The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

9676–9700 of 29157

  • SevereFDA (Food)·F-0938-2020·2020-05-13

    Medifast Recalls Optavia Oatmeal Pouches Due to Undeclared Milk

    Medifast is recalling Optavia Old Fashioned Maple & Brown Sugar Oatmeal pouches because they contain undeclared milk.

    Product
    Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per carton
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2020·2020-05-13

    Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation Risk

    Argon Medical Devices is recalling specific 0.035-inch guidewires because the soft tip stiffness caused tissue perforation. The affected units were distributed to several countries outside the US.

    Product
    0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0937-2020·2020-05-13

    Tainy Boctoka Dry Fruits Mix Recalled for Undeclared Sulfites

    Royal International Trading Inc. is recalling Tainy Boctoka Dry Fruits Mix because the product contains undeclared sulfites.

    Product
    TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) clear plastic package
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·20V270000·2020-05-13

    Porsche Recalls 2019-2020 Cayenne Models Due to Fuel Line Leak Risk

    Porsche is recalling 2,253 Cayenne vehicles because a fuel line connector may leak, increasing the risk of fire.

    Product
    PORSCHE — PORSCHE CAYENNE TURBO S HYB COUPE, CAYENNE S E-HYBRID, CAYENNE TURBO, CAYENNE TURBO COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1912-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1842-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1911-2020·2020-05-13

    ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.

    Product
    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1913-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1920-2020·2020-05-13

    ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error

    ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.

    Product
    REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
    Category
    Medical Device
    Distribution
    44 states
  • SevereNHTSA·20V274000·2020-05-13

    Audi Recalls 2020 A6, A7, and Allroad for Airbag Deployment Defect

    Volkswagen Group of America is recalling 2020 Audi A6, A7, and Allroad vehicles because the passenger airbag may not deploy properly, increasing injury risk.

    Product
    AUDI — AUDI ALLROAD, A6, A7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2020·2020-05-13

    Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation

    Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.

    Product
    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1843-2020·2020-05-13

    Philips TEE Transducers Recalled Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.

    Product
    Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocard
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.

    Product
    REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1865-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·009-2020·2020-05-12

    Ideal Foods Recalls Flatbread Pizzas Produced Without Federal Inspection

    Ideal Foods is recalling approximately 3,302 pounds of meat and poultry flatbread pizzas produced without federal inspection. No adverse reactions have been reported.

    Product
    Ideal Foods — Ideal Foods Recalls Meat and Poultry Flatbread Pizza Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·20V259000·2020-05-08

    Blue Bird Recalls 2020-2021 Vision and All American Transit Buses

    Blue Bird is recalling 2020-2021 Vision and 2021 All American buses because the parking brake may fail to hold the vehicle on an incline.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V261000·2020-05-08

    Maintainer Recalls 2019-2020 International and Chevrolet Tow Vehicles for PTO Defect

    Maintainer is recalling 16 modified 2019-2020 International CV and Chevrolet Silverado tow vehicles because incorrectly installed Power Take Offs may loosen, risking transmission fluid loss and rear wheel lockup.

    Product
    INTERNATIONAL MOTORS — INTERNATIONAL MOTORS, INTERNATIONAL CHEVY SILVERADO MEDIUM DUTY, CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V258000·2020-05-08

    Blue Bird Recalls 2020-2021 School Buses for Parking Brake Assembly Defect

    Blue Bird is recalling 2020-2021 Vision and All American school buses because the foot pedal parking brake assembly may be improperly assembled, potentially failing to hold the vehicle on an incline.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V255000·2020-05-07

    Navistar Recalls 2018-2020 International Trucks Due to Engine Defect

    Navistar is recalling 2018-2020 International LT and 2019-2020 RH trucks because a wrist pin bushing failure may cause unexpected engine shutdown and increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT, RH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V254000·2020-05-07

    GM Recalls 2015-2016 Chevrolet SS and Caprice for Steering Defect

    General Motors is recalling 2,281 vehicles due to potential loss of electric power steering assist caused by connector corrosion.

    Product
    CHEVROLET — CHEVROLET CHEVEROLET SS, CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0928-2020·2020-05-06

    Frozen Flounder Stuffed with Seafood Recalled for Undeclared Allergens

    Freedman Food Service is recalling frozen flounder stuffed with seafood due to undeclared wheat, soy, eggs, and milk.

    Product
    7126763 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 3.00 (1.36 KG), 4 packages per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1257-2020·2020-05-06

    B. Braun Recalls Ceftazidime and Dextrose Injection Due to Stability Failures

    B. Braun Medical Inc. is recalling one lot of Ceftazidime for Injection USP and Dextrose for Injection USP because the product failed stability specifications for high molecular weight polymers.

    Product
    Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
    Category
    Medical Device
    Distribution
    Distributed nationwide