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.

776–800 of 4878

  • SevereFDA (Food)·F-1485-2024·2024-07-24

    Terrafina raw macadamia nuts recalled for salmonella contamination

    Terrafina macadamia nuts are being recalled because they tested positive for salmonella. The product was distributed in New Jersey and New York.

    Product
    Terrafina, Macadamia in the Raw , Net Wt. 6oz , (170 g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1478-2024·2024-07-24

    Power Greens Products Recalled Due to Listeria monocytogenes Contamination Risk

    Solata Food LLC is recalling multiple Power Greens products due to potential Listeria monocytogenes contamination. Affected products were distributed in NY, NJ, and NH with expiration dates of 6/20/24 and 6/24/24.

    Product
    1. Greens Full Circle Organic Power Greens; 6x10 Clamshell; UPC: 036800490550 / 2. Greens Gaia Organic Power Greens; 8x45 clamshell; UPC: 850021494889 / 3. Greens Full Circle Organic Power Greens; 8x5 clamshell; UPC: 036800388758 / 4. Greens Solata Power Greens; 8x5 Clamshell; U
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1480-2024·2024-07-24

    Greens Farmer Direct Organic Chopped Kale Spinach recalled for Listeria contamination

    Solata Food LLC is recalling Greens Farmer Direct Organic Chopped Kale Spinach due to potential Listeria monocytogenes contamination. The product may pose a serious health risk.

    Product
    1. Greens Farmer Direct Organic Chopped Kale Spinach; 6x9 bag; UPC: 854311007377 /
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1493-2024·2024-07-24

    Aahu Barah Apricot Roll recalled for undeclared elevated sulfites

    Aahu Barah Apricot Roll (14 oz, UPC 882475000279) is being recalled because it contains elevated levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    Aahu Barah Apricot Roll; 14 oz; sold in clear plastic bags (6 inch x 8 inch) packing with the Aaha Barah label on the front and back; the product is labeled "Apricot Roll" on both the front and back; UPC 882475000279; label states "May Contain Sulfites As preservatives"
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2322-2024·2024-07-24

    Volara System Blue Ventilator Adapter Module Handset Plug Disconnection

    Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.

    Product
    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1476-2024·2024-07-24

    Multiple Spinach Products Recalled for Potential Listeria Contamination

    Multiple spinach products from various brands are being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in New York, New Jersey, and New Hampshire.

    Product
    1. Greens Solata Spinach; 10x9 bag; UPC: 854311007391 / 2. Greens Full Circle Organic Baby Spinach; 6x10 Clamshell; UPC: 036800490512 / 3. Greens Solata Baby Spinach 6x10 clamshell; UPC: 85002149475 / 4. Greens Gaia Organic Baby Spinach 6x10 clamshell; UPC: 850021494837 / 5. Gre
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1479-2024·2024-07-24

    Greens products recalled for potential Listeria monocytogenes contamination

    Solata Food LLC is recalling multiple brands of greens products distributed in NY, NJ, and NH due to potential Listeria monocytogenes contamination. Affected products, totaling 4,382 lbs with expiration dates of June 20–24, 2024, should not be consumed.

    Product
    1. Greens Solata 5050; 6x10 clamshell; UPC: 850021494766 / 2. Greens Gaia Organic 5050; 6x10 clamshell; UPC: 850021494827 / 3. Greens Gaia Organic 50/50 blend; 8x45 clamshell; UPC: 850021494919 / 4. Greens Gaia Organic 50/50; 8x45 clamshell; UPC: 850021494957 / 5. Greens Full Ci
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·24307·2024-07-18

    CFMOTO ZFORCE 950 ROVs Recalled for Crash and Tip-Over Hazards

    CFMOTO is recalling approximately 3,630 ZFORCE 950 HO Sport Side-by-Side recreational off-highway vehicles from 2022–2023 because the shock absorber rod assembly can unthread and detach, causing suspension collapse and crash or tip-over hazards.

