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.

9251–9275 of 29156

  • SevereFDA (Devices)·Z-2880-2020·2020-09-02

    Biosense Webster Recalls CARTO 3 System Software Due to Defect

    Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.

    Product
    CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V534000·2020-09-02

    Tiffin Recalls 2020 Bus and Phaeton Motorhomes for Steering Bolt Issue

    Tiffin Motorhomes is recalling 2020 Bus and Phaeton models because steering pinch bolts may not be properly tightened, which could lead to a loss of steering control.

    Product
    TIFFIN — TIFFIN BUS, PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2858-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1550-2020·2020-09-02

    SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination

    SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.

    Product
    Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1260-2020·2020-09-02

    Emerald Fruit & Produce Recalls Sliced Onions for Salmonella Risk

    Emerald Fruit & Produce is recalling sliced yellow onions for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60026CS Onions Yellow Sliced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1268-2020·2020-09-02

    Emerald Fruit & Produce Recalls Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling diced onions sold for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60058CS Onions White Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1265-2020·2020-09-02

    Emerald Fruit & Produce Recalls Unlabeled Red Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 80 lbs of unlabeled red onions in Oregon due to potential Salmonella Newport contamination.

    Product
    Onions Red Whole Dry 5 lb. bag (item 78156) for food service use, shelf life 14 days, packed in 5 lbs. cello bag and stored in box - No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1264-2020·2020-09-02

    Emerald Fruit & Produce Recalls Red Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc is recalling 45 lbs of red diced onions sold in Oregon due to potential Salmonella Newport contamination.

    Product
    M60022CS Onions Red Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1262-2020·2020-09-02

    Emerald Fruit & Produce Recalls Peeled Onions for Salmonella Newport Risk

    Emerald Fruit & Produce Inc is recalling 160 lbs of peeled yellow onions for foodservice use in Oregon due to potential Salmonella Newport contamination.

    Product
    M60027CS Onions Yellow Whole Peeled sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1543-2020·2020-09-02

    Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations

    Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2854-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2856-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1256-2020·2020-09-02

    Progressive Produce Recalls Yellow Onions Supplied by Thomson Onions

    Progressive Produce LLC is recalling yellow onions supplied by Thomson Onions. The onions were distributed for retail sale in bulk bins.

    Product
    Yellow Onions; Pacific Gold 50 Lb. SX Yellow onion w/PLU sticker Sold to consumers in bulk bins
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1266-2020·2020-09-02

    Emerald Fruit & Produce Recalls Red Onions for Salmonella Newport Risk

    Emerald Fruit & Produce Inc is recalling M60024CS Red Whole Peeled Onions due to potential Salmonella Newport contamination. The product was distributed in Oregon for foodservice use.

    Product
    M60024CS Onions Red Whole Peeled sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1261-2020·2020-09-02

    Emerald Fruit & Produce Recalls Diced Onions for Salmonella Risk

    Emerald Fruit & Produce Inc. is recalling diced yellow onions for foodservice use due to potential Salmonella Newport contamination.

    Product
    M60025CS Onions Yellow Diced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2869-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V531000·2020-09-02

    Gulf Stream Enlighten Travel Trailer Recall for Refrigerator Seal Defect

    Gulf Stream is recalling 2020 Enlighten travel trailers because a missing refrigerator trim strip may allow carbon monoxide or flammable gas to enter the living area.

    Product
    GULF STREAM — GULF STREAM ENLIGHTEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2020·2020-09-02

    Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire

    Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V521000·2020-08-28

    Heartland Bighorn Traveler landing legs may collapse causing trailer to drop

    Certain 2019-2021 Heartland Cyclone, 2020-2021 Bighorn Traveler, and 2020-2021 Elkridge recreational trailers may have insufficient bracing on the front landing legs, which could buckle and collapse while parked, causing the trailer to drop unexpectedly.

    Product
    HEARTLAND — HEARTLAND CYCLONE, ELKRIDGE, BIGHORN TRAVELER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V519000·2020-08-27

    Kia Recalls Optima and Sorento Models for Brake Fluid Leak Fire Risk

    Kia is recalling 2013-2015 Optima and 2014-2015 Sorento vehicles because brake fluid may leak inside the Hydraulic Electronic Control Unit, potentially causing an electrical short and engine compartment fire.

    Product
    KIA — KIA OPTIMA, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V511000·2020-08-27

    RAM 3500, 4500, 5500 Recall for Engine Oil Film Defect

    Chrysler is recalling 2019-2020 RAM 3500, 4500, and 5500 cab chassis vehicles due to a defect that can cause engine damage and fire risk.

    Product
    RAM — RAM 3500, 5500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V520000·2020-08-27

    Hyundai Recalls Santa Fe Sport Vehicles Due to Brake Fluid Leak Risk

    Hyundai is recalling 2013-2015 Santa Fe Sport vehicles because brake fluid may leak inside the ABS module, creating a risk of engine compartment fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V510000·2020-08-27

    Vac-Tron Recalls 140 Trucks for Rear Extremity Safety Defect

    Vac-Tron is recalling 140 trucks because the rear extends too far, increasing injury risk in rear-end crashes.

    Product
    VAC-TRON — VAC-TRON JTV 873 PTO, HTV 373 PTO, HTV 873 PTO, HTV 573 PTO
    Category
    Vehicle
    Distribution
    Distributed nationwide