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.

3226–3250 of 29099

  • SevereFDA (Devices)·Z-1652-2024·2024-05-22

    Cardiac Catheters Recalled Due to Delamination and Device Malfunction

    Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1682-2024·2024-05-22

    Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Malfunction

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in eight batches affecting 4942 units. The defect prevents guidewire advancement and could compromise device function during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1683-2024·2024-05-22

    Boston Scientific cardiac catheters recalled for polyurethane delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. Approximately 37,252 catheters in specific batches are affected worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1648-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters recalled for delamination risk

    Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in select batches due to polyurethane layer delamination and material detachment that could prevent guidewire advancement during use.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1661-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment

    Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1668-2024·2024-05-22

    Boston Scientific Expo 5F Cardiac Catheters Recalled for Delamination Defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement during cardiac procedures. The recall affects 86,898 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1646-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Inner Lining Material Failure

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter's inner lining. This prevents guidewire advancement through the catheter.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·24E038000·2024-05-21

    Cummins Recalls L9 Diesel Engines Due to Fuel Hose Separation Risk

    Cummins is recalling L9 diesel engines because remote fuel filter hoses may separate, causing fuel leaks, fire risks, or engine stalls.

    Product
    FUEL SYSTEM, DIESEL:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V356000·2024-05-21

    Turtle Top Recalls 2024 Vehicles Due to Seat Recliner Defect

    Turtle Top is recalling 2024 Van Terra, Terra Transit, Odyssey, and Odyssey XL vehicles because the seat recliner mechanism may not engage, increasing injury risk in a crash.

    Product
    TURTLE TOP — TURTLE TOP TERRA TRANSIT, ODYSSEY, VAN TERRA, ODYSSEY XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V358000·2024-05-21

    Kia Recalls 2022 Niro EV Vehicles Due to Battery Fire Risk

    Kia is recalling 2022 Niro EV vehicles because a high-voltage battery safety plug may overheat and melt, potentially causing a fire or loss of drive power.

    Product
    KIA — KIA NIRO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24235·2024-05-16

    Electrolux Frigidaire and Kenmore Electric Ranges Recalled for Fire and Burn Hazards

    Electrolux is recalling about 203,000 Frigidaire and Kenmore smooth-top electric ranges because heating elements can turn on unexpectedly, fail to turn off, or heat incorrectly, posing fire and burn risks. At least 212 incidents have been reported since 2009, including 14 fires and 8 burn injuries.

    Product
    Frigidaire and Kenmore Smooth-top Freestanding Electric Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1609-2024·2024-05-15

    Insulin pump app may crash and drain battery, risking insulin delivery interruption

    Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.

    Product
    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0486-2024·2024-05-15

    Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency

    Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1230-2024·2024-05-15

    Vanilla Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies is recalling Vanilla Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts.

    Product
    Vanilla Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1234-2024·2024-05-15

    Key Lime Ice Cream Cookie Sandwiches Recalled for Undeclared Allergens

    Belgian Yummies is recalling Key Lime Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, soy, wheat, peanuts, and tree nuts. Consumers with these allergies should not consume the product.

    Product
    Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1236-2024·2024-05-15

    Belgian Yummies ice cream recalled for undeclared milk and wheat

    Belgian Yummies Homemade Ice Cream Horchata Gelato distributed in Florida is recalled due to undeclared milk and wheat allergens that may affect consumers with allergies.

    Product
    Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1733-2024·2024-05-15

    Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events

    Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.

    Product
    BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Mark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V343000·2024-05-15

    Porsche Recalls 2024 718 Models Due to Shift Cable Installation Issue

    Porsche is recalling 2024 718 Cayman and Boxster vehicles because a safety clip may not be installed properly, potentially preventing the transmission from locking in park.

    Product
    PORSCHE — PORSCHE 718 CAYMAN, 718 BOXSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V342000·2024-05-15

    Morbark Brush Chippers Recalled for Fuel Line Fire Risk

    Alamo Group is recalling 2023-2024 Morbark brush chippers because fuel lines may lack the required pressure rating, creating a fire hazard.

    Product
    MORBARK — MORBARK EEGER BEEVER 1922, EEGER BEEVER 2131, EEGER BEEVER 1821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V341000·2024-05-15

    Navistar Recalls 2024-2025 IC Bus School Buses for Brake Defect

    Navistar is recalling 2024-2025 IC Bus school buses because a faulty valve module may cause park brake failure or unexpected engagement.

    Product
    IC BUS — IC BUS CESB, CE SBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V345000·2024-05-15

    BMW 2024-2025 X5, X6, X7, XM, and Alpina XB7 Seat Belt Detection System Defect

    BMW recalls certain 2024-2025 X5, X6, X7, XM, and Alpina XB7 models due to a seat belt detection system defect that may fail to alert drivers of unbuckled passengers or allow proper deployment of the supplemental restraint system.

    Product
    BMW — BMW ALPINA XB7, X6, XM, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1233-2024·2024-05-15

    Belgian Yummies Salted Caramel Ice Cream Cookie Sandwiches recalled for undeclared allergens

    Belgian Yummies is recalling Salted Caramel Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, soy, wheat, peanuts, and tree nuts. The recall affects 254 units.

    Product
    Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1776-2024·2024-05-15

    Stealth S8 neurosurgical navigation software display error affecting surgical guidance

    Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

    Product
    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1232-2024·2024-05-15

    Raspberry Ice Cream Cookie Sandwich Recalled for Undeclared Allergens

    Belgian Yummies is recalling Raspberry Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume these products.

    Product
    Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    1 state