeclared Food Dyes

    Jean's Cake is recalling Coffee Cake: queso crema (creme cheese) due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    Coffee Cake: queso crema (creme cheese)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2241-2013·2013-09-25

    GE Healthcare recalls READY View fMRI software due to incorrect maps

    GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.

    Product
    GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2216-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2013·2013-09-25

    Churchill Medical Systems Recalls Central Dressing Change Kits

    Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.

    Product
    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionecto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2013·2013-09-25

    Laserworld Laser Light Show Projectors Recalled for Missing Safety Labels

    Laserworld USA Inc. is recalling RGB and Piko Nano RGB laser light show projectors due to missing laser safety warnings and incomplete user information.

    Product
    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
    Category
    Consumer Product
    Distribution
    5 states
  • HighFDA (Food)·F-1895-2013·2013-09-25

    American Yeast Recalls Bulk Liquid Yeast Cream Due to Salmonella Contamination

    American Yeast Corporation is recalling bulk liquid yeast cream distributed to Maryland, Connecticut, Pennsylvania, and New York because it is contaminated with Salmonella.

    Product
    Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2221-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1901-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake Due to Undeclared Allergens

    Jean's Cake is recalling Coffee Cake: queso/manzana (cheese/apple) because it contains undeclared Yellow #5 and Yellow #6.

    Product
    Coffee Cake: queso/manzana (cheese/apple)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2224-2013·2013-09-25

    Smith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2013·2013-09-25

    General Mills Recalls Pillsbury Cinnamon Rolls Due to Plastic Fragments

    General Mills is recalling specific cans of Pillsbury Cinnamon Rolls with Icing because the dough may contain fragments from a broken piece of plastic on the production line.

    Product
    Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G.
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-2239-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2013·2013-09-25

    Synthes Cannulated Distal Femoral Nail Recalled Due to Prior Recall Scope

    Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.

    Product
    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2238-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1882-2013·2013-09-25

    Frozen Hot Smoked Salmon Recalled for Missing Storage Instructions

    Mike's Quality Meats, Inc. is recalling frozen hot smoked salmon due to missing storage instructions on the label, which could allow Clostridium botulinum to grow.

    Product
    Frozen Hot Smoked Vacuum Packed Salmon
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2247-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can cause shortened APTT clotting times.

    Product
    ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-1900-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake Due to Undeclared Allergens

    Jean's Cake is recalling Coffee Cake: queso/fresa because it contains undeclared Yellow #5 and Yellow #6. The product was distributed only in Puerto Rico.

    Product
    Coffee Cake: queso/fresa (cheese/strawberry)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2246-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems prov
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2222-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2013·2013-09-25

    Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors

    Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.

    Product
    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2249-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue

    Instrumentation Laboratory is recalling 662 ACL TOP 300 and ACL TOP 300 CTS analyzers worldwide due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2257-2013·2013-09-25

    GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk

    GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1893-2013·2013-09-25

    Lucy's Kitchen Recalls Superpan Tu Pan Natural for Undeclared Wheat

    Lucy's Kitchen, Inc. is recalling Superpan Tu Pan Natural because the ingredient list declares 'semolina durum' but omits the common name 'wheat', an undeclared allergen.

    Product
    "***SUPERPAN***Tu Pan Natural***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2233-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems prov
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2231-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2013·2013-09-25

    Churchill Medical Recalls Vygon 14 Microbore Extension Sets

    Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.

    Product
    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2013·2013-09-25

    Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect

    Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.

    Product
    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.

    Product
    GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2013·2013-09-25

    Ebi Recalls Cypher MIS Screw System Due to Screw Head Splay

    Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.

    Product
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
    Category
    Medical Device
    Distribution
    Distributed nationwide

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