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.

3451–3475 of 29102

  • SevereFDA (Food)·F-1030-2024·2024-03-13

    Chicken Enchilada Recall: Listeria Risk from Queso Fresno Cheese

    The Fierro Group Inc. (Rico Brands) is recalling Chicken Enchilada with Mole Rice & Beans due to potential Listeria monocytogenes contamination in the Queso Fresno cheese. Affected products were distributed to supermarkets in Utah.

    Product
    Chicken Enchilada with Mole Rice & Beans 14 oz. packaged in a in a Deep Meal tray with Plant Fiber - Film 800.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1038-2024·2024-03-13

    Castle Importing Cotija Cheese Recalled for Potential Listeria Contamination

    Castle Importing is recalling crumbled and grated Cotija cheese due to potential Listeria monocytogenes contamination. The affected products were distributed to retailers in California, Ohio, Connecticut, Florida, Texas, Washington, and Illinois.

    Product
    Crumbled Cotija Net Wt. 5.6 lbs (300/0.3oz), Net Wt. 7.5 lbs (300/0.4 oz) Fontana, CA 92336 Plant #06-00333 Classic Castle Brand Crumbled Cotija Net Wt. 20 lbs, Net Wt. 5 lbs Fontana, CA 92336 Plant #06-00333 Classic Castle Brand Grated Cotija Net Wt. 20 lbs, Net Wt. 5 lbs Font
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1040-2024·2024-03-13

    Chick-fil-A Polynesian Sauce Cup recalled for undeclared wheat and soy allergens

    T Marzetti Co is recalling Chick-fil-A Polynesian Sauce Cups (28g single serve) due to undeclared wheat and soy allergens. The product was distributed across 11 U.S. states.

    Product
    Chick-fil-a Polynesian Sauce Cup: 28g single serve food service cup
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·24V194000·2024-03-12

    E-One Recalls 2024 Commercial and Cyclone N Vehicles for Electrical Fire Risk

    E-One is recalling 22 model-year 2024 vehicles equipped with specific multiplex nodes due to a firmware defect that can cause electrical circuits to overheat and increase fire risk.

    Product
    E-ONE — E-ONE CYCLONE N, TYPHOON, TYPHOON N, COMMERCIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2024·2024-03-07

    Johnsonville Turkey Kielbasa Recalled for Rubber Contamination

    Salm Partners is recalling Johnsonville Polish Kielbasa Turkey Sausage due to possible rubber contamination. No injuries have been reported.

    Product
    Salm Partners, LLC — Salm Partners, LLC, Recalls Johnsonville Polish Kielbasa Turkey Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V181000·2024-03-07

    Spartan Fire Recalls 2023-2024 Fire Trucks Due to Electrical Fire Risk

    Spartan Fire is recalling 2023-2024 Gladiator, MetroStar, and other fire trucks because a firmware defect can cause electrical circuits to overheat and increase fire risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME METROSTAR, redundant PANTHER, GLADIATOR, FC-94
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1057-2024·2024-03-06

    AirLife Adult Manual Resuscitator units recalled for component failure

    Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1003-2024·2024-03-06

    Rojo Black Bean 6 Layer Dip Recalled for Potential Listeria Contamination

    Lakeview Farms LLC is recalling Rojo Black Bean 6 Layer Dip due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard or return it.

    Product
    Rojo Black Bean 6 Layer Dip packaged in 20oz PET plastic containers, sold in sleeve with two containers per sleeve. 12 sleeves per case.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1096-2024·2024-03-06

    Medline Medical Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1135-2024·2024-03-06

    Medline recalls Centurion Laceration Trays for potential sterility defect

    Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2024·2024-03-06

    Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk

    Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.

    Product
    MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2024·2024-03-06

    Medline Prep Kits Recalled Due to Non-Sterile Components

    Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1106-2024·2024-03-06

    MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure

    MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2024·2024-03-06

    Medline Tracheal Care Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.

    Product
    MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1063-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for ventilation failure risk

    Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1165-2024·2024-03-06

    Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk

    Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1092-2024·2024-03-06

    MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure

    MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2024·2024-03-06

    Medline Tracheostomy Care Trays Recalled for Sterility Issues

    Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.

    Product
    Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1130-2024·2024-03-06

    Medline Centurion dialysis kits recalled due to sterility concerns

    Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2024·2024-03-06

    Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions

    Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1162-2024·2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1014-2024·2024-03-06

    Sargento White Cheddar Cheese Recalled for Listeria Monocytogenes

    Sargento Foods is recalling White Cheddar cheese products due to Listeria monocytogenes. The affected products were distributed in 15 states; consumers should discard them.

    Product
    White Cheddar cheese packaged in the following configurations: 1. Sargento Part #23340 Fancy Shredded Sharp White Cheddar Cheese. Pack Size 500/0.5 oz. Material #10001126, UPC 46100329313. 2. Sargento Fancy Shredded Mild White Cheddar Cheese. Pack Size 500/0.5 oz. Ne
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1138-2024·2024-03-06

    Medline circumcision surgical kits recalled for sterility concerns

    Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
    Category
    Medical Device
    Distribution
    Distributed nationwide