The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
64
Severe
328
High
307
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 41% are Severe.

701–800 of 807

  • HighFDA (Devices)·Z-2613-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2762-2019·2019-10-09

    Zimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling

    Zimmer GmbH is recalling 19 Sidus Stem-Free Shoulder Humeral Head implants due to incorrect size labeling on the packaging.

    Product
    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s gle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 1,992 units of Vista Dental Sodium Hypochlorite syringes because the rubber bung may degrade when exposed to the bleach solution.

    Product
    Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2765-2019·2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2766-2019·2019-10-09

    Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor

    Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2020·2019-10-09

    Vista Dental Sodium Hypochlorite Syringes Recalled for Bung Degradation

    Inter-Med LLC is recalling Vista Dental 3% Sodium Hypochlorite syringes because the rubber bung may degrade due to chemical interaction with the solution.

    Product
    Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0017-2020·2019-10-09

    Inter-Med Recalls Chlor-XTRA Syringes Due to Bung Degradation Risk

    Inter-Med Llc is recalling specific lots of Chlor-XTRA prefilled syringes because the rubber bung may degrade when exposed to the bleach solution.

    Product
    Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0001-2020·2019-10-09

    Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk

    The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2020·2019-10-09

    Implant Direct RePlant Dental Implants Recalled for Incorrect Packaging

    Implant Direct Sybron Manufacturing is recalling 158 dental implants because the incorrect device was packaged in the vial.

    Product
    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0018-2020·2019-10-09

    Implant Direct Sybron Recalls Mislabeled Dental Implant Vials

    Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.

    Product
    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2020·2019-10-09

    Inter-Med Recalls Chlor-XTRA Dental Syringes Due to Bung Degradation

    Inter-Med LLC is recalling Chlor-XTRA prefilled syringes because the bung may degrade from chemical interaction with the bleach solution.

    Product
    Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0014-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.

    Product
    Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0027-2020·2019-10-09

    Merit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling

    Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0011-2020·2019-10-09

    Scenic Fruit Recalls Frozen Organic Blueberries Due to Foreign Material Contamination

    Scenic Fruit Company is recalling Kirkland Signature frozen organic blueberries due to contamination with foreign materials. The product was distributed in California.

    Product
    Frozen Organic Blueberries Packed into Poly Bag, Net Weight 3 lbs. Product of USA. Item 815544, Kirkland Signature brand. UPC 0 96619 08155 4. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124-1535 USA.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0100-2020·2019-10-09

    Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns

    KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.

    Product
    Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 582 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.

    Product
    Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0026-2020·2019-10-09

    Merit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error

    Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2763-2019·2019-10-09

    Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination

    Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.

    Product
    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2020·2019-10-09

    Alkermes Recalls Vivitrol Kits Due to Needle Labeling Error

    Alkermes is recalling 16,231 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not affected.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0012-2020·2019-10-09

    Espinaler Razor Clams Recalled Due to Unknown Object in Tin

    YTM, Inc. is recalling Espinaler Razor Clams because an unknown object was found in a tin. Consumers should check their pantries for the specific lot code.

    Product
    Espinaler Razor Clams (Trimmed) 4/6 Classic Line, " N4R-LE7R printed on the tin AND/OR E7R MM/YYYY printed on the box. (EAN CODE 8427230010494), 120 g, Aluminum tin in paper carton, Manufactured by: Ca l Espinaler SL Barcelona, Spain
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0011-2020·2019-10-09

    Vista Dental CanalClean Endodontic Irrigation Kit Recalled for Bung Degradation

    Inter-Med LLC is recalling Vista Dental CanalClean kits because the rubber bung may degrade when exposed to bleach solution.

    Product
    Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0066-2020·2019-10-09

    Labetalol HCl syringes are recalled due to lack of sterility assurance

    The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.

    Product
    Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2764-2019·2019-10-09

    ELITech Viva-ProE Systems Recalled for Software Malfunction

    ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.

    Product
    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2254-2019·2019-10-09

    Frito-Lay Recalls Tostitos Queso Dip Due to Glass Jar Defect

    Frito-Lay is recalling Tostitos Medium Queso Blanco Dip because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.

    Product
    Tostitos Medium Queso Blanco Dip 23 oz. packaged in clear glass jar UPC 28400 66872
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-2253-2019·2019-10-09

    Frito-Lay Recalls Tostitos Salsa Con Queso Due to Glass Jar Defect

    Frito-Lay is recalling 95,412 jars of Tostitos Medium Salsa Con Queso because a defect in the glass jar packaging could affect the vacuum seal and cause potential spoilage.

    Product
    Tostitos Medium Salsa Con Queso 23 oz. packaged in a clear glass jar UPC 2840006740
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-2255-2019·2019-10-09

    Frito-Lay Recalls Tostitos Salsa Due to Glass Jar Packaging Defect

    Frito-Lay is recalling Tostitos Medium Chunky Salsa in glass jars because a packaging defect may affect the vacuum seal and cause spoilage.

    Product
    Tostitos Medium Chunky Salsa 24 oz. packaged in clear glass jar UPC 28400 03282
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-0029-2020·2019-10-09

    CooperSurgical Embryology Heated Plate Recall Due to Touchpad Malfunction

    CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.

    Product
    Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V715000·2019-10-08

    Mercedes-Benz Recalls Metris Vans Due to Exposed Battery Fire Risk

    Daimler Vans USA is recalling 2016-2019 Mercedes-Benz Metris vehicles because the backup battery compartment may lack a cover, creating a fire hazard if conductive material contacts the terminals.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V716000·2019-10-08

    2019 Mercedes-Benz and Freightliner Sprinter Door Component Recall

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because an incorrectly installed door component may make doors harder to open after a severe frontal crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 2500, SPRINTER 4500, SPRINTER 3500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20007·2019-10-08

    Ronson Tech Torch Auto Start Recalled by Zippo Due to Fire Hazard

    Zippo is recalling Ronson Tech Torch Auto Start lighters because they may continue to produce a flame after being turned off, posing a fire hazard.

    Product
    Ronson Tech Torch Auto Start
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20008·2019-10-08

    IKEA Recalls MATVRÅ Infant Bibs Due to Choking Hazard

    IKEA is recalling MATVRÅ infant bibs because the neck snaps can detach, posing a choking hazard to young children. No injuries have been reported.

    Product
    MATVRÅ Infant Bibs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V714000·2019-10-08

    Thor Motor Coach Recalls Motorhomes with Incorrect Capacity Labels

    Thor Motor Coach is recalling specific 2014-2020 motorhome models because incorrect carrying capacity labels may allow vehicles to be overloaded, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH CITATION, SIESTA, QUANTUM, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V711000·2019-10-07

    Freightliner Recalls 2018-2020 Cascadia Trucks for ABS Warning Light Defect

    Daimler Trucks North America is recalling 2018-2020 Freightliner Cascadia trucks because the ABS warning light may fail to illuminate during low-voltage starts, potentially leaving drivers unaware of a malfunction.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V707000·2019-10-04

    Blue Bird Recalls School Buses Due to Insufficient Roof Rivets

    Blue Bird is recalling 2019-2021 school buses because insufficient roof rivets may allow roof sheets to separate in a crash, increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN SCHOOL BUS, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V708000·2019-10-04

    Outdoors RV Recalls Trail Series Trailers Due to Axle Mounting Defect

    Outdoors RV is recalling 2019-2020 Trail Series MTN TRX 22TRX toyhauler travel trailers because incorrectly mounted axles may cause unsafe towing conditions.

    Product
    OUTDOORS RV — OUTDOORS RV TRAIL SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20006·2019-10-04

    Harbor Freight Recalls Gordon Folding Knives Due to Laceration Hazard

    Harbor Freight Tools is recalling Gordon folding knives because the locking mechanism can fail, posing a laceration hazard. About 1.1 million units were sold nationwide.

    Product
    Gordon Folding Knives
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20005·2019-10-04

    SPRI Ultra Heavy Resistance Bands Recalled for Injury Hazard

    Fit for Life is recalling SPRI Ultra Heavy Resistance Bands because they can separate from handles and strike users, causing injuries.

    Product
    SPRI Ultra Heavy Resistance Bands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V712000·2019-10-04

    Thomas Built Buses Recall 2014-2020 Models for Seat Impact Absorption Defect

    Daimler Trucks North America is recalling 2014-2020 Thomas Built school buses because specific seats may lack sufficient impact absorption, increasing injury risk in crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V709000·2019-10-04

    Mercedes-Benz Recalls 2020 GLE and GLS Models for Detaching Window Trim

    Mercedes-Benz is recalling 13,799 2020 GLE and GLS vehicles because rear door window trim may detach, creating a road hazard that increases crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC, GLE 350, GLE 450, GLS450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V699000·2019-10-03

    Starcraft RV Recalls Travel Trailers Due to Unprotected Electrical Circuit

    Starcraft RV is recalling certain 2018-2019 travel trailers because fuse wiring may bypass the 30-amp fuse, increasing fire risk during electrical shorts.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT, STARCRAFT, STARCRAFT BUS SATELLITE, MOSSY OAK, MOSSY OAK LITE, COMET MINI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V704000·2019-10-03

    GM Recalls 2020 Chevrolet Equinox for Rear Brake Caliper Defect

    General Motors is recalling 2020 Chevrolet Equinox vehicles because incorrect lubricant in rear brake calipers may cause brake drag and overheating.

    Product
    CHEVROLET — CHEVROLET EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V700000·2019-10-03

    Jayco Eagle Recreational Trailers Recalled for Carbon Monoxide Risk

    Jayco is recalling 2019 Eagle HT and Eagle recreational trailers because the gas range does not vent outside, creating a carbon monoxide hazard.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20002·2019-10-03

    INK+IVY Renu Dressers Recalled for Tip-Over and Entrapment Hazards

    E&E is recalling INK+IVY Renu three-drawer dressers because they are unstable if not anchored, posing tip-over and entrapment risks to children.

    Product
    INK+IVY Renu three-drawer dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E065000·2019-10-03

    SynTec Recalls School Bus Seats for Insufficient Impact Absorption

    SynTec Seating Solutions is recalling S3B and S3C Base Convertible school bus seats because they may lack sufficient impact absorption, increasing injury risk in crashes.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V703000·2019-10-03

    Honda Recalls 2019 CRF450L Motorcycles Due to Horn Mount Defect

    Honda is recalling 2019 CRF450L motorcycles because the horn mount may break, allowing the horn to detach and interfere with handling or become a road hazard.

    Product
    HONDA — HONDA CRF450L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E066000·2019-10-03

    GM Recalls Rugged Liner Tonneau Covers for Installation Defect

    General Motors is recalling Rugged Liner tri-fold soft tonneau covers for 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because difficult instructions may lead to incorrect installation.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20004·2019-10-03

    VIQUA Recalls Solenoid Valve Kits for UV Water Treatment Systems

    VIQUA is recalling solenoid valve kits for UV water treatment systems because electrical current could leak, posing a shock hazard. No injuries have been reported.

    Product
    VIQUA Solenoid Valve Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V702000·2019-10-03

    Jayco Recalls 2017 Pinnacle Fifth Wheel Trailers Due to Suspension Defect

    Jayco is recalling 2017 Pinnacle Fifth Wheel trailers because the suspension may allow tires to contact the structure, causing damage and increasing crash risk.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL PINNACLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V706000·2019-10-03

    Jayco Recalls 2016-2017 Alante Motorhomes Due to Fire Risk

    Jayco is recalling 2016-2017 Alante motorhomes because a missing heat shield may expose hydraulic lines to excessive heat, increasing the risk of a fire.

    Product
    JAYCO — JAYCO ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0125-2020·2019-10-02

    FDA Recalls Quinacrine Dihydrochloride Bulk API Due to Labeling Error

    Darmerica, LLC is recalling 1.8 kilograms of bulk Quinacrine Dihydrochloride API because testing revealed the product was actually Artemisinin.

    Product
    Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2249-2019·2019-10-02

    Whole Foods Recalls Red Apple Cookies Due to Undeclared Egg

    Whole Foods Market is recalling 4,880 decorated red apple cookies because they contain undeclared egg. The cookies were sold in Arizona, Southern California, Hawaii, and southern Nevada.

    Product
    Decorated Red Apple Cookies sold in display case in retail stores
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0036-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0038-2020·2019-10-02

    Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19V698000·2019-10-02

    BMW Recalls 2000-2002 Models for Driver Air Bag Inflator Defect

    BMW is recalling 2000-2002 323, 325, and 330 models because the driver-side air bag inflator may explode, posing a risk of serious injury or death.

    Product
    BMW — BMW 330, 325, 323
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0009-2020·2019-10-02

    FuPaiYuan Matcha Candies Recalled for Undeclared Egg and Milk Allergens

    Rong Shing Trading NY Inc is recalling FuPaiYuan Matcha candies because they may contain undeclared egg and milk allergens.

    Product
    FuPaiYuan Matcha candies "***Candy***NET WT 420G(14.8oz)***INGREDIENTS Glucose syrup, sugar, peanut, Matcha powder, shortening, salt, food additives (Gelatin, vanillin)***Allergies: Contains peanuts***RONG SHING TRADING NY INC***47-57 BRIDGEWATER STREET BROOKLYN NY 11222***BEST B
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0035-2020·2019-10-02

    Natpara Injection Recall Due to Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-2245-2019·2019-10-02

    Alfa International Seafood Recalls Yellowfin Tuna Loins Due to Scombroid Poisoning

    Alfa International Seafood Inc. is recalling 8,585.99 pounds of Yellowfin Tuna Loins after consumers reported symptoms of scombroid poisoning.

    Product
    Alfa International Seafood Miami, Fl, 8402, Yellowfin Tuna Loins, Previously Frozen, Wild Caught, Product of Vietnam
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·19V696000·2019-10-02

    Lamborghini Recalls 2017-2019 Aventador S Models Due to Engine Stall Risk

    Lamborghini is recalling 441 Aventador S vehicles because engine software may cause the engine to stall when coasting to a stop, increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR S ROADSTER, AVENTADOR S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1881-2019·2019-10-02

    Johnson Matthey Recalls Cisplatin Active Pharmaceutical Ingredient Due to Glass Contamination

    Johnson Matthey Inc. is recalling 26,625 grams of Cisplatin Active Pharmaceutical Ingredient due to potential glass contamination.

    Product
    Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2561-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy plans.

    Product
    Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V697000·2019-10-02

    BMW Recalls 2020 S1000 RR Motorcycles Due to Oil Cooler Hose Defect

    BMW is recalling 416 2020 S1000 RR motorcycles because oil cooler hoses may not be attached properly, potentially causing an oil leak that increases crash risk.

    Product
    BMW — BMW S1000 RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V693000·2019-10-02

    Mercedes-Benz Recalls 2018-2019 Sprinter and Metris Vans for Safety Inspection

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz Sprinter and Metris vans because they left the reassembly plant without final quality inspection of safety-relevant parts.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS, SPRINTER 3500, SPRINTER 4500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2247-2019·2019-10-02

    H-E-B Strawberry Ice Cream Recalled for Potential Metal Shavings

    H-E-B is recalling 404 units of Select Ingredients Creamy Creations Strawberry Ice Cream in Texas due to potential metal shavings.

    Product
    H-E-B Select Ingredients Creamy Creations Strawberry Ice Cream 1/2 gallon UPC 4122034602 packaged in paper carton with lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0008-2020·2019-10-02

    FuPaiYuan Nougat Candies Recalled for Undeclared Egg and Milk Allergens

    Rong Shing Trading NY Inc is recalling FuPaiYuan Nougat Candies because they may contain undeclared egg and milk allergens.

    Product
    FuPaiYuan "***NOUGAT CANDIES***20190424***Candy***NET WT 450G (15.8oz)***INGREDIENTS Glucose syrup, sugar, peanut, shortening, salt, food additives (Gelatin)***Allergies: Contains peanuts***RONG SHING TRADING NY INC***47-57 BRIDGEWATER STREET BROOKLYN NY, 11222***BEST BEFORE: 01.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2489-2019·2019-10-02

    B.Braun Infusion Pump Administration Set Recalled for Potential Leaks

    B. Braun Medical is recalling 2,580 Infusomat Space Volumetric Infusion Pump Administration Sets due to a risk of leaking or disconnecting at the Y-site joint.

    Product
    B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·19V695000·2019-10-02

    Daimler Recalls 2018-2019 Sprinter Vehicles for Inactive Airbag Systems

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz and Freightliner Sprinter vans because their airbag systems may not have been activated, increasing crash injury risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 4500, SPRINTER 1500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2019·2019-10-02

    Sentinel CH SpA Recalls Alinity c Lithium Reagent Kits

    Sentinel CH SpA is recalling Alinity c Lithium Reagent Kits due to a potential carryover issue that may result in falsely elevated lithium patient results.

    Product
    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2019·2019-10-02

    Medline Electric Surgical Clipper Recalled for Overheating Charger Base

    Medline Industries is recalling 500 electric surgical clippers because a defective circuit board component may cause the charger base to overheat and malfunction.

    Product
    MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0034-2020·2019-10-02

    Star Fisheries Recalls Fresh Irish Salmon Fillets for Listeria Risk

    Star Fisheries, Inc. is recalling fresh Irish salmon fillets due to potential Listeria monocytogenes contamination. The product was distributed to retail stores in California.

    Product
    Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh Irish Salmon Fillet Ireland Farmed. Random weight boxes fillets cut and distributed. Keep Refrigerated, Color Added. Packed by Star Fisheries Inc., Wilmington, CA
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2753-2019·2019-10-02

    Accu-Chek Connect App Recall for Android Data Transfer Failure

    Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2556-2019·2019-10-02

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Banner Card

    Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.

    Product
    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2250-2019·2019-10-02

    Udi's Classic Hamburger Buns Recalled for Potential Foreign Material

    ConAgra Foods is recalling Udi's Classic Hamburger Buns due to the potential presence of foreign material. The product was distributed to wholesale and retail locations in 13 states.

    Product
    Udi's Classic Hamburger Buns, packaged in a 10.4 oz. plastic bag, with eight bags per wholesale case. UPC 00-6-98997-80913-5 .
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1878-2019·2019-10-02

    Akorn Recalls Lidocaine Hydrochloride Jelly Due to Metal Particulate Finding

    Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2% due to a finding of metal particulate matter in the filling room. No particulates were identified in the product itself.

    Product
    Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2019·2019-10-02

    Getinge Recalls One Vascular Graft Due to Incorrect Packaging Label

    Getinge is recalling one HEMASHIELD GOLD vascular graft that was incorrectly packed in a carton labeled for a HEMASHIELD PLATINUM graft.

    Product
    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the op
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2248-2019·2019-10-02

    UNFI Recalls Apetina Marinated Olives and Feta Due to Temperature Violation

    UNFI General Corporate is recalling Apetina Marinated Olives & Feta in Olive Oil because the product was held at room temperature despite requiring refrigeration.

    Product
    Apetina Marinated Olives & Feta in Olive Oil, packed in 3.1 LB pals; 4 pals/case; UPC: 0009393605697
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1882-2019·2019-10-02

    FDA Recalls Oxaliplatin Active Pharmaceutical Ingredient Due to Glass Contamination

    Johnson Matthey Inc. is recalling Oxaliplatin Active Pharmaceutical Ingredient due to potential glass contamination. The product was distributed nationwide in the United States.

    Product
    Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2553-2019·2019-10-02

    GN Otometrics Recalls Gold Cup and Snap Leadwires Due to Conductor Defect

    GN Otometrics is recalling Gold Cup and Snap Leadwires because the electrode lead connector has a protruding conductor beyond the insulation.

    Product
    Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2019·2019-10-02

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Recall for Wireless Connectivity Issues

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps with PharmGuard Server Software due to potential wireless network connectivity issues caused by a Radio Module defect.

    Product
    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2754-2019·2019-10-02

    Siemens Recalls Atellica IM Anti-CCP IgG Assay Due to Mitigation Failure

    Siemens Healthcare Diagnostics is recalling 169 kits of the Atellica IM anti-CCP IgG assay because a reagent carryover mitigation step fails to complete on the analyzer.

    Product
    Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2019·2019-10-02

    V-Twin Automated Chemistry Analyzer Recalled for Software Lockup

    Vital Scientific N.V. is recalling two V-Twin automated chemistry analyzers in New York because a software lockup prevents the instruments from producing patient results.

    Product
    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2755-2019·2019-10-02

    Abbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label

    Abbott is recalling 159 APS Accelerator modular systems because the safety pacemaker label is missing. The Operations Manual has been updated to specify a 200 mm minimum safety distance for pacemaker wearers.

    Product
    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-2551-2019·2019-10-02

    Sentinel CH SpA Recalls MULTIGENT Lithium Reagent Kits

    Sentinel CH SpA is recalling 15,919 MULTIGENT Lithium reagent kits due to a potential carryover issue that may cause falsely elevated patient results.

    Product
    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2244-2019·2019-10-02

    Silk Soymilk Vanilla Recalled for Misleading Outer Box Labeling

    Danone is recalling Silk Soymilk Vanilla Bag-In-Box because the outer box incorrectly identifies the product as almond milk. The internal product is correctly labeled as soymilk.

    Product
    Silk Soymilk Vanilla Bag-In-Box. One, 2.5 gallon bag per box. 2.5 gal Bag-In-Box to be used in a dispensing machine at foodservice & convenience outlets.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1880-2019·2019-10-02

    Fentanyl Citrate Ingredient Recalled for Potential Glass Contamination

    Johnson Matthey Inc. is recalling fentanyl citrate active pharmaceutical ingredient due to potential glass contamination.

    Product
    Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1877-2019·2019-10-02

    Preferred Pharmaceuticals Recalls Fexofenadine HCl Tablets Due to Impurities

    Preferred Pharmaceuticals is recalling 79 bottles of Fexofenadine HCl 180 mg tablets because they failed impurities and degradation specifications.

    Product
    Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0120-2020·2019-10-02

    EPI Health Recalls Minolira Tablets for Dissolution Failures

    EPI Health is recalling 1,626 bottles of Minolira extended-release tablets because they failed dissolution specifications. The recall is limited to EPI field representatives.

    Product
    minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI
    Category
    Drug
    Distribution
    0 states

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