The Recall Desk

Archive

April 2021 recalls

449 recalls were announced in April 2021.

What the numbers show

Critical
28
Severe
123
High
196
Moderate
90
Low
12

Of the 449 recalls this month scored against our rubric, 6% are Critical, 27% are Severe.

Which agencies issued them

301–400 of 449

  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2021·2021-04-14

    Terumo Sternal Retractor Locking Mechanism Recall for Fracture Risk

    Terumo is recalling 12 sternal retractor devices because the stainless steel locking plates may fracture. The devices were distributed in eight US states.

    Product
    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1355-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits

    Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0327-2021·2021-04-14

    Cosette Recalls Mometasone Furoate Topical Solution Due to CGMP Deviations

    Cosette Pharmaceuticals is recalling specific lots of Mometasone Furoate Topical Solution due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1353-2021·2021-04-14

    Gf Health Products Recalls Drop Arm Versamode Due to Incorrect Casters

    Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.

    Product
    Drop Arm Versamode"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2021·2021-04-14

    Nuvasive PRECICE Limb Lengthening System Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics is recalling PRECICE limb lengthening devices because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0392-2021·2021-04-14

    Horizon Nut Company Recalls Pistachios for Pesticide Residue

    Horizon Nut Company is recalling roasted salted in-shell pistachios because they may contain low levels of the pesticide imidacloprid above the legal limit.

    Product
    Roasted Salted In shell Pistachios 3 lb. bag, 25 lb cartons, 30 lb. cartons, 50 lb. sacks, 2,000 lb. sacks, 2,200 lb sacks Packed by horizon Nut Company Tulare, CA 93274 Product of U.S.A.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0323-2021·2021-04-14

    Washington Homeopathic Products Recalls LCL-2-0191 Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling LCL-2-0191 because it was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1354-2021·2021-04-14

    Integra LifeSciences Recalls CODMAN HAKIM BACTISEAL Shunt Catheters Due to Labeling Error

    Integra LifeSciences is recalling 49 units of CODMAN HAKIM BACTISEAL Shunt System catheters because they lacked required drainage holes and markings.

    Product
    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-0431-2021·2021-04-14

    Toasted Oat Macadamia Chunk Granola Recalled for Mold-Containing Ingredient

    The Toasted Oat is recalling Macadamia Chunk Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Macadamia Chunk Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Macadamia Chunk ( 5 - 28.3g bars per pack/6 packs per case).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1364-2021·2021-04-14

    Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization

    Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.

    Product
    Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1359-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1351-2021·2021-04-14

    Nuvasive Freedom End Caps Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics Inc. is recalling 59 units of Freedom End Caps and related components because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1358-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Pro Series Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1356-2021·2021-04-14

    Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.

    Product
    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0424-2021·2021-04-14

    Babco Foods Recalls Anand Far Far Garlic Sandige for Undeclared Yellow 6

    Babco Foods International is recalling Anand Far Far (Garlic Sandige) because it contains undeclared Yellow 6, a food dye.

    Product
    Anand Far Far (Garlic Sandige) Net Weight 7 oz./200 g package ingredients: rice, wheat flour, garlic, red chilli, refined palm oil and salt. UPC 8 78776 00232 6 Product of India Imported and Distributed by Babco Foods International, LLC, Bridgewater, NJ
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1357-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set

    Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0433-2021·2021-04-14

    Toasted Oat Apricot Shortbread Granola Recalled for Mold Contamination

    The Toasted Oat is recalling Apricot Shortbread Soft Granola because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Apricot Shortbread Soft Granola (6 - 10oz pouches per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0328-2021·2021-04-14

    X-Gen Recalls Neomycin Sulfate Tablets Due to Microbiological Failure

    X-Gen Pharmaceuticals is recalling Neomycin Sulfate Tablets 500mg because a microbiological assay failed to meet stability specifications.

    Product
    Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0387-2021·2021-04-14

    Tippin's Country Gravy Recalled for Premature Spoilage Complaints

    Tippin's Country Gravy is being recalled due to consumer complaints of premature spoilage. The product was distributed to grocery stores in the Kansas City area.

    Product
    Tippin's Country Gravy, Net Wt 16 OZ, Keep Refrigerated, Tippin's Gourmet Pies LLC, Kansas City, KS UPC 6 80816 12023 1 packaged in plastic cups
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1352-2021·2021-04-14

    Clerio Vision Recalls Extreme H2O 59% Contact Lenses for Mislabeled Power

    Clerio Vision is recalling 153 Extreme H2O 59% contact lenses because they may be mislabeled with the incorrect lens power.

    Product
    EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1362-2021·2021-04-14

    Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0430-2021·2021-04-14

    Toasted Oat Blueberry Cobbler Granola Recalled for Mold Contamination

    The Toasted Oat is recalling Blueberry Cobbler Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Blueberry Cobbler Soft Granola (6 -10 oz pouches per case); and Soft Granola Crumble Bars Blueberry Cobbler (5 - 28.3g bars per pack/6 packs per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0385-2021·2021-04-14

    New Generation Wellness Recalls Vegan Vitamin D3 Tablets for Stability Issues

    New Generation Wellness Inc. is recalling 2,330 bottles of Vegan Vitamin D3 tablets because stability samples showed potency below the label claim.

    Product
    VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100cc amber glass bottles. UPC 7 19985 61831 4; UPC 6 10265 58337 0; UPC 4 01008 61831 8; UPC 4 02008 61831 5. Store in a cool, dry place. Product is sold under 72 private labels: A Moveable Feast; Akin's Natural…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0432-2021·2021-04-14

    Toasted Oat Cherry Streusel Granola Recalled for Mold-Containing Ingredient

    The Toasted Oat is recalling Cherry Streusel Soft Granola and Crumble Bars because an ingredient containing mold was used in production.

    Product
    The Toasted Oat Bakehouse Cherry Streusel Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Cherry Streusel ( 5 - 28.3g bars per pack/6 packs per case)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0319-2021·2021-04-14

    Kimberly-Clark Recalls Scott Moisturizing Foam Hand Sanitizer Due to Labeling Error

    Kimberly-Clark is recalling Scott Moisturizing Foam Hand Sanitizer because some bottles containing Foam Skin Cleanser soap are incorrectly labeled as hand sanitizer.

    Product
    Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2021·2021-04-14

    Tenderneeds Fertility Recalls Professional Artificial Intrauterine Insemination Kit

    Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1350-2021·2021-04-14

    Nuvasive Precice Unyte Orthopedic Rods Recalled for Missing Biological Assessments

    Nuvasive Specialized Orthopedics is recalling Precice Unyte orthopedic trauma nails because they lack full biological assessments and are not indicated for patients under 18.

    Product
    NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0436-2021·2021-04-14

    Sea World Recalls Crimson Snapper Fillets Due to Decomposition

    Sea World, LLC is voluntarily recalling 298 cases of Crimson Snapper Fillets due to fish decomposition. The product was distributed domestically in Puerto Rico.

    Product
    Crimson Snapper Fillet, Natural Cut CO Treated, Net WT 10 LBS, Size 10/12 oz
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0325-2021·2021-04-14

    Sun Pharmaceutical Recalls Metformin Hydrochloride Extended-Release Tablets

    Sun Pharmaceutical Industries is recalling 2,520 bottles of Metformin Hydrochloride Extended-Release Tablets due to failed moisture limits.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0321-2021·2021-04-14

    Washington Homeopathic Recalls Macula Pellets Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling Macula Pellets Homeopathic Medicine because the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0322-2021·2021-04-14

    Washington Homeopathic Products Recalls Sp-4 Solution Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling 114 bottles of Sp-4 solution because the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Food)·F-0384-2021·2021-04-14

    CVS Live Better Vitamin D3 Recalled for Stability Issues

    New Generation Wellness Inc. is recalling Live Better vegan vitamin D-3 tablets because stability samples showed less than 100% of the label claim.

    Product
    Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar, Distributed by: CVS Pharmacy, Inc. one CVS Drive, Woonsocket, RI 02895, UPC 0 50428 62499 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V258000·2021-04-13

    2021 Newmar Motorhomes Recall: Steering Column Shaft Disengagement Risk

    Newmar is recalling certain 2021 motorhomes due to a steering output shaft that may be too short and disengage from the input shaft, potentially causing loss of steering control and increased crash risk. Owners should contact Newmar for free inspection and replacement.

