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.

3651–3675 of 29102

  • SevereCPSC·24109·2024-02-08

    Vornado Handheld Garment Steamers Recalled for Burn Hazard

    Vornado, Steamfast, and Sharper Image-branded handheld garment steamers can expel hot water from the steam nozzle, posing a serious burn hazard. About 2 million units sold nationwide are affected.

    Product
    Steamfast, Vornado and Sharper Image-branded handheld garment steamers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V093000·2024-02-08

    2024 FCCC MT45 and Freightliner Cascadia steering gear recall

    Daimler Trucks North America is recalling certain 2024 FCCC MT45 and Freightliner Cascadia vehicles due to steering gear assembly defects that may result in loss of steering control. Contact dealers or call 1-800-745-8000 for free replacement of the affected component.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC CASCADIA, MT45G, MT45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0940-2024·2024-02-07

    Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures

    Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.

    Product
    EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V081000·2024-02-07

    Suzuki Recalls 2024 GSX-8R Motorcycles for Drive Chain Defect

    Suzuki is recalling 2024 GSX-8R motorcycles because the drive chain may detach due to missing rivets, which can cause a loss of power to the rear wheels and increase crash risk.

    Product
    SUZUKI — SUZUKI GSX-8R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0775-2024·2024-02-07

    FDA recalls EVair 03 compressor models for elevated formaldehyde levels

    FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).

    Product
    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0939-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues

    Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.

    Product
    EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2024·2024-02-07

    Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall

    The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.

    Product
    smiths medical Medfusion Model 4000 syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0941-2024·2024-02-07

    Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures

    Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.

    Product
    EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0863-2024·2024-02-07

    Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects

    Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.

    Product
    smiths medical Medfusion Model 3500 Syringe pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0774-2024·2024-02-07

    EVair Air Compressors Recalled for Elevated Formaldehyde Emissions

    EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.

    Product
    EVair air compressor, model numbers: M1230849 and M1230847
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2024·2024-02-07

    Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues

    Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.

    Product
    EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0942-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk

    Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.

    Product
    EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0917-2024·2024-02-07

    Cheese product recalled for Listeria monocytogenes contamination

    Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.

    Product
    Tio Francisco Blanco Suave 14 oz. UPC 7-27242-05355-6
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0921-2024·2024-02-07

    Panela Cheese Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods is recalling Tio Francisco and related panela cheese products due to potential Listeria monocytogenes contamination. Affected products were distributed across multiple states.

    Product
    Tio Francisco Panela 14 oz. UPC 7-27242-00550-0 Food City Panela 16 oz. Tio Francisco, San Carlos, Dos Ranchitos, La Ordena, Campesino Panela Available to consumers at retail deli counters in various sizes Tio Francisco Panela Barra Available to consumers at retail deli counte
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0925-2024·2024-02-07

    Ricotta cheese products recalled for Listeria monocytogenes contamination

    Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.

    Product
    365 Whole Foods Market Ricotta Part Skim 15 oz. UPC 9-94824-63052 365 Whole Foods Market Ricotta Whole Milk 15 oz. UPC 9-94824-96245 Ricotta Part Skim 65%, 70%, 75% Moisture (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0920-2024·2024-02-07

    Oaxaca Cheese Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods recalled Oaxaca cheese products sold under multiple brand names due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states.

    Product
    Rizo Bros. Oaxaca 8 oz. UPC 7-27242-00334-6 Tio Francisco Oaxaca 12 oz. UPC 7-27242-12332-7 Tio Francisco Oaxaca 14 oz. UPC 7-27242-00532-6 Food City Oaxaca 16 oz. Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Tio Francisco Oaxaca
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0278-2024·2024-02-07

    FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction

    FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.

    Product
    FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0928-2024·2024-02-07

    Monterey Jack Cheese Recalled for Listeria Monocytogenes Contamination

    Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.

    Product
    Monterey Jack Conventional (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0281-2024·2024-02-07

    Vancomycin IV bags recalled due to filling system malfunction causing double doses

    Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.

    Product
    VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0918-2024·2024-02-07

    Sour Cream Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods has recalled multiple sour cream and cream products due to Listeria monocytogenes contamination. Products were distributed across multiple U.S. states.

    Product
    Tio Francisco Crema Centroamericana 16 oz. UPC 7-27242-00440-4 Tio Francisco, Campesino Crema Centroamericana Available to consumers at retail deli counters in various sizes Tio Francisco Crema Latina 16 oz. UPC 7-27242-35445-5 Tio Francisco Crema Latina Available to consumer
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0922-2024·2024-02-07

    Tio Francisco Queso Para Freir Recalled Due to Listeria Contamination

    Tio Francisco Queso Para Freir (frying cheese) is being recalled due to potential Listeria monocytogenes contamination. The recall affects multiple batches distributed across multiple U.S. states.

    Product
    Tio Francisco Queso Para Freir 16 oz. Tio Francisco Queso Para Freir Available to consumers at retail deli counters in various sizes Freir (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0805-2024·2024-02-07

    Multiple Tuna Products Recalled Due to Listeria Monocytogenes Contamination

    Ocean Group Inc. is recalling tuna products distributed in California due to potential Listeria monocytogenes contamination identified through FDA environmental sampling.

    Product
    201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BLUEFIN SPAIN G&G SPAIN F LB 201508 TUNA BLUE FIN GG JAPAN FR JPN F LB 201900 TU
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0919-2024·2024-02-07

    Queso Fresco from Multiple Brands Recalled for Listeria Contamination

    Rizo Lopez Foods, Inc. is recalling various queso fresco products from multiple brands due to potential Listeria monocytogenes contamination. The affected products were distributed to retail locations in multiple U.S. states.

    Product
    Tio Francisco, El Huache, La Ordena Fresco (Michoacano) Available to consumers at retail deli counters in various sizes Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Rizo Bros. Queso 8 oz. UPC 7-27242-00159-5 Don Francisco 10 oz. UP
    Category
    Food
    Distribution
    20 states