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.

6701–6725 of 29119

  • SevereFDA (Devices)·Z-0999-2022·2022-05-04

    Surgical Stapler: da Vinci SureForm Recalled for Tissue Pushout and Bleeding

    Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.

    Product
    da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1014-2022·2022-05-04

    Red Curry Grain Bowl Recalled for Undeclared Wheat Allergen

    Produce Packaging Inc. is recalling 57 cases of Red Curry Grain Bowls distributed to IL and OH due to undeclared wheat on the product label. The FDA issued a Class I classification for this recall.

    Product
    Produce Packaging Inc. brand Red Curry Grain Bowl in a 10.5oz plastic bowl with a plastic lid. Four bowls per case.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1047-2022·2022-05-04

    Organic Marketside Zucchini Recalled Due to Salmonella Contamination Risk

    World Variety Produce Inc is recalling Organic Marketside Zucchini sold at Walmart due to potential Salmonella contamination. The product was distributed to Walmart distribution centers in 18 states.

    Product
    Organic Marketside Zucchini 2 Count packages/8 per case Ingredients: Organic Zucchini New WT. 6 oz. (170g) UPC: 6-81131-22105-4 Perishable Keep Refrigerated Clear plastic overwrap tray Use within 2-3 days of opening Distributed by Walmart, Inc. Bentonville, AR 72716 Pro
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Food)·F-1015-2022·2022-05-04

    Produce Packaging Spicy Southwest Grain Bowl recalled for undeclared wheat

    Produce Packaging Inc.'s Spicy Southwest Grain Bowl is recalled for failing to declare wheat on the product label. Products were distributed to Illinois and Ohio.

    Product
    Produce Packaging Inc. brand Spicy Southwest Grain Bowl in a 11.75oz plastic bowl with a plastic lid. One bowl per case.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0953-2022·2022-05-04

    Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities

    Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1016-2022·2022-05-04

    Groundwork MIND-FULL Bar Snacks Recalled for Undeclared Allergens

    Groundwork Coffee LLC recalled MIND-FULL Bar snacks distributed in California and Oregon because allergens were not properly declared on the product. The bars contain peanut butter and should not be consumed by those with nut allergies.

    Product
    groundwork MIND-FULL Bar. Ingredients: Gluten-free oats, Flax seed, Chocolate chips, Brown sugar, Chia seeds, peanut butter, salt, cinnamon, coconut oil, agave, vanilla. Vegan, Gluten Free. Contains Nuts 671 Rose Ave. Venice, CA 90291
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0966-2022·2022-05-04

    Ventilator Audible and Visual Alarms May Not Activate During Alarm States

    The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.

    Product
    Puritan Bennett 980 Series Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V295000·2022-05-03

    2022-2023 Mack Granite Trucks Recalled for Insufficient Brake Air Tank Volume

    Mack is recalling 2022-2023 Granite trucks because the air tanks lack sufficient volume for proper brake system operation. Insufficient air can reduce braking performance and increase crash risk. Dealers will install replacement air tanks at no charge.

    Product
    MACK — MACK GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V293000·2022-05-03

    Cruiser Shadow Cruiser Travel Trailer Recall for LP Gas Leak Risk

    Cruiser RV is recalling 2022 Shadow Cruiser travel trailers because cracked LP gas fittings may cause a gas leak, increasing fire risk.

    Product
    CRUISER RV — CRUISER RV SHADOW CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2022·2022-04-29

    Wayne Farms Recalls Undercooked Ready-to-Eat Chicken Breast Fillets

    Wayne Farms is recalling approximately 30,285 pounds of ready-to-eat chicken breast fillets that may be undercooked. The recall was initiated after a customer complaint.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Ready-to-Eat Chicken Breast Fillet Products That May Be Undercooked
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V284000·2022-04-28

    2021 Jeep Grand Cherokee Recalled for Sticking EGR Valve

    Chrysler is recalling 2021 Jeep Grand Cherokee and Dodge Durango vehicles due to EGR valve defects that may cause loss of drive power and increase crash risk. Dealers will provide free replacement.

    Product
    JEEP — JEEP, DODGE GRAND CHEROKEE 4XE, DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V287000·2022-04-28

    Micro Bird Recalls Transit and School Buses for Electrical Fire Risk

    Micro Bird is recalling 2006-2021 transit and school buses because a damaged electrical harness may short circuit and cause a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, G5 SCHOOL BUS, MB II SCHOOL BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1002-2022·2022-04-27

    Fresh-cut Hawaiian blend fruit recalled due to Salmonella

    Carol's Cuts Hawaiian Blend is being recalled due to Salmonella in fresh-cut cantaloupe. The product was distributed to retail stores, military facilities, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Hawaiian Blend Ingredients may include Honeydew, cantaloupe, pineapple, strawberries and blueberries Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 32 oz UPC: 852193321086 Best If Used By: 03/21/22, 03/23/22, 03/24/22, 03/26/22 Product of: USA. CRI
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1008-2022·2022-04-27

    Super Twa Mushroom Mixed Mushrooms Recalled Due to Listeria Monocytogenes

    Farm Fresh Produce LLC is recalling Super Twa Mushroom Mixed Mushrooms (14.11 oz) due to Listeria monocytogenes contamination identified in California. The recall affects 160 cases distributed in California only.

    Product
    Super Twa Mushroom Mixed Mushrooms; New Wt/When Packed) 14.11 oz. (400g) Keep refrigerated. UPC: 6957937481850
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0785-2022·2022-04-27

    FDA Recalls Pink Pussycat Sensual Enhancement Capsules for Undeclared Sildenafil

    Pink Pussycat Sensual Enhancement capsules are being recalled nationwide. The FDA found they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2022·2022-04-27

    artnaturals Hand Sanitizer Recalled for Benzene and Chemical Contamination

    artnaturals ethyl alcohol hand sanitizer (8 fl oz bottles, lot G20127E and G20128A, exp. 5/1/2022) is recalled nationwide due to chemical contamination including benzene, acetaldehyde, and acetal.

    Product
    artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2022·2022-04-27

    Carol's Cuts Fresh-Cut Cantaloupe Fruit Medley Recalled for Salmonella

    Carol's Cuts Fruit Medley is recalled due to fresh-cut cantaloupe testing positive for Salmonella. The affected product was distributed to retail, military, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Fruit Medley Ingredients may include Honey, cantaloupe, pine, and grape Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 8oz, Net Weight 16oz UPC: 852193001087, 852193900458 Best If Used By: 03/21/22, 03/23/22, 03/27/22, 03/26/22, 03/24/22 Product of
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide