The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

14176–14200 of 29192

  • SevereFDA (Devices)·Z-2159-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recalled for De-airing Plug Breakage Risk

    Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

    Product
    Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2188-2018·2018-06-20

    Angiodynamics Recalls XCELA PASV Nitinol Wire Kits Due to Endotoxin Risk

    Angiodynamics Inc. is recalling 7 boxes of XCELA PASV 5F SL 55CM IR-145 Nitinol Wire Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2146-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 1,742 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·18E042000·2018-06-19

    Bosch High Pressure Fuel Pump Recall for Fire Risk

    Bosch is recalling high pressure fuel pump assemblies for Ford and GM vehicles because welds may fracture, causing a fuel leak that could lead to a fire.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V410000·2018-06-15

    2017-2018 Thomas Built Buses Saf-T-Liner EFX Air Brake Recall

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner EFX transit buses due to a check valve defect that may cause sudden parking brake activation and increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E041000·2018-06-15

    Simard Suspensions Recalls Front Axles Due to Wheel Detachment Risk

    Simard Suspensions is recalling certain front suspensions because heat from brakes may melt plastic insulators, causing wheels to detach and increasing crash risk.

    Product
    WHEELS:HUB recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V407000·2018-06-15

    Mercedes-Benz Recalls 2018 S-Class Vehicles for Electrical Fire Risk

    Mercedes-Benz is recalling 2018 S-Class and Maybach vehicles because improperly secured electrical power bars in the trunk may increase the risk of a fire or loss of vehicle functions.

    Product
    MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 560 4MATIC, S 650, S 450, S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V411000·2018-06-15

    Freightliner Recalls 2018-2019 Cascadia Trucks Due to Brake Caliper Bolt Issue

    Daimler Trucks North America is recalling 2018-2019 Freightliner Cascadia vehicles because brake caliper mounting bolts may not be properly tightened, potentially leading to reduced braking performance.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V409000·2018-06-15

    Thomas Built Buses Recalls Saf-T-Liner EFX School Buses for Brake Defect

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner EFX school buses because an incorrectly plumbed check valve may cause sudden parking brake activation and increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E040000·2018-06-14

    Dexter Ventline Recalls LP Bottle Straps for Insufficient Crimping

    Dexter Ventline is recalling specific LP bottle straps because insufficient crimping may allow the buckle to detach. This could cause the propane tank to fall from the trailer, creating a road hazard.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V397000·2018-06-14

    General Motors Recalls 2013 Chevrolet Volt for Propulsion Loss Risk

    General Motors is recalling 2013 Chevrolet Volt vehicles because a software update may disable cell balancing, causing a low-voltage condition that could lead to a loss of propulsion and increased crash risk.

    Product
    CHEVROLET — CHEVROLET VOLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2118-2018·2018-06-13

    Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0906-2018·2018-06-13

    Hospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter

    Hospira is recalling Naloxone Hydrochloride Injection cartridges due to the presence of particulate matter on the syringe plunger.

    Product
    NALOXONE HYDROCHLORIDE — NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2126-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1538-2018·2018-06-13

    KUIYI International Recalls XZB Grilled Crispy Shrimp for Nitