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.

5676–5700 of 29102

  • SevereFDA (Devices)·Z-1057-2023·2023-02-15

    GE Nuclear Medicine Systems Recall Due to Potential Detector Fall Hazard

    GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause life-threatening injury.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0376-2023·2023-02-15

    Utopia brand Enoki Mushrooms recalled due to Listeria contamination

    Utopia brand Enoki Mushrooms (200g bags, UPC 892891861017) distributed in New York and New Jersey may be contaminated with Listeria monocytogenes. Consumers should not eat these mushrooms and should discard them or return them to the store.

    Product
    Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product of China; Distributed by Utopia Foods Inc.; UPC 892891861017; packaged in blue and clear plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1055-2023·2023-02-15

    GE Nuclear Medicine BRIVO B615 Imaging System Detector Fall Risk

    GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emissio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1054-2023·2023-02-15

    GE Nuclear Medicine Systems: Detector Fall Risk Due to Faulty Mitigation

    GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily injury.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1053-2023·2023-02-15

    GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk

    GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.

    Product
    GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V083000·2023-02-15

    New Flyer Recalls Electric Buses Due to Battery Fire Risk

    New Flyer is recalling 2021-2023 XE35, XE40, and XE60 electric buses because liquid accumulation in battery packs may cause electrical shorts and fires.

    Product
    NEW FLYER — NEW FLYER XE40, XE60, XE35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V079000·2023-02-14

    2022-2023 BMW IX and X1 driver airbag may fail to deploy in crash

    Certain 2022 and 2023 BMW IX and X1 vehicles have defective driver-side airbags that may not deploy during a crash. Dealers will replace the airbags at no charge.

    Product
    BMW — BMW IX, X1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V073000·2023-02-10

    Freightliner Cascadia and Western Star trucks recalled for brake defect

    Daimler Trucks North America is recalling certain 2017-2023 Freightliner Cascadia and Western Star trucks. Corroded brake modulator valves may cause vehicles to pull to one side during braking, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 47X, CASCADIA, 49X, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V074000·2023-02-10

    Mercedes-Benz Recalls 2022 EQS 580 for Windshield Camera Attachment Defect

    Mercedes-Benz is recalling 2022 EQS 580 vehicles because the windshield-mounted camera and rearview mirror may detach, potentially impairing air bag deployment and driver assistance systems.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V066000·2023-02-10

    Navistar Recalls 2022-2023 IC Bus CE and RE Models for Roof Defect

    Navistar is recalling 2022-2023 IC Bus CE and RE transit buses because roof panels may have insufficient joint strength, increasing injury risk in a crash.

    Product
    IC BUS — IC BUS CE, RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E010000·2023-02-09

    Chrysler Recalls Mopar Intake Heater Grid Relays for Fire Risk

    Chrysler is recalling Mopar Generation 1 Intake Heater Grid Relays because an electrical short can cause an engine compartment fire. Owners should park vehicles outside until the free repair is completed.

    Product
    ELECTRICAL SYSTEM:WIRING:RELAYS/SOLENOIDS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2023·2023-02-08

    FDA Recalls Easy Care First Aid Kits for Bacterial Contamination

    GFA Production's Easy Care First Aid 25 Person kits are being recalled nationwide due to contamination with Bacillus bacteria. The affected first aid cream packets could pose a risk if applied to open wounds.

    Product
    Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0963-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms

    Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2023·2023-02-08

    Easy Care First Aid Kit Recalled for Microbial Contamination

    The FDA is recalling Easy Care First Aid kits containing After Burn Cream due to microbial contamination. The affected product was distributed nationwide and in Canada with lot number W06H15 (expiration August 15, 2024).

    Product
    Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2023·2023-02-08

    FDA Recalls Easy Care First Aid Kit for Bacterial Contamination

    The FDA is recalling Easy Care First Aid Kits with contaminated After Burn Cream packets distributed nationwide and in Canada. Lab testing identified Bacillus lichenformis and Bacillus sonorensis contamination.

    Product
    Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0966-2023·2023-02-08

    CADD Administration Sets recall for delivery failure and false alarms

    Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2023·2023-02-08

    CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms

    Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2023·2023-02-08

    SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization

    Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.

    Product
    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0962-2023·2023-02-08

    CADD Administration Set recall: medication underdelivery and false alarms

    Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
    Category
    Medical Device
    Distribution
    Distributed nationwide