    Product
    NEWMAR — NEWMAR NEW AIRE, DUTCH STAR, MOUNTAIN AIRE, LONDON AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V260000·2021-04-13

    Kia Recalls 2017-2018 Forte Vehicles Due to Oil Pump Defect

    Kia is recalling 2017-2018 Forte vehicles with 2.0L engines because foreign particles may cause oil pump failure and engine damage.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V262000·2021-04-13

    Kenworth Recalls 2022 Trucks Due to Starter Interlock Defect

    PACCAR is recalling 2022 Kenworth T440, T470, T800, and W900 trucks because the starter interrupt may allow starting when the transmission is not in PARK.

    Product
    KENWORTH — KENWORTH T800B, W990, T440, T470
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V259000·2021-04-13

    2021 KIA SELTOS Engine Defect May Cause Stall or Fire

    Kia is recalling 2021 Seltos and 2020-2021 Soul vehicles due to improperly heat-treated piston rings that may cause engine damage, stalling, and crash risk, or oil leaks that may cause fires.

    Product
    KIA — KIA SOUL, SELTOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V261000·2021-04-13

    Tropos Recalls 2019 ABLE ST Vehicles for Speed Limit Defect

    Tropos is recalling 2019 ABLE ST vehicles because the motor controller firmware may allow speeds over 25 mph, violating federal safety standards.

    Product
    TROPOS — TROPOS ABLE ST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·21108·2021-04-12

    Black Diamond Recalls PIEPS DSP Avalanche Transceivers Due to Signal Loss Risk

    Black Diamond is recalling PIEPS DSP avalanche transceivers because they may switch modes unexpectedly, preventing signal transmission. One death and one injury have been reported.

    Product
    PIEPS DSP Pro, DSP Pro Ice, and DSP Sport Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V256000·2021-04-12

    2021-2022 Freightliner and Western Star trucks recalled for steering bolt defects

    Daimler Trucks North America is recalling 2021-2022 Freightliner and Western Star commercial trucks with defective steering bolts that may fracture and cause loss of steering control. Dealers will replace them free of charge.

    Product
    FCCC — FCCC, FREIGHTLINER, WESTERN STAR MT55, CUSTOM CHASS S2, CASCADIA, MT45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V255000·2021-04-12

    School Bus Steering System Bolts May Fracture and Cause Crashes

    Daimler Trucks recalls 2021-2022 Thomas Built school buses due to steering arm and tie rod bolts with defective seams that may fracture. A fractured bolt could cause loss of steering control and increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V254000·2021-04-12

    Palfinger Roll-Off and Hoist Recall for Tarp Arm Fatigue Failure

    Omaha Standard is recalling 2019-2021 Palfinger American Roll-Off, Cable Hoist, and Hook Lift units because welded gusset fatigue may cause tarp arms to break.

    Product
    PALFINGER — PALFINGER AMERICAN ROLL OFF, CABLE HOIST, HOOK LIFT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V253000·2021-04-12

    Blue Bird Recalls 2018-2021 School Buses for Electrical Fault Detection Issue

    Blue Bird is recalling 2018-2021 Vision and All American school buses because the electric drive train may fail to detect high-voltage isolation faults, posing a shock risk to service personnel.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04102021·2021-04-10

    USDA Issues Public Health Alert for Raw Ground Turkey Linked to Salmonella

    USDA FSIS issued a public health alert for raw ground turkey products from Plainville Brands, LLC, linked to a multistate Salmonella Hadar outbreak.

    Product
    Plainville Farms — FSIS Issues Public Health Alert for Raw Ground Turkey Products Linked to Salmonella Hadar Illness
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V252000·2021-04-10

    Spartan Fire Recalls 2019-2021 Gladiator and MetroStar for Steering Defect

    Spartan Fire is recalling 2019-2021 Gladiator and MetroStar vehicles because pressure in the power steering pump may break the shaft seal, causing a loss of steering assist.

    Product
    SPARTAN FIRE — SPARTAN FIRE GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E026000·2021-04-09

    BorgWarner Recalls Ford and GM Start Stop Accumulators for Oil Leak Risk

    BorgWarner is recalling specific Ford and GM start/stop accumulators because missing or loose bolts may cause oil leaks, increasing the risk of transmission failure or fire.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V251000·2021-04-09

    Yamaha Recalls 2015-2020 XC155 Scooters Due to Loose Nut Hazard

    Yamaha is recalling 2015-2020 XC155 scooters because a primary sheave nut may loosen and fall off, potentially causing the engine to stall and increasing crash risk.

    Product
    YAMAHA — YAMAHA SMAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V250000·2021-04-09

    Keystone Bullet RV trailers recalled for defective emergency window handle

    Keystone is recalling certain 2020-2021 Bullet trailers with defective bedroom emergency egress windows. An incorrect crank handle may make the window difficult to open in an emergency.

    Product
    KEYSTONE — KEYSTONE BULLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E025000·2021-04-08

    Meritor Recalls TSE T2024 Air Brake Chambers Due to Spring Defect

    Meritor is recalling specific TSE T2024 Air Brake Chambers because incorrect springs may cause the pressure plate to shift, potentially leading to a loss of air pressure and increased crash risk.

    Product
    SERVICE BRAKES, AIR:DISC:CHAMBER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V248000·2021-04-08

    Jaguar Recalls XE Vehicles for Weak Rear Rail Assembly

    Jaguar is recalling 2017-2018 and 2020 XE vehicles because missing spot welds may weaken the rear rail assembly, increasing the risk of a crash during towing.

    Product
    JAGUAR — JAGUAR XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V246000·2021-04-08

    GM Recalls Buick, Chevrolet, and GMC SUVs for Air Bag Defect

    General Motors is recalling specific Buick, Chevrolet, and GMC SUVs because side curtain air bags may not be properly attached, increasing injury risk.

    Product
    BUICK — BUICK, CHEVROLET, GMC ENCLAVE, TRAVERSE, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V245000·2021-04-08

    GM Recalls 2014-2016 Trucks and SUVs for Seat Belt Cable Defect

    General Motors is recalling specific 2014-2016 Chevrolet and GMC vehicles because a driver's seat belt cable may break, reducing safety protection.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500, TAHOE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21736·2021-04-08

    GEO Essential Oils Recalled for Non-Child-Resistant Packaging and Poisoning Risk

    Geo Essential LLC is recalling Wintergreen and Alleviate essential oils because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    GEO Wintergreen Organic Essential Oil and GEO Alleviate Organic Essential Oil Blend
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0356-2021·2021-04-07

    Wilton Valentine Chip Crunch Sprinkles Recalled for Undeclared Milk

    Wilton Industries Inc. is voluntarily recalling 1,638 units of Valentine Chip Crunch Sprinkles nationwide due to undeclared milk.

    Product
    Wilton Valentine Chip Crunch Sprinkles, 3.46 oz (98g) clear plastic bottle, SKU 710-4277 UPC 070896042774
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0378-2021·2021-04-07

    Kareem Chef Halva with Pistachio Recalled for Salmonella Risk

    Kareem Mart Inc. is recalling Kareem Chef Halva with Pistachio due to a potential Salmonella contamination risk.

    Product
    Kareem Chef Halva with Pistachio 1lb and 2lb sizes in plastic tub
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0377-2021·2021-04-07

    Kareem Chef Halva Recalled Due to Salmonella Contamination Risk

    Kareem Mart Inc. is voluntarily recalling Kareem Chef Halva in 1lb and 2lb plastic tubs due to a potential Salmonella contamination risk.

    Product
    Kareem Chef Halva 1lb and 2lb sizes in plastic tub
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0358-2021·2021-04-07

    Wilton Rainbow Chip Crunch Sprinkles Recalled for Undeclared Milk

    Wilton Industries is recalling Rainbow Chip Crunch Sprinkles nationwide due to undeclared milk, a major food allergen.

    Product
    Wilton Rainbow Chip Crunch Sprinkles, 5.25oz (148g) clear plastic bottle, SKU 710-9704 UPC 070896797049
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0379-2021·2021-04-07

    Kareem Chef Halva with Chocolate Recalled for Salmonella Risk

    Kareem Mart Inc. is voluntarily recalling 600 units of Kareem Chef Halva with Chocolate due to a potential Salmonella contamination risk.

    Product
    Kareem Chef Halva with Chocolate 1lb size in plastic tub
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0360-2021·2021-04-07

    Wilton Holiday Home Treat Toppings Recalled for Undeclared Milk

    Wilton Industries is recalling Holiday Home Assorted Treat Toppings nationwide due to undeclared milk, a major allergen.

    Product
    Holiday Home Assorted Treat Toppings, 2.6oz (74g) 3 hanging clear plastic bags with 1 paperboard card, SKU 710-0-0207 UPC 041226473612
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1334-2021·2021-04-07

    CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

    FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

    Product
    CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1259-2021·2021-04-07

    Smisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1258-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets because a toxicological assessment found potential for aluminum ions to leach into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2021·2021-04-07

    Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

    Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

    Product
    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1260-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling 1,638 packs of Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1335-2021·2021-04-07

    FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

    The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

    Product
    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·21104·2021-04-07

    Goal Zero Recalls EC8 Power Cables Due to Fire Hazard

    Goal Zero is recalling about 7,850 EC8 power cables because the connector pins can deform and overheat, posing a fire hazard. Four reports of overheating or fire have been received, with no injuries.

    Product
    EC8 Power Cables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0361-2021·2021-04-07

    Nuts.com Diced Dried Figs Recalled for Undeclared Almonds

    Nuts.com is recalling diced dried figs because they contain undeclared almonds, a major food allergen.

    Product
    Nuts.com brand Diced Dried Figs packaged in 1lb stand up gusset pouches.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0357-2021·2021-04-07

    Wilton Holiday Mix Sprinkles Recalled for Undeclared Milk

    Wilton Industries is recalling 18,740 units of Holiday Mix Sprinkles nationwide due to undeclared milk, a major food allergen.

    Product
    Wilton Holiday Mix Sprinkles, 7.6oz (215g) clear plastic bottle, SKU 710-7649 UPC 070896276490
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0355-2021·2021-04-07

    Wilton Rainbow Chip Crunch Sprinkles Recalled for Undeclared Milk

    Wilton Industries is recalling Rainbow Chip Crunch Sprinkles nationwide due to undeclared milk, a major food allergen.

    Product
    Wilton Rainbow Chip Crunch Sprinkles, 5.25 oz (148g) clear plastic bottle, SKU 710-5364 UPC 070896453648
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0359-2021·2021-04-07

    Wilton Autumn Sprinkles Recalled for Undeclared Milk Allergen

    Wilton Industries is recalling 8,742 units of Autumn Assorted Treat Toppings Sprinkles nationwide due to undeclared milk.

    Product
    Wilton Autumn Assorted Treat Toppings Sprinkles, 2.6oz (74g) 3 hanging clear plastic bags with 1 paperboard card, SKU 710-9722 UPC 070896097224
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1306-2021·2021-04-07

    Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time

    Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.

    Product
    Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1309-2021·2021-04-07

    CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress

    CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.

    Product
    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V244000·2021-04-07

    New Flyer Recalls Electric Buses Due to Inverter Firmware Errors

    New Flyer is recalling certain 2013-2021 electric buses because firmware errors in the inverters may cause the electric drive system to shut down, increasing the risk of a crash.

    Product
    NEW FLYER — NEW FLYER XE60, XE35, XE40, XHE40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2021·2021-04-07

    Medtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure

    Medtronic is recalling Bio-Console 560 devices because an electrical component may fail, causing the pump to stop and potentially producing smoke or a burning odor.

    Product
    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V243000·2021-04-07

    Utility Trailer Recalls VS2DC, VS2DX, VS3DX Models for Missing Weld

    Utility Trailer is recalling 2006-2021 VS2DC, VS2DX, and VS3DX trailers because a missing weld may cause the slider rail to detach, increasing crash risk.

    Product
    UTILITY TRAILER — UTILITY TRAILER VS3DX, VS2DX, VS2DC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2021·2021-04-07

    Siemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations

    Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.

