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.

2001–2025 of 29084

  • SevereFDA (Food)·F-0723-2025·2025-04-30

    Zaarah Herbals Vasaka Powder Recalled for Elevated Lead Content

    Zaarah Herbals brand Vasaka Powder is recalled due to elevated lead levels of 6.504 ppm. The product was distributed in New York, Connecticut, New Jersey, and California.

    Product
    Zaarah Herbals brand Vasaka Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99967 0
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1585-2025·2025-04-30

    Novasight Hybrid Catheter Recalled for Potential Sheath Detachment

    Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.

    Product
    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-0722-2025·2025-04-30

    Zaarah Herbals Gurmar Powder recalled for elevated lead levels

    Zaarah Herbals brand Gurmar Powder is being recalled due to elevated lead levels. The product was distributed in New York, Connecticut, New Jersey, and California.

    Product
    Zaarah Herbals brand Gurmar Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99969 4
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0374-2025·2025-04-30

    Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk

    Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.

    Product
    Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0372-2025·2025-04-30

    PHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility

    Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl 0.5 mg per 5mL single-dose syringes because some syringes may be leaking or damaged, which could compromise sterility assurance.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2025·2025-04-30

    Amplatzer TorqVue LP Delivery System Recall for Shaft Breach

    Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·013-2025·2025-04-29

    Smith Packing Recalls Sausage and Sliced Meat Due to High Sodium Nitrite Levels

    Smith Packing, LLC is recalling approximately 18,792 pounds of ready-to-eat sausage and sliced meat and poultry products due to sodium nitrite levels exceeding regulatory limits.

    Product
    Smith Packing, LLC — Smith Packing, LLC Recalls Sausage and Sliced Meat and Poultry Products Due to Sodium Nitrite Levels in Excess of Regulatory Limit
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·25V279000·2025-04-29

    Temsa Recalls TS30, TS35, and TS45 Buses Due to Brake Overheating Risk

    Temsa is recalling 2021-2026 TS30, TS35, and TS45 buses because a temporary bus stop valve may activate unintentionally, causing brakes to overheat and increasing fire risk.

    Product
    TEMSA — TEMSA TS45, TS35, TS30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E030000·2025-04-28

    Joyson Curtain Air Bag Inflator Recall for Rupture Risk

    Key Safety Systems (Joyson) is recalling side curtain air bag inflators that may rupture due to a manufacturing defect, potentially causing injury to occupants.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V217000·2025-04-28

    Isuzu Recalls 2025 NRR EV Trucks Due to Cooling Pump Failure Risk

    Isuzu is recalling 73 2025 NRR EV trucks because incompatible coolants may cause the cooling pump to fail, potentially leading to a loss of drive power and increased crash risk.

    Product
    ISUZU — ISUZU NRR EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V278000·2025-04-25

    Forest River Bus Recalls Transit Buses Due to Wiring Fire Risk

    Forest River Bus is recalling 453 transit buses because an incorrectly connected entry door ground wire may increase the risk of a fire.

    Product
    GLAVAL BUS — GLAVAL BUS, FOREST RIVER BUS UNIVERSAL, CHAMPION BUS, GLAVAL ENTOURAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E029000·2025-04-25

    Zoox Recalls Robotaxis Due to Software Crash Risk

    Zoox is recalling 2024 robotaxis because a software defect may cause the vehicle to fail to avoid a crash when another vehicle stops perpendicularly.

    Product
    ZOOX — ZOOX ZOOX ROBOTAXI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V275000·2025-04-24

    2025 Can-Am Origin and Pulse Electric Motorcycle Battery Recall

    NHTSA is recalling 2025 Can-Am Origin and Pulse electric motorcycles because a faulty breather valve may allow water into the battery, risking fire or loss of power.

    Product
    CAN-AM — CAN-AM ORIGIN, PULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V274000·2025-04-24

    GM 6.2L V8 connecting rods and crankshafts may have manufacturing defects

    General Motors is recalling certain 2021-2024 Escalade, Silverado 1500, Suburban, Tahoe, Sierra 1500, Yukon and Yukon XL vehicles with 6.2L V8 engines because connecting rod or crankshaft defects can cause engine failure.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SILVERADO 1500, ESCALADE ESV, ESCALADE, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25232·2025-04-24

    LED Strip Lights Recalled for Coin Battery Ingestion Hazard

    AliExpress-sold RGB LED strip lights are recalled because children can easily access the coin batteries inside, creating a serious ingestion hazard. Swallowed batteries can cause severe internal burns and death.

    Product
    LED Strip Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2025·2025-04-24

    ACC Central Kitchen Recalls Pork Bun Products Due to Undeclared Sesame

    ACC Central Kitchen LLC is recalling approximately 64,008 pounds of pork bun products because they contain sesame, an undeclared allergen. The products were shipped to retail locations in New York.

    Product
    ACC Central Kitchen LLC — ACC Central Kitchen LLC Recalls Pork Bun Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1520-2025·2025-04-23

    Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery

    Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.

    Product
    Tandem Mobi Insulin Pump with Interoperable Technology
    Category
    Medical Device
    Distribution
    29 states
  • SevereNHTSA·25V272000·2025-04-23

    Ford Recalls 2022-2023 F-150 Lightning Vehicles Due to Battery Fire Risk

    Ford is recalling 2022-2023 F-150 Lightning vehicles because loose battery fasteners may cause electrical arcing, increasing the risk of fire or loss of drive power.

    Product
    FORD — FORD F-150 LIGHTNING BEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1526-2025·2025-04-23

    Ballard Closed Suction Catheters recalled due to sterility assurance failure

    Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1524-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for sterility assurance failure

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The recall affects 9,020 units distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2025·2025-04-23

    HeartMate Mobile Power Unit electrical malfunction may cause loss of power

    Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.

    Product
    HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1522-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1527-2025·2025-04-23

    Ballard Closed Suction Catheters lack sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 units distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide