The Recall Desk

Archive

January 2019 recalls

247 recalls were announced in January 2019.

What the numbers show

Critical
18
Severe
91
High
87
Moderate
42
Low
9

Of the 247 recalls this month scored against our rubric, 7% are Critical, 37% are Severe.

101–200 of 247

  • SevereUSDA FSIS·004-2019·2019-01-18

    H & T Seafood Recalls Frozen Siluriformes Fish Products for Import Inspection Failure

    H & T Seafood, Inc. is recalling approximately 71,435 pounds of frozen Siluriformes fish products because they were not presented for import re-inspection upon entry into the United States.

    Product
    H & T Seafood, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·19V043000·2019-01-18

    Heartland Recalls 2019 Trailers Due to Incorrect Tire Certification Labels

    Heartland is recalling 2019 Prowler and Trail Runner trailers because their Federal Certification Labels may list incorrect tire size, load range, and pressure information.

    Product
    HEARTLAND — HEARTLAND TRAIL RUNNER, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V039000·2019-01-17

    Jaguar Recalls 2019 F-Pace, F-Type, and XJ for Crankshaft Bolt Defect

    Jaguar is recalling 2019 F-Pace, F-Type, and XJ vehicles because a defective crankshaft pulley bolt may fracture, causing engine failure and increasing crash risk.

    Product
    JAGUAR — JAGUAR F-PACE, F-TYPE, XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V040000·2019-01-17

    Land Rover Recalls 2019 Models for Crankshaft Bolt Fracture Risk

    Jaguar Land Rover is recalling 2019 Range Rover and Discovery models because a crankshaft pulley bolt may fracture, causing engine failure and increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER VELAR, RANGE ROVER, RANGE ROVER SPORT, DISCOVERY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2019·2019-01-17

    Perdue Recalls Gluten-Free Chicken Nuggets Due to Wood Contamination

    Perdue Foods is recalling approximately 68,244 pounds of SimplySmart Organics Gluten Free Chicken Nuggets due to possible wood contamination. Consumers should discard or return the product.

    Product
    Perdue Foods LLC — Perdue Foods LLC Recalls Simplysmart Organics Gluten Free Chicken Nugget Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0358-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.

    Product
    Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0372-2019·2019-01-16

    Sun Pharmaceutical Recalls Vecuronium Bromide Due to Glass Particulates

    Sun Pharmaceutical Industries is recalling Vecuronium Bromide for Injection because glass particles were detected in the product.

    Product
    VECURONIUM BROMIDE — VECURONIUM BROMIDE (VECURONIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0765-2019·2019-01-16

    Adam Bros. Family Farms Cauliflower Recalled for E. coli O157:H7 Contamination

    Adam Bros. Farming, Inc. is recalling specific cases of Adam Bros. Family Farms Cauliflower due to potential E. coli O157:H7 contamination. The product was distributed in 10 states.

    Product
    Adam Bros. Family Farms Cauliflower; Sold in cases with 9, 12, 16 or 20 count cases
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·19V019000·2019-01-16

    GM Recalls 2010-2011 Chevrolet Malibu for Air Bag Inflator Defect

    General Motors is recalling 2010-2011 Chevrolet Malibu vehicles because the driver's air bag inflator may explode during a crash, potentially causing serious injury or death.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250 mg, due to the presence of grey rubber particulate matter from stoppers in reconstituted vials.

    Product
    Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, due to the presence of grey rubber particulate matter from stoppers.

    Product
    Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2019·2019-01-16

    Heritage Pharmaceuticals Recalls Cidofovir Injection Due to Sterility Concerns

    Heritage Pharmaceuticals is recalling Cidofovir Injection vials due to complaints about dried powder on the outside of the bottles, which raises concerns about sterility.

    Product
    Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V035000·2019-01-16

    Audi Recalls A8, A7, A6, and Q7 Models for Fuel Rail Leaks

    Audi is recalling specific 2015-2018 models because fuel rails may leak, increasing the risk of fire if an ignition source is present.

    Product
    AUDI — AUDI A8, A7, A6, Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP vials because grey rubber flecks were found in the reconstituted product.

    Product
    Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Li
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2019·2019-01-16

    Baxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns

    Baxter Healthcare is recalling 29,370 bags of Dianeal Low Calcium peritoneal dialysis solution because confirmed customer complaints identified leaks in the tubing, compromising sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0697-2019·2019-01-16

    Swissray Medical Recalls ddRCombi Plus FP X-ray Systems Due to Lifting Column Defect

    Swissray Medical AG is recalling three ddRCombi Plus FP X-ray systems because a lifting column component may break, causing the arm to drop and potentially seriously injure patients or users.

    Product
    ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0763-2019·2019-01-16

    Adam Bros. Red Leaf Lettuce Recalled for E. coli O157:H7 Risk

    Adam Bros. Farming, Inc. is recalling Red Leaf Lettuce due to potential E. coli O157:H7 contamination. The product was distributed in 11 states.

    Product
    Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carton Adams Bros Family Farms and Ovation
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0764-2019·2019-01-16

    Adam Bros. Green Leaf Lettuce Recalled for E. coli O157:H7 Risk

    Adam Bros. Farming is recalling Green Leaf Lettuce due to potential E. coli O157:H7 contamination. The product was distributed in 11 states.

    Product
    Adam Bros. Family Farms Green Leaf Lettuce; 24 heads per case
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0692-2019·2019-01-16

    Agfa-Gevaert Recalls DX-D 600 Direct Radiography Systems Due to Movement Defect

    Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.

    Product
    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiograph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2019·2019-01-16

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.

    Product
    Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2019·2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0387-2019·2019-01-16

    Allergan Recalls Ozurdex Dexamethasone Implants Due to Silicone Particulate

    Allergan is recalling 133,716 cartons of Ozurdex (dexamethasone) intravitreal implants because a silicone particulate was detected. The product was distributed to various accounts throughout the United States.

    Product
    OZURDEX — OZURDEX (DEXAMETHASONE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0706-2019·2019-01-16

    Elekta Unity MRI Speakers May Become Dislodged and Enter Bore

    Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.

    Product
    Elekta Unity
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0703-2019·2019-01-16

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Collimator Locking Hazard

    GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.

    Product
    Discover VH/Millennium VG Nuclear Medicine Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0709-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of th
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2019·2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2019·2019-01-16

    Philips Ingenia MRI Systems Recalled for Table Movement Safety Issue

    Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.

    Product
    Ingenia Elition S, Ingenia Elition X
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0374-2019·2019-01-16

    PharMEDium Recalls Subpotent Buffered Lidocaine HCl Syringes Nationwide

    PharMEDium Services is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl because the product was found to be subpotent.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0707-2019·2019-01-16

    Siemens Biograph Horizon PET/CT System Recalled for Design Defects

    Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.

    Product
    Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled for Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0705-2019·2019-01-16

    Mevion Medical Systems Recalls MEVION S250i Medical Device

    Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.

    Product
    MEVION S250i
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0702-2019·2019-01-16

    Cardinal Health Recalls Presource Kit Total Joint Pack Due to Sterility Concerns

    Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.

    Product
    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0376-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0693-2019·2019-01-16

    GE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version

    GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.

    Product
    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0375-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0700-2019·2019-01-16

    Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan

    Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0701-2019·2019-01-16

    Boston Scientific Recalls IntellaNav Ablation Catheters in Japan

    Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0699-2019·2019-01-16

    Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes

    Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.

    Product
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19V018000·2019-01-15

    Chrysler Recalls Vehicles Due to Exploding Passenger Air Bag Inflator Risk

    Chrysler is recalling specific 2010-2016 Dodge, Chrysler, and Jeep vehicles because the passenger air bag inflator may explode during deployment, potentially causing serious injury or death.

    Product
    JEEP — JEEP, CHRYSLER, DODGE WRANGLER, 300, DAKOTA, RAM 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V016000·2019-01-14

    BMW Recalls 2015 X1 Vehicles for Driver Air Bag Inflator Defect

    BMW is recalling 2015 X1 vehicles because the driver's air bag inflator may explode due to humidity, posing a risk of serious injury or death.

    Product
    BMW — BMW X1 SAV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V032000·2019-01-14

    Volvo Recalls 2018-2019 VNL Trucks for Clutch Assembly Defect

    Volvo is recalling 2018-2019 VNL trucks with automated manual transmissions because a clutch component may fail, causing unintended vehicle movement.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V017000·2019-01-14

    BMW Recalls X5 and X6 Models Due to Air Bag Inflator Defect

    BMW is recalling 2007-2014 X5 and X6 models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    BMW — BMW X6, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V015000·2019-01-14

    BMW Recalls 2000-2004 Models for Air Bag Inflator Explosion Risk

    BMW is recalling specific 2000-2004 5 Series and X5 vehicles because the air bag inflator in optional sports steering wheels may explode, posing a serious injury risk.

    Product
    BMW — BMW 540I, 525I, X5 SAV, 530I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V031000·2019-01-14

    Ford Recalls 2019 Lincoln Nautilus for Lane Center Assist Defect

    Ford is recalling 2019 Lincoln Nautilus vehicles because the Lane Center Assist system may fail to detect if the driver's hands are off the steering wheel for a prolonged period.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V014000·2019-01-11

    Volkswagen and Audi Recall Vehicles Due to Airbag Inflator Defect

    Volkswagen is recalling specific 2015-2017 models because the driver's airbag inflator may explode during deployment, potentially causing serious injury.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI CC, TT ROADSTER, EOS, PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V030000·2019-01-11

    Double K Recalls 2017-2019 Hometown Trolley Buses for Brake Bolt Issue

    Double K is recalling 2017-2019 Hometown Trolley buses because brake caliper bolts may loosen, reducing brake effectiveness and increasing crash risk.

    Product
    HOMETOWN TROLLEY — HOMETOWN TROLLEY STREETCAR, VILLAGER, MAINSTREET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V029000·2019-01-11

    Double K Recalls 2017-2018 Hometown Trolley Buses for Brake Bolt Issue

    Double K is recalling 2017-2018 Hometown Trolley buses because loose brake caliper bolts may reduce braking effectiveness and increase crash risk.

    Product
    HOMETOWN TROLLEY — HOMETOWN TROLLEY MAINSTREET, STREETCAR, VILLAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0552-2019·2019-01-09

    Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error

    Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.

    Product
    StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
    Category
    Medical Device
    Distribution
    51 states
  • CriticalNHTSA·19V010000·2019-01-09

    Mercedes-Benz Recalls Vehicles Due to Passenger Air Bag Inflator Defect

    Mercedes-Benz is recalling specific 2010-2017 models because passenger air bag inflators may explode due to humidity, posing a risk of serious injury or death.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ C300, E350, GLK350, C350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·19V008000·2019-01-09

    Subaru Recalls Vehicles Due to Passenger Air Bag Inflator Explosion Risk

    Subaru is recalling specific 2010-2014 models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    SUBARU — SUBARU OUTBACK, FORESTER, LEGACY, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0395-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls HCG Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling HCG liquid vials because they may lack sterility assurance. The product was distributed in Oregon to medical facilities and patients.

    Product
    HCG liquid, 1000u/ml, RX, glass vial, various
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V005000·2019-01-09

    Toyota Recalls Vehicles for Front Passenger Air Bag Inflator Defect

    Toyota is recalling approximately 1.3 million vehicles because front passenger air bag inflators may explode due to humidity, potentially causing serious injury or death.

    Product
    TOYOTA — TOYOTA, LEXUS, SCION COROLLA MATRIX, IS F, COROLLA, 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V006000·2019-01-09

    Ferrari Recalls Multiple Models Due to Passenger Air Bag Inflator Defect

    Ferrari is recalling various models from 2014 to 2018 because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    FERRARI — FERRARI CALIFORNIA T, FF, F12 BERLINETTA, 488 GTB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V007000·2019-01-09

    Subaru Recalls Vehicles Due to Front Passenger Air Bag Inflator Defect

    Subaru is recalling specific 2010-2014 models because front passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    SUBARU — SUBARU OUTBACK, FORESTER, LEGACY, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·001-2019·2019-01-09

    J. H. Routh Packing Recalls Pork Sausage Due to Rubber Contamination

    J. H. Routh Packing Co. is recalling approximately 1,719 pounds of raw pork sausage products that may contain rubber. The products were shipped to retail locations in Kentucky, Ohio, and Pennsylvania.

    Product
    HK Cooperative, Inc. — J. H. Routh Packing Co. Recalls Pork Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·19V009000·2019-01-09

    Subaru Recalls Vehicles Due to Air Bag Inflator Explosion Risk

    Subaru is recalling specific 2010-2014 models because passenger air bag inflators may explode during deployment, potentially causing serious injury or death.

    Product
    SUBARU — SUBARU OUTBACK, FORESTER, LEGACY, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls Lidocaine/Epinephrine Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling Lidocaine/Epinephrine liquid 1%/1:1000 in 50 ml glass vials due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.

    Product
    Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0404-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling compounded Cyclosporin liquid 0.5% in plastic dropper bottles due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities, a physician's office, and patients.

    Product
    Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0687-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.

    Product
    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0346-2019·2019-01-09

    Lupin Recalls Subpotent Nitrofurantoin Oral Suspension Lots

    Lupin Pharmaceuticals is recalling specific lots of Nitrofurantoin Oral Suspension because the drug was found to contain less active ingredient than required.

    Product
    NITROFURANTOIN — NITROFURANTOIN (NITROFURANTOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0691-2019·2019-01-09

    R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card

    R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.

    Product
    Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0690-2019·2019-01-09

    Ultradent Recalls Enamelast Fluoride Varnish Due to Off-Flavor Complaints

    Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.

    Product
    Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V004000·2019-01-08

    Daimler Recalls 2014-2017 Sprinter Vans Due to Air Bag Inflator Defect

    Daimler Vans USA is recalling 2014-2017 Freightliner and Mercedes-Benz Sprinter vans because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V003000·2019-01-08

    Daimler Recalls 2015-2017 Sprinter Vehicles Due to Air Bag Inflator Defect

    Daimler Vans USA is recalling 2015-2017 Freightliner and Mercedes-Benz Sprinter 2500 and 3500 vehicles because driver air bag inflators may explode during deployment.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V026000·2019-01-07

    Keystone Recalls Dutchmen Travel Trailers Due to Tire Clearance Issue

    Keystone RV is recalling 2017-2019 Dutchmen Voltage and 2019 Endurance travel trailers because tires may contact the rear floor support, affecting handling.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE, ENDURANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V027000·2019-01-07

    MCI Coaches Recalled for Hydraulic Steering System Locking Risk

    Motor Coach Industries is recalling specific 1997-2015 coaches because a steering defect may cause loss of control at highway speeds.

    Product
    MCI — MCI 102EL3, E4500, J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V001000·2019-01-07

    Ford Recalls Vehicles for Air Bag Inflator Explosion Risk

    Ford is recalling specific 2010-2014 models because passenger air bag inflators may explode due to humidity, posing a serious injury risk.

    Product
    FORD — FORD, LINCOLN, MERCURY MUSTANG, RANGER, EDGE, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E004000·2019-01-06

    WSB SC101 Motorcycle Helmets Recalled for Impact Protection Failure

    WSB Inc is recalling SC101 half-helmets manufactured in January 2018 because they may not adequately protect the wearer's head during an impact.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V025000·2019-01-04

    Vantage AMS Edge II Recalled for Fuel Leak Fire Risk

    Vantage Mobility International is recalling 2014-2017 AMS Edge II vehicles because a deteriorating fuel pump gasket may cause fuel leaks, increasing fire risk.

    Product
    VANTAGE — VANTAGE AMS EDGE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0819-2019·2019-01-02

    Apio Recalls Eat Smart Salad Shake Ups Due to Listeria Risk

    Apio, Inc. is recalling Eat Smart Salad Shake Ups in Avocado Ranch flavor because the Canadian Food Inspection Agency detected Listeria monocytogenes in the product.

    Product
    Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5.5 oz. (156 g); US UPC: 7 09351-30177 3; Canadian UPC: 7 09351 30195 7; Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
    Category
    Food
    Distribution
    14 states

Looking for a different month? Back to 2019.