    Product
    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-0365-2021·2021-04-07

    Blanxart Milk Chocolate with Hazelnuts Recalled for Metal Fragment

    Culinary Collective is recalling Blanxart Milk Chocolate with Hazelnuts because a small metal fragment was found inside a bar.

    Product
    Blanxart Milk Chocolate with Hazelnuts Cacao 33% Min. Net wt.7 oz. Product is packaged with paper and internal foil wrapper. UPC 6 66785 20322 9. The label is read in parts: "***BLANXART Milk Chocolate with Hazelnuts CACAO 33% *** BB Chocolate Grup, S.A Tambor del Bruc 13 08970…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0369-2021·2021-04-07

    Caribou Coffee Turkey Sandwich Recalled for Listeria Contamination Risk

    J & J Distributing Company is recalling Caribou Coffee Turkey Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed to 46 retail locations in eight states.

    Product
    Caribou Coffee Turkey Sandwich, Net Wt. 9.0oz. (255g)
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1323-2021·2021-04-07

    Nuvasive PRECICE STRYDE Intramedullary Nail Recall for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling PRECICE STRYDE intramedullary nails due to complaints of adverse events potentially related to biological safety, including pain and bony abnormalities.

    Product
    PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21103·2021-04-07

    Epicure Recalls Glass Prep Bowls Due to Laceration Hazard

    Epicure is recalling glass prep bowls that may shatter during use, posing a laceration hazard. Consumers should stop using the product and contact Epicure for a free replacement.

    Product
    Epicure Prep Bowls (Set of Four)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0380-2021·2021-04-07

    Land O'Lakes Queso Dip Recalled for Potential Metal Foreign Material

    Land O'Lakes is recalling Queso Bravo White Cheese Dip because it may contain metal foreign material. Consumers should stop using the product.

    Product
    Land O Lakes Queso Bravo White Cheese Dip with Jalapeno and Red Peppers. Net Wt 5 lbs. (2.26kg), UPC 34500-48238. Shipping Case: 6 - 5 lb Pouches. Net Wt. 20.00 Lbs. (13.60 kg) Item Code 48238000034500
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0371-2021·2021-04-07

    Earthgrown Mini Taco Dip Recalled for Listeria Contamination Risk

    J & J Distributing Company is recalling Earthgrown Mini Taco Dip due to potential Listeria monocytogenes contamination. The product was distributed to 46 retail locations in eight states.

    Product
    Earthgrown Mini Taco Dip, Net Wt. 8oz. (227g), UPC 6 10014 22341 0, Packed By J&J Distributing Inc. 653 Rice St, St Paul, MN 55103
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1318-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·21102·2021-04-07

    RH Recalls Children's Bath Wraps for Flammability Standard Violations

    RH is recalling approximately 55,700 children's bath wraps in the U.S. because they fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries.

    Product
    Animal, Heathered Plush and Luxe Sherpa Children's Bath Wraps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2021·2021-04-07

    J & J Distributing Recalls Taco Dip for Listeria Risk

    J & J Distributing Company is recalling 8-ounce Kwik Trip Taco Dip due to potential Listeria monocytogenes contamination. The product was distributed to 46 retail locations in eight states.

    Product
    Taco Dip [Kwik Trip], Net Wt. 8oz (227g), UPC 0 38232 36091 3, Distributed By H. Brooks & Co. Mpls MN 55112
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0372-2021·2021-04-07

    Haug Fresh Mini 7 Layer Dip Tray Recalled for Listeria Risk

    J & J Distributing Company is recalling Haug Fresh Mini 7 Layer Dip Trays due to potential Listeria monocytogenes contamination.

    Product
    Haug Fresh Mini 7 Layer Dip Tray, Net Wt. 22oz (624g), UPC 6 10014 16414 0, Packed and Distributed by J&J Distributing, St Paul Mn 55103
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1320-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 18 units of DiamondTemp Bidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1324-2021·2021-04-07

    Nuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling 226 Precice Bone Transport nails due to complaints of pain and bony abnormalities related to biological safety.

    Product
    Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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