The Recall Desk

Archive

December 2017 recalls

389 recalls were announced in December 2017.

What the numbers show

Critical
38
Severe
74
High
172
Moderate
94
Low
11

Of the 389 recalls this month scored against our rubric, 10% are Critical, 19% are Severe.

Which agencies issued them

101–200 of 389

  • SevereFDA (Devices)·Z-0241-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included Greatbatch introducer sheaths have handles that may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V823000·2017-12-20

    Alfa Romeo Giulia and Stelvio Recalled for Brake Fluid Contamination

    FCA US LLC is recalling 2018 Alfa Romeo Giulia and Stelvio vehicles because contaminated brake fluid may damage the braking system and reduce performance.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA, STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V832000·2017-12-20

    Wabash National Truck Body Recall for Missing Weld on Support

    Wabash National is recalling 2018 Truck Body vehicles because a missing weld on the vertical leg support increases injury risk in rear-end collisions.

    Product
    WABASH NATIONAL — WABASH NATIONAL TRUCK BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V821000·2017-12-20

    FCA Recalls Ram Trucks Due to Transmission Shift Interlock Defect

    FCA is recalling specific Ram trucks because the brake transmission shift interlock pin may stick, allowing the vehicle to shift out of park without the brake pedal or key, increasing rollaway risk.

    Product
    RAM — RAM, DODGE 2500, 4500, 3500, RAM 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0242-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths have handles that may detach during use.

    Product
    XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intrav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V833000·2017-12-20

    Walker Recalls 2018 Tank Trailers Due to Brake Caliper Bolt Issues

    Walker is recalling 2018 Tank Trailers because improperly torqued brake caliper bolts may allow the caliper to detach, causing a loss of braking ability.

    Product
    WALKER — WALKER TANK TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0490-2018·2017-12-20

    Wang Globalnet Recalls Fish Tofu for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Tofu in Polybag 40/240g because the product contains undeclared egg and wheat allergens.

    Product
    Fish Tofu in Polybag 40/240g, Item no. 17185, UPC Code 087703171855
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0488-2018·2017-12-20

    Wang Globalnet Fish Cake Recalled for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Cake in Polybag due to undeclared egg and wheat ingredients. The product was distributed to several Northeastern and Mid-Atlantic states.

    Product
    Fish Cake in Polybag 20/1lb., Item no. 13125 UPC Code 087703131256
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0109-2018·2017-12-20

    Sun Pharmaceutical Recalls Riomet Metformin Solution Due to Microbial Contamination

    Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to microbial contamination. The recall covers specific lots of the cherry-flavored prescription liquid.

    Product
    RIOMET — RIOMET (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0252-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2018·2017-12-20

    Radiometer ABL800 Analyzer Recalled for Barcode Misinterpretation

    Radiometer America Inc. is recalling 1,749 ABL800 analyzers because a barcode scanner error may display results from a different patient.

    Product
    ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2018·2017-12-20

    Ortho-Clinical enGen Track System Software Recall for Result Delays

    Ortho-Clinical Diagnostics is recalling 16 enGen Track Systems with TCAutomation Software Version 4.2 due to a software anomaly that may delay result reporting.

    Product
    enGen Track System with TCAutomation Software Version 4.2
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0228-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0495-2018·2017-12-20

    JLM Manufacturing Recalls Dark Chocolate Raisins for Undeclared Milk

    JLM Manufacturing LLC is recalling Dark Chocolate Raisins due to undeclared milk and butterfat. The products were distributed to multiple states.

    Product
    Dark Chocolate Raisins, Natural Dark Chocolate Raisins
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0250-2018·2017-12-20

    Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment

    Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0443-2018·2017-12-20

    Colorado Nut Co Recalls Honey Nutty Granola for Undeclared Milk

    Colorado Nut Co is recalling Honey Nutty Granola because it contains undeclared milk. Consumers with the product should stop eating it.

    Product
    Honey Nutty Granola (8 oz. bag), UPC 018142352147. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0487-2018·2017-12-20

    Sichuan Youjia Bamboo Shoots Sauce Recalled for High Water Activity

    Sichuan Youjia Foodstuffs Co., Ltd is recalling 40 cases of Bamboo Shoots Sauce found with water activity above .85.

    Product
    BAMBOO SHOOTS SAUCE (Marinated Bamboo) packaged in a glass jar, net wt. 220g. UPC: 6 930841 008230
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0483-2018·2017-12-20

    Tops Dark Chocolate Coffee Beans Recalled for Undeclared Milk

    First Source, LLC is recalling Tops Dark Chocolate Coffee Beans because they contain undeclared milk, a major allergen.

    Product
    Tops Dark Chocolate Coffee Beans Net Wt 12 OZ (340g) UPC: 0 70784 51027 9
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0247-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0489-2018·2017-12-20

    Wang Globalnet Recalls Fish Balls for Undeclared Egg and Wheat

    Wang Globalnet is recalling Fish Ball in Polybag 24/12oz. because the product contains undeclared egg and wheat.

    Product
    Fish Ball in Polybag 24/12oz., Item no. 20072, UPC Code 087703200722
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0239-2018·2017-12-20

    FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking

    The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.

    Product
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical P
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0240-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2018·2017-12-20

    Fujifilm FDR Visionary Suite X-ray Tube Recall for Cracking Risk

    Fujifilm is recalling three FDR Visionary Suite systems because cracks may develop in the X-ray tube holding shaft, posing a potential safety issue.

    Product
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts o
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0235-2018·2017-12-20

    Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results

    Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.

    Product
    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provid
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0249-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the introducer handles may detach from the sheath during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2018·2017-12-20

    Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping

    Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.

    Product
    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17E078000·2017-12-20

    Eaton Cummins Transmission Recall for Unintended Vehicle Movement Risk

    Eaton Cummins is recalling specific Endurant and PACCAR transmissions where the control module may allow the engine to crank if the shifter is not in neutral, increasing crash risk.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE (TCM/PCM/TECM) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0479-2018·2017-12-20

    First Source Recalls Dark Chocolate Almonds for Undeclared Milk

    First Source, LLC is recalling Dark Chocolate Almonds sold under multiple brands because the products contain undeclared milk.

    Product
    Dark Chocolate Almonds packaged under the brand names: (1)Wegmans, 23 OZ (1 LB 7 OZ) 652g tub UPC: 0 77890 328200 4 and 11.5 oz. (326g) tub UPC: 0 70784 50743 9; (2)Alpine Valley 11.5 OZ (326 g). tub UPC 0 23637 41099 8; (3)Tops 11.5oz . tub (326 g) UPC: 0 70784 50743 9; (4) C
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0224-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V837000·2017-12-20

    Nissan Recalls 2018 Versa Note Vehicles for Side Air Bag Defect

    Nissan is recalling 2018 Versa Note vehicles because a side curtain air bag component may detach during deployment, posing a projectile hazard.

    Product
    NISSAN — NISSAN VERSA NOTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0442-2018·2017-12-20

    Colorado Nut Co Recalls Oat Bran Nutty Crunch for Undeclared Milk

    Colorado Nut Co is recalling Oat Bran Nutty Crunch snack mix because it contains undeclared milk, a major food allergen.

    Product
    Oat Bran Nutty Crunch (8 oz. bag), UPC 018142352130. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0444-2018·2017-12-20

    Colorado Nut Co Recalls Peanut Delight for Undeclared Milk

    Colorado Nut Co is recalling Peanut Delight snack bags due to undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Peanut Delight (8 oz. bag), UPC 018142352512. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0484-2018·2017-12-20

    Favourites Dark Chocolate Covered Almonds Recalled for Undeclared Milk

    First Source, LLC is recalling Favourites Dark Chocolate Covered Almonds because they contain undeclared milk. The products were distributed in 23 US states and Canada.

    Product
    (Canada) - Favourites Dark Chocolate Covered Almonds 113 grams UPC: 0 23637 42849 8 & 92grams UPC: 0 2367 42864
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0445-2018·2017-12-20

    Frontier Trail Mix Recalled for Undeclared Milk Allergen

    Colorado Nut Co is recalling Frontier Trail Mix because it contains undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Frontier Trail Mix (4 oz. bag), UPC 018142352987. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0494-2018·2017-12-20

    JLM Manufacturing Recalls Dark Chocolate Coffee Beans for Undeclared Milk

    JLM Manufacturing LLC is recalling dark chocolate coffee beans due to undeclared milk and butterfat. The products were distributed to multiple states.

    Product
    Dark Chocolate Coffee Beans, Natural Dark Chocolate Coffee Beans
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0230-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Slender Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intrav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2018·2017-12-20

    First Source Recalls Chocolate Almonds for Undeclared Milk

    First Source, LLC is recalling Wegmans and 7 Select dark chocolate almond products because they contain undeclared milk.

    Product
    (1)Wegmans Dark Chocolate Almonds with Sea Salt and Turbinado Sugar 12oz. tub (340g) UPC: 0 77890 37539 6 (2) 7 Select Dark Chocolate Turbinado Almonds with Sea Salt 2.25 OZ (63g) bag UPC: 0 52548 59131 1
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0481-2018·2017-12-20

    Wegmans Dark Chocolate Cherry Cranberries Recalled for Undeclared Milk

    First Source, LLC is recalling Wegmans Dark Chocolate Cherry Infused Cranberries because the product contains undeclared milk.

    Product
    Wegmans Dark Chocolate Cherry Infused Cranberries 12 OZ (340g) tub UPC: 0 77890 33741 7
    Category
    Food
    Distribution
    23 states
  • HighNHTSA·17V831000·2017-12-20

    Toyota Recalls Vehicles with Incorrect Load Capacity Labels

    Toyota is recalling 2017-2018 models due to incorrect load carrying capacity labels that may lead to vehicle overloading and increased crash risk.

    Product
    TOYOTA — TOYOTA, LEXUS TUNDRA, 4RUNNER, SIENNA, TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0455-2018·2017-12-20

    Kellbran Drizzled Vanilla Popcorn Recalled for Undeclared Soy Allergen

    Kellbran Candies and Snacks Inc is recalling 520 bags of Drizzled Vanilla Popcorn because soy was not declared in the ingredient statement.

    Product
    DRIZZLED VANILLA POPCORN Net Wt. 3 oz (84.9g) Ingredients: Popcorn, corn syrup, sugar, lecithin***ALLERGY INFO: Manufactured in a facility that processes Milk, Wheat, Soy, Tree Nuts, Peanuts Stew Leonard's 100 Westport Ave., Norwalk, CT
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0485-2018·2017-12-20

    First Source Recalls Dark Chocolate Almonds for Undeclared Milk

    First Source, LLC is recalling Circle K Favourites Dark Chocolate Covered Almonds because they contain undeclared milk. The product was distributed in 23 U.S. states and Canada.

    Product
    (Canada) Circle K Favourites Dark Chocolate Covered Almonds 113grams UPC: 0 2367 42849
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0498-2018·2017-12-20

    JLM Manufacturing Recalls Dark Chocolate Almonds for Undeclared Milk

    JLM Manufacturing LLC is recalling Dark Chocolate Almonds due to undeclared milk and butterfat. The products were distributed to multiple states.

    Product
    Dark Chocolate Almonds, Natural Dark Chocolate Almonds, 12/7 oz., and 12/12 oz.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-0482-2018·2017-12-20

    Wegmans Dark Chocolate Strawberries Recalled for Undeclared Milk

    First Source, LLC is recalling Wegmans Dark Chocolate Strawberries because the product contains undeclared milk, a major food allergen.

    Product
    Wegmans Dark Chocolate Strawberries 13.5oz (383g) tub, UPC: 0 77890 38187 8
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0441-2018·2017-12-20

    Colorado Nut Co Recalls Cashew Cranberry Cherry Jubilee for Undeclared Milk

    Colorado Nut Co is recalling Cashew Cranberry Cherry Jubilee snack mix because it contains undeclared milk, a major food allergen.

    Product
    Cashew Cranberry Cherry Jubilee (8 oz. bag), UPC 018142352161. Packaged in Plastic Zip Lock bags. No refrigeration needed.
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0214-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0187-2018·2017-12-20

    Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors

    Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0186-2018·2017-12-20

    Physio-Control Recalls Defibrillation Electrodes Due to Incorrect Pad Placement Artwork

    Physio-Control is recalling 14,219 LIFEPAK defibrillation electrodes because the artwork instructs incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheath Due to Incomplete Seal

    Terumo Medical Corp is recalling a specific lot of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2018·2017-12-20

    United Nuclear Scientific Recalls Three High Power Handheld Lasers

    United Nuclear Scientific Supplies, LLC is recalling three high power handheld laser products for failing to comply with laser class limitations.

    Product
    United Nuclear Scientific High Power Handheld Lasers. Laser products
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0233-2018·2017-12-20

    Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons

    Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.

    Product
    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0223-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0221-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete packaging seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0486-2018·2017-12-20

    Gourmet International Recalls Premio Strawberry Pralinati for Undeclared Colors

    Gourmet International Inc. is voluntarily recalling Premio Strawberry Pralinati cookies due to undeclared colors. The recall covers 24,179 cases distributed in several US states.

    Product
    Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in Paper Cartons
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0253-2018·2017-12-20

    ConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error

    ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system because they were manufactured with the incorrect anchor outer body.

    Product
    Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0237-2018·2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0219-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2018·2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0217-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0108-2018·2017-12-20

    Teva Recalls Penicillin V Potassium Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific bottles of Penicillin V Potassium oral solution because they failed impurity and degradation specifications.

    Product
    PENICILLIN V POTASSIUM — PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V825000·2017-12-19

    2018 Coachmen Galleria Motorhomes Recalled for Wiring Fire Risk

    Forest River is recalling 2018 Coachmen Galleria motorhomes because an inverter lead wire may melt, increasing the risk of a fire.

    Product
    COACHMEN — COACHMEN GALLERIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V829000·2017-12-19

    REV Recalls 2018 Motorhomes Due to Electrical Wiring Short Risk

    REV Recreation Group is recalling 347 specific 2018 motorhomes because water may enter 12-volt harness connectors, potentially causing an electrical short and increasing the risk of a crash.

    Product
    MONACO — MONACO, AMERICAN COACH, HOLIDAY RAMBLER MARQUIS, AMERICAN REVOLUTION, AMERICAN DREAM, ENDEAVOR XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V830000·2017-12-19

    Newmar Recalls 2016-2018 Motorhomes for Electrical Fire Risk

    Newmar is recalling 2,915 model year 2016-2018 motorhomes because a loose power connection at the Automatic Transfer Switch may cause heat buildup and increase the risk of a fire.

    Product
    NEWMAR — NEWMAR CANYON STAR, KING AIRE, BAY STAR, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E077000·2017-12-19

    A.L. Solutions Recalls Diesel Fuel Filters Due to Leak Risk

    A.L. Solutions is recalling aftermarket diesel fuel filters because a thread mismatch may cause improper sealing and fuel leaks, increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:FUEL FILTER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V814000·2017-12-18

    Ford Recalls 2018 Mustangs for Instrument Cluster Software Defect

    Ford is recalling 2018 Mustangs with automatic transmissions because the instrument cluster may fail to display the gear position or provide an audible warning when the ignition is off, increasing the risk of the vehicle rolling away.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V819000·2017-12-18

    Mercedes-Benz Recalls 2016-2017 GLC Models for Headlight Adjustment Defect

    Mercedes-Benz is recalling 2016-2017 GLC300 and GLC43 vehicles because misadjusted headlights may not illuminate the roadway properly, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC43, GLC300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V826000·2017-12-18

    Mercedes-Benz Recalls 2018 AMG GT Models for Seat Belt Binding Defect

    Mercedes-Benz is recalling 1,263 model year 2018 AMG GT vehicles because seat belts may bind, causing slack that increases injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT S, AMG GT, AMG GT R, AMG GT C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V816000·2017-12-18

    Mercedes-Benz Recalls 8,700 Vehicles for Rear Door Lock Defect

    Mercedes-Benz is recalling 8,700 vehicles because the rear driver-side door may appear locked when it is not, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH S63, S600, S550, S65 AMG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V818000·2017-12-18

    Mercedes-Benz Recalls AMG GT Models for Passenger Airbag Sensor Defect

    Mercedes-Benz is recalling certain 2017-2018 AMG GT models because the passenger airbag sensor may malfunction, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT C ROADSTER, AMG GT, AMG GT ROADSTER, AMG GT S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V828000·2017-12-18

    Mercedes-Benz Recalls GLE 550e Vehicles for Incorrect Tire Pressure Labels

    Mercedes-Benz is recalling 2016-2017 GLE 550e 4MATIC vehicles because the B-pillar tire pressure label lists incorrect seating capacity and tire dimensions, violating federal safety standards.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE550E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·129-2017·2017-12-16

    Piller's Fine Foods Recalls Ready-to-Eat Salami and Speck Due to Salmonella

    Piller's Fine Foods is recalling approximately 1,076 pounds of ready-to-eat salami and speck products due to possible Salmonella contamination. The products were distributed in five U.S. states.

    Product
    Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·17V812000·2017-12-15

    Ducati Recalls Motorcycles Due to Front Brake Master Cylinder Failure Risk

    Ducati is recalling specific 2015-2018 motorcycles because front brake master cylinders may fail, increasing crash risk. Dealers will replace the piston free of charge.

    Product
    DUCATI — DUCATI SCRAMBLER 800 CAFE RACER, XDIAVEL S, MONSTER 1200, PANIGALE R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E074000·2017-12-15

    Lippert Smart Jack Power Tongue Jack Recall for Unintended Movement

    Lippert is recalling Smart Jack model 426514 Power Tongue Jacks because the touch pad can crack, allowing water entry that causes the jack to move unexpectedly.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide

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