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.

5701–5725 of 29108

  • SevereFDA (Food)·F-0338-2023·2023-02-08

    Wegmans tiramisu products contain undeclared wheat

    Wegmans bakery tiramisu products contain undeclared wheat not listed on the label. The products are marked as made with no gluten-containing ingredients but do not declare wheat as an allergen.

    Product
    Wegmans bakery Tiramisu, Half Tiramisu, and Tiramisu Slices; Made with No Gluten-Containing Ingredients; ALLERGENS: Contains Egg, Milk, Soy, Other allergens may be present due to shared preparation area.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0252-2023·2023-02-08

    CVS First Aid Home Burn Cream Packets Recalled for Bacterial Contamination

    CVS First Aid Home, First Aid Kit burn cream packets have been recalled due to bacterial contamination. The product contains Bacillus lichenformis and Bacillus sonorensis bacteria, creating a risk when applied to wounds or burns.

    Product
    CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0964-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms

    FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
    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
  • 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 (Drugs)·D-0245-2023·2023-02-08

    First Aid Kit Product Recalled Due to Bacterial Contamination

    A first aid kit containing topical burn cream has been recalled due to bacterial contamination with Bacillus species. The product (Lot W06I20) was distributed nationwide and in Canada.

    Product
    Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0247-2023·2023-02-08

    FDA Recalls First Aid Cream Packets Over Bacterial Contamination

    The FDA is recalling Adventure First Aid 1.5 first aid kits due to bacterial contamination found in the included burn cream packets. The contamination was identified through FDA laboratory testing.

    Product
    Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0324-2023·2023-02-08

    Fullei Fresh Alfalfa Sprouts Recalled for Possible E. coli Contamination

    Fullei Fresh brand alfalfa sprouts are recalled due to possible contamination with Shiga toxin-producing E. coli. The recall affects 333 cases distributed in Florida, lot number 336.

    Product
    Fullei Fresh brand Alfalfa Sprouts in a 4 oz. clear plastic clamshell container; UPC Code 17442 30012. Packaged in 5lb carboard box 12 packages of 4 oz
    Category
    Food
    Distribution
    1 state
  • 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 (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-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 (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-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 (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
  • SevereNHTSA·23V054000·2023-02-06

    Nova Bus Recalls 2022 LFS Transit Buses for Steering Hose Defect

    Nova Bus is recalling 2022 LFS transit buses because the power steering hose may not have been assembled correctly, which can result in hose detachment and a loss of power steering assist.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V050000·2023-02-03

    BMW Recalls 2023 760i and i7 Models Due to Airbag Software Defect

    BMW is recalling 397 vehicles because a software error may disable front passenger airbags and active headrests, increasing injury risk in crashes.

    Product
    BMW — BMW 760I, I7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·004-2023·2023-02-03

    USDA Recalls Ineligible Frozen Catfish Imported from India

    Delight Foods USA LLC and Delight Foods LLC are recalling approximately 2,961 pounds of frozen catfish imported from India because the country is ineligible to export these products to the U.S.

    Product
    Delight Foods USA LLC Recalls Ineligible Frozen Siluriformes Products Imported from India
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V047000·2023-02-02

    GM Recalls 2017-2019 Chevrolet and GMC Trucks for Fuel Tank Defect

    General Motors is recalling 2017-2019 Chevrolet Silverado and GMC Sierra trucks because a rear fuel tank may collapse, causing the engine to stall and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SIERRA 3500, SIERRA 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2023·2023-02-01

    Advil Liqui Gels Minis Recalled for Illegible Label Due to Adhesive Migration

    Glaxosmithkline Consumer Healthcare is recalling Advil Liqui Gels (minis) 200mg capsules nationwide due to illegible labeling caused by adhesive migration. Consumers should discard affected product or return it to the retailer.

    Product
    Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0959-2023·2023-02-01

    Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect

    Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.

    Product
    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2023·2023-02-01

    Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation

    The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.

    Product
    Getinge Flow-c Anesthesia System, Part No. 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2023·2023-02-01

    Epinephrine API Recalled for Discoloration and Reduced Efficacy

    Spectrum Laboratory Products recalls Epinephrine (L-Adrenaline) USP in multiple lot sizes due to discoloration that could reduce the product's effectiveness. The recall affects shipments distributed nationwide in the USA, Puerto Rico, and Canada.

    Product
    Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2023·2023-02-01

    Advil Liqui Gels Recalled Due to Illegible Labeling Defect

    Advil Liqui Gels (200mg ibuprofen capsules) are being recalled nationwide because adhesive on the packaging migrated onto the label, causing it to tear and become illegible when peeled back.

    Product
    Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2023·2023-02-01

    Epinephrine Active Pharmaceutical Ingredient Recalled for Discoloration

    Spectrum Laboratory Products is recalling Epinephrine API lot 1KG0865 due to discoloration that may compromise product effectiveness. The product was distributed nationwide in the USA, Puerto Rico, and Canada.

    Product
    Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
    Category
    Drug
    Distribution
    Distributed nationwide