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.

8426–8450 of 29123

  • 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 XHE40, XE60, XE35, XE40
    Category
    Vehicle
    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 (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
  • 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-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-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
  • 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
  • SevereUSDA FSIS·011-2021·2021-04-01

    Rong Shing Trading Recalls Ineligible Chinese Beef Hot Pot Base

    Rong Shing Trading Inc. is recalling approximately 3,365 pounds of Chinese-style hot pot base containing beef tallow imported from China, a country ineligible to export beef to the U.S.

    Product
    Rong Shing Trading Inc. Recalls Ineligible Beef Products Imported from China
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V229000·2021-04-01

    Mercedes-Benz Recalls Vehicles for Steering Shaft Bearing Separation Risk

    Mercedes-Benz is recalling specific 2017-2018 models because a steering shaft defect could cause loss of control. Dealers will inspect and replace the shaft free of charge.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250, CLA250, AMG CLA45, AMG GLA45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1282-2021·2021-03-31

    Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error

    Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.

    Product
    Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2021·2021-03-31

    Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities

    Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.

    Product
    Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0353-2021·2021-03-31

    Gelson's Yogurt Raisins Recalled for Potential Peanut Contamination

    Western Mixers Produce & Nuts, Inc. is recalling Gelson's Yogurt Raisins because the product may contain peanuts, which are not listed on the label.

    Product
    Gelson's Yogurt Raisins, Plastic Clamshell Container NET WT 14 oz. (397g) UPC: 7 97565 20470 6 Contains: Milk, Soy. Packed in a facility that handles Peanuts, Tree Nuts, Wheat, Soy, Egg, and Milk products. Product of USA, Distributed by Gelson's, Encino, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0346-2021·2021-03-31

    El Abuelito Requeson Ricotta Recalled Due to Listeria Contamination Risk

    El Abuelito Cheese, Inc. is recalling specific 12oz containers of Requeson Ricotta because the product may be contaminated with Listeria monocytogenes.

    Product
    Requeson/Ricotta, sold under the following brands and container sizes: El Abuelito Requeson Ricotta 12oz Clam Shell Container, UPC: 673130300014; El Abuelito Requeson Ricotta - Promocion $3.99 12oz. Clam Shell Container, UPC: 673130300014; El Viejito Requeson/Ricotta 12oz. Clam S
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1280-2021·2021-03-31

    Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1307-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect

    Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.

    Product
    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards desi
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2021·2021-03-31

    Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings

    Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.

    Product
    CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V217000·2021-03-26

    Mercedes-Benz Recalls AMG Models Due to Starter Cable Fire Risk

    Mercedes-Benz is recalling 493 AMG E63S and GT63 models because an incorrectly installed starter cable may chafe wires, causing a short circuit, vehicle stall, or fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG E63S, AMG GT63, AMG GT63S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V215000·2021-03-25

    Honda and Acura Recall Vehicles for Fuel Pump Failure Risk

    Honda is recalling 2018-2020 Acura and Honda vehicles because the fuel pump may fail, causing the engine to stall while driving.

    Product
    ACURA — ACURA, HONDA RDX, CR-V, CIVIC, ILX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V214000·2021-03-25

    RV Chassis steering column defect may cause loss of steering

    Shyft Group is recalling certain 2021-2022 Spartan RV Chassis K1-K4 vehicles. A steering column defect may cause the steering output shaft to disengage, resulting in loss of steering control and crash risk.

    Product
    SPARTAN — SPARTAN K3, K4, K2, K1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21732·2021-03-25

    Polaris Recalls Ranger and Utility Vehicles Due to Fire Hazard

    Polaris is recalling approximately 41,500 Ranger, ProXD, Gravely, and Bobcat off-road vehicles because a drive belt can break, damage the fuel line, and cause a fire.

    Product
    Model Year 2020-2021 RANGER 1000 and RANGER CREW 1000, Model Year 2020 ProXD 2000G and 4000G, Model Year 2020-2021 Ariens/Gravely JSV3200, JSV3400, and JSV6400, Model Year 2020 Bobcat UV34 4x4 GAS and UV34 XL GAS, and Model Year 2021 Bobcat UV34 4x4 GAS
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V210000·2021-03-25

    2021 Chevrolet Tahoe seat belt latch may be inaccessible

    GM is recalling certain 2021 Chevrolet Tahoe vehicles because the second-row center seat belt latch may be trapped beneath the trim bezel. Passengers cannot use this seat belt, increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET TAHOE
    Category
    Vehicle
    Distribution
    Distributed nationwide