The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
214
High
393
Moderate
191
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

101–200 of 863

  • HighFDA (Devices)·Z-2859-2018·2018-08-29

    Philips DigitalDiagnost Dual Detector Footplate Recall for Injury Risk

    Philips is recalling DigitalDiagnost Dual Detector units because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2854-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Flex Footplate Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4.1 Flex and Value units because the footplate hook may fail, causing the footplate to fall and injure patients or operators.

    Product
    DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2850-2018·2018-08-29

    Philips DigitalDiagnost 4 Flex Footplate Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4 Flex and Value units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2018·2018-08-29

    Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost Single-Detect units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2864-2018·2018-08-29

    Philips DigitalDiagnost Upgrades Recalled Due to Footplate Safety Hazard

    Philips is recalling DigitalDiagnost Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Upgrades (Stitching Patient Support) 712083
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2865-2018·2018-08-29

    Philips DigitalDiagnost Dual-Detector Recall for Footplate Safety Hazard

    Philips is recalling DigitalDiagnost Dual-Detector units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2018·2018-08-29

    bioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues

    bioMerieux is recalling VITEK 2 Gram Positive Test Kits because customer reports indicated an increased rate of non-detected MRSA.

    Product
    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2853-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Chest X-Ray Unit Recalled for Footplate Hazard

    Philips is recalling DigitalDiagnost 4.1 Chest X-Ray units because a defective hook allows the footplate to fall, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2887-2018·2018-08-29

    CAREstream ProNox Nitrous Oxide Delivery Systems Recalled for High Gas Levels

    CAREstream Medical LLC is recalling 919 ProNox Nitrous Oxide Delivery Systems because two units delivered higher levels of nitrous oxide than specified during routine testing.

    Product
    CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System wit
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2855-2018·2018-08-29

    Philips DigitalDiagnost 4.1 High Performance Footplate Recall Issued

    Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2840-2018·2018-08-29

    Elekta Digital Accelerator Recall for Potential Uncontrolled Detector Arm Extension

    Elekta is recalling 2,998 Digital Accelerators worldwide due to a potential for uncontrolled extension of iViewGT or XVI detector arms.

    Product
    ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2018·2018-08-29

    Philips DigitalDiagnost Single Detector Footplate Hook Recall

    Philips is recalling DigitalDiagnost Single Detector units because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Single Detector (Stitching Patient Support) 712020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1848-2018·2018-08-29

    Reser's Stonemill Kitchens Three Cheese Pasta Spinache Recalled for Cyclospora

    Reser's Fine Foods is recalling Three Cheese Pasta Spinache Stonemill Kitchens due to potential Cyclospora contamination in the spinach ingredient.

    Product
    Three Cheese Pasta Spinache Stonemill Kitchens, item # 71117.19500, 2/5 # packages. UPC 0 71117 19500 2. Product is pasta salads with vinaigrette dressings and vegetables including spinach. All products are in white plastic tubs with labeled lids packed 2/5 # to a corrugate
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2889-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error

    Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2886-2018·2018-08-29

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International is recalling 166 kits of pediatric central venous catheters because the packaging incorrectly identifies the catheter length.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is i
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2880-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2888-2018·2018-08-29

    Civco Infiniti Needle Guide Bracket Recalled for Leak Testing Failure

    Civco Medical Instruments is recalling Infiniti Needle Guide Brackets because a cover failed leak testing during validation of new needle guides.

    Product
    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2879-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1842-2018·2018-08-29

    Tropical Pepper Co. Crushed Chili Pepper Sauce Recalled for Labeling Error

    Alimentos Kamuk Internacional is recalling Tropical Pepper Co. Crushed Chili Pepper Sauce because the sodium values on the label are inconsistent with the current value.

    Product
    TROPICAL PEPPER CO. Crushed Chili Pepper Sauce, 11.5 FL. OZ. (325ml), PRODUCT OF COSTA RICA, Packed Exclusively for: H.L. Benndorf Corp. Medford, NJ 08055
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2890-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug

    Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.

    Product
    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2018·2018-08-29

    Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower

    Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.

    Product
    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2881-2018·2018-08-29

    Back 2 Basics Recalls Dymaxeon 5.5 Curved Spinal Rods Due to Labeling Error

    Back 2 Basics Direct LLC is recalling 10 Dymaxeon 5.5 Curved Rods because packages labeled as 110mm may contain 100mm rods.

    Product
    Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1843-2018·2018-08-29

    Asian Gourmet Spicy Chili & Garlic Sauce Recalled for Labeling Error

    Asian Gourmet Spicy Chili & Garlic Sauce is being recalled because the sodium values on the label are not consistent with the current value.

    Product
    ASIAN GOURMET SPICY Chili & Garlic Sauce, NET WT. 12.3 OZ (380g), Distributed by Asian Gourmet 313 Iron Horse Way, Providence, RI 02908 USA, Product of Costa Rica
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2882-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error

    Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.

    Product
    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Errors

    Ortho Kinematics is recalling VMA software versions 2.3.239 through 2.3.254 because administrative errors caused incorrect data in radiological and VMA reports.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2018·2018-08-29

    Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance

    Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.

    Product
    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2921-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibod
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1112-2018·2018-08-29

    Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1958-2018·2018-08-29

    Gourmet International Recalls LItaly Sparkling Sour Cherry Juice Drink

    Gourmet International Inc. is voluntarily recalling LItaly Sparkling Sour Cherry Juice Drink due to packaging concerns and reports of leaking caps.

    Product
    SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottles
    Category
    Food
    Distribution
    8 states
  • LowFDA (Devices)·Z-2922-2018·2018-08-29

    Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.

    Product
    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2920-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoanti
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2919-2018·2018-08-29

    Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling

    Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases,
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·18E087000·2018-08-28

    Dexter D44 Trailer Axles Recalled for Potential Bearing Failure

    Dexter Axle is recalling D44 trailer axles with 4,400-pound capacity because missing inner bearing races can cause hub overheating or bearing failure.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V567000·2018-08-28

    MAC Trailers Recalls 2019 Dump and Waste Trailers for Wheel Nut Defect

    MAC Trailer Mfg. is recalling 2019 Dump and Waste trailers because the wheel end nut locking device may not be properly installed, allowing the wheel end to separate from the axle.

    Product
    MAC TRAILERS — MAC TRAILERS WASTE TRAILER, DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V566000·2018-08-28

    Blue Bird Recalls School Buses for Missing Child Restraint Warning Labels

    Blue Bird is recalling 2019-2020 Vision and All American school buses because certain child restraint seats may be missing a required warning label on the lower strap.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V564000·2018-08-27

    Jayco Recalls 2015-2017 Redhawk Motorhomes Due to Fire Risk

    Jayco is recalling 2015-2017 Redhawk motorhomes because liquid leakage into the driver's power window switch can cause corrosion and increase the risk of a fire.

    Product
    JAYCO — JAYCO REDHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V565000·2018-08-27

    Fabform Recalls 2018 EPT Dump Trailers Due to Hinge Fracture Risk

    Fabform is recalling 2018 EPT dump trailers because welded hinges may fracture, causing the dump box to fall unexpectedly and increasing the risk of injury or death.

    Product
    FABFORM — FABFORM DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18762·2018-08-27

    Polaris Recalls 2018 RZR XP Turbo S Vehicles Due to ROPS Fracture Hazard

    Polaris is recalling about 1,300 model year 2018 RZR XP Turbo S recreational off-highway vehicles because the rollover protection structure can fracture during high-speed rollovers.

    Product
    Model year 2018 RZR XP Turbo S recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·PHA-08242018-01·2018-08-24

    USDA Issues Public Health Alert for Empire Kosher Raw Chicken Due to Salmonella

    USDA FSIS issued a public health alert for Empire Kosher raw chicken products sold from September 2017 to June 2018 due to a link with a Salmonella outbreak.

    Product
    FSIS Issues Public Health Alert for Empire Kosher Poultry, Inc. Raw Chicken Products due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V563000·2018-08-24

    Navistar Recalls 2015-2019 IC Bus School Buses Due to Wheelchair Lift Defect

    Navistar is recalling 2015-2019 IC Bus school buses equipped with specific wheelchair lifts because a component may fail, allowing the platform to rise too high and increasing injury risk.

    Product
    IC BUS — IC BUS CESB, CASB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·069-2018·2018-08-23

    Cargill Recalls Ground Beef Due to Possible E. coli O157:H7 Contamination

    Cargill Meat Solutions is recalling approximately 25,288 pounds of ground beef products that may be contaminated with E. coli O157:H7. The products were shipped to warehouses in California and Colorado.

    Product
    Cargill Meat Solutions — Cargill Meat Solutions Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V559000·2018-08-23

    REV Recalls 2018-2019 Motorhomes Due to Generator Exhaust Fire Risk

    REV Recreation Group is recalling 2018-2019 Fleetwood Pulse and Holiday Rambler Prodigy motorhomes because the generator exhaust pipe may contact the waste tank, increasing fire risk.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD PRODIGY, PULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V561000·2018-08-23

    Thomas Built Buses Saf-T-Liner C2 School Bus Seat Recall

    Daimler Trucks North America is recalling 2017-2019 Thomas Built Buses Saf-T-Liner C2 school buses because seat mounting feet may pull through the floor joint in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V556000·2018-08-23

    RAM 1500 Recall for Rear Differential Oil Level Defect

    Chrysler is recalling 2018-2019 RAM 1500 trucks because the rear differential may be underfilled, which could cause axle failure and increase crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V560000·2018-08-23

    Thomas Built Buses Recalling Wheelchair Lifts Due to Cam Failure

    Daimler Trucks is recalling 2015-2019 Thomas Built Buses equipped with specific wheelchair lifts because a component may fail, allowing the platform to rise too high.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·18199·2018-08-22

    Vornado VH101 Electric Space Heaters Recalled Due to Fire and Death

    Vornado Air is recalling VH101 Personal Vortex electric space heaters because they can overheat, posing fire and burn hazards. One death and 19 fire reports have been linked to the units.

    Product
    VH101 Personal Vortex electric space heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1828-2018·2018-08-22

    MBG Marketing Recalls Naturipe Blueberries Due to Salmonella Contamination

    MBG Marketing is recalling 1,320 boxes of Naturipe Blueberries because the product tested positive for Salmonella. The affected product was distributed to New York.

    Product
    naturipe Blueberries, INDIVIDUAL QUICK FROZEN, NET WT 30-LBS cardboard boxes, DISTRIBUTED BY NATURIPE 04726 COUNTY ROAD 215, GRAND JUNCTION, MN 43058
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1095-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling specific lots of Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1098-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 320mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling 14 bottles of Valsartan 320mg tablets distributed in Indiana because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1083-2018·2018-08-22

    Ranier's Triple P Injection Recalled for Sterility Assurance Concerns

    Ranier's Compounding Laboratory is recalling Triple P Injection due to practices that may call into question the sterility of the product.

    Product
    Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1084-2018·2018-08-22

    Ranier's PR/PA/PH Injection Recalled for Sterility Concerns

    Ranier's Compounding Laboratory is recalling PR/PA/PH Injection vials due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1085-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Morphine Sulf Inhalation Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling 60 vials of Morphine Sulf inhalation because practices at the firm may call into question the sterility of the product.

    Product
    Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1092-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Prostaglandin Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Pro/PA/PH/AT Injection in Pennsylvania due to a lack of assurance of sterility.

    Product
    PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2793-2018·2018-08-22

    NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

    NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

    Product
    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1097-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 80mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling Valsartan 80mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1077-2018·2018-08-22

    Lupin Recalls Lisinopril Tablets Due to Metal Contaminant

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril tablets because a metal contaminant was found in one tablet.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-1101-2018·2018-08-22

    RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1093-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls P/P/P Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the product.

    Product
    P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1088-2018·2018-08-22

    Ranier's Medroxprogesterone Ophthalmic Solution Recalled for Sterility Concerns

    Ranier's Compounding Laboratory is recalling Medroxprogesterone 1% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1078-2018·2018-08-22

    alba BOTANICA Sunscreen Recalled for Microbial Contamination

    The Hain Celestial Group is recalling alba BOTANICA Sensitive Sheer Shield Sunscreen SPF 50+ due to microbial contamination. Consumers should stop using the product.

    Product
    alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1096-2018·2018-08-22

    Northwind Recalls Valsartan HCTZ Tablets Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling 43 bottles of Valsartan HCTZ 160/12.5mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1094-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Papav 300/Phent 5mg/10mL Injection due to lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1086-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Dehydrated Alcohol Solution Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution vials because practices at the firm may call into question the sterility of the products.

    Product
    Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1090-2018·2018-08-22

    Ranier's P/P/P Injection Recalled for Sterility Assurance Concerns

    Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the products.

    Product
    P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V554000·2018-08-22

    Volvo Recalls 2019 XC40 Vehicles Due to Brake Pedal Rivet Defect

    Volvo is recalling 2019 XC40 vehicles because brake pedals may not be correctly riveted, potentially reducing braking performance and increasing crash risk.

    Product
    VOLVO — VOLVO XC40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1087-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Vitamin D3 Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL, 4 mL vials, because practices at the firm may call into question the sterility of the product.

    Product
    Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1080-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Atropine 0.01% Opth Solution

    Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.

    Product
    Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating roo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1081-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls DMSO 6.25% Opth Sol for Sterility Concerns

    Ranier's Compounding Laboratory is recalling DMSO 6.25% Opth Sol due to a lack of assurance of sterility. The product was distributed within Pennsylvania.

    Product
    DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1089-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls Acetylcysteine 10% Ophthalmic Solution

    Ranier's Compounding Laboratory is recalling Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2018·2018-08-22

    RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1100-2018·2018-08-22

    RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1091-2018·2018-08-22

    Ranier's Compounding Laboratory Recalls PRASH Injection Due to Sterility Concerns

    Ranier's Compounding Laboratory is recalling PRASH Injection vials because practices at the firm may call into question the sterility of the product.

    Product
    PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2808-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states

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