    Product
    CFMOTO ZFORCE 950 HO Sport Side-by-Side ROVs (2022-2023)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1463-2024·2024-07-17

    Powdered infant formula recalled for missing safety evaluation

    Farmalac powdered infant formula was recalled because the manufacturer failed to submit required premarket notification to the FDA. The product was never evaluated for safety or nutritional standards.

    Product
    Farmalac powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2314-2024·2024-07-17

    Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries

    Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.

    Product
    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2315-2024·2024-07-17

    Baxter iLED 7 surgical lights recalled due to thermal burn risk

    Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.

    Product
    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2254-2024·2024-07-17

    Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates

    Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1468-2024·2024-07-17

    7-Eleven Simply Egg Salad Sandwich recalled due to undeclared milk allergen

    Taylor Farms Northwest LLC has voluntarily recalled 7-Eleven Simply Egg Salad Sandwich (6.8 oz) due to undeclared milk, affecting products distributed in Oregon and Washington.

    Product
    7-Eleven Simply Egg Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.8oz (193g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0588-2024·2024-07-17

    OTC Sunscreen Foundation Recalled for Fungal Mold Contamination

    Suntegrity IMPECCABLE SKIN sunscreen foundation is recalled for microbial contamination with Aspergillus Sydowii mold. Consumers should discontinue use immediately.

    Product
    IMPECCABLE SKIN - IVORY — IMPECCABLE SKIN - IVORY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1466-2024·2024-07-17

    Queso Rico La Hacienda Queso Fresco Cheese Recalled for Listeria

    Queso Rico La Hacienda brand queso fresco cheese was found to contain Listeria monocytogenes. FDA Class I recall affects 640 pounds distributed to retail stores in Texas counties.

    Product
    Queso Rico La Hacienda brand queso fresco cheese packaged in 9 oz, 1 pound, and 2 pound plastic packages. Product labeling reads in part "***QUESO RICO LA HACIENDA***EL QUESO FRESCO FRESCO DE VERACRUZ***Lic. Permit #483709 El Queso Rico "LA HACIENDA"***5617 E. Trenton Rd., Suite
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2253-2024·2024-07-17

    BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure

    FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2024·2024-07-17

    7-Eleven Chicken Salad Sandwich Recalled for Undeclared Milk Allergen

    Taylor Farms Northwest recalled 7-Eleven Simply Chicken Salad Sandwiches for containing undeclared milk. The Class I recall affects 319 units distributed in Oregon and Washington.

    Product
    7-Eleven Simply Chicken Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.6oz (187g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1472-2024·2024-07-17

    Arepas La Mejor Arepa de Chocolo Recalled for Undeclared Milk Allergen

    Villa Nueva Interservices is recalling Arepas La Mejor Arepa de Chocolo due to undeclared milk allergen. Consumers with milk allergies are at risk.

    Product
    Arepas La Mejor, Arepa de Chocolo (Chocolate Sweet Corn Pancakes), NET WT. 25 Oz., 5 units per package, KEEP REFRIGERATED
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2313-2024·2024-07-17

    Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk

    Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.

    Product
    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1465-2024·2024-07-17

    Infant Formula Recalled for Lack of Premarket Safety Evaluation

    Farmalac 0-12 Low lactose powdered infant formula is being recalled because the manufacturer did not submit required premarket notification to the FDA. The product has not been evaluated against U.S. food safety and nutritional standards.

    Product
    Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1473-2024·2024-07-17

    Leona's Ice Cream Sandwiches Recalled for Peanut Cross-Contamination

    Leona's Strawberry Pretzel Salad ice cream sandwiches are recalled due to peanut cross-contamination. The product was distributed in Pennsylvania.

    Product
    Leona's Ice Cream , Strawberry Pretzel Salad, Individually wrapped, 6 oz. sandwich
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2251-2024·2024-07-17

    Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization

    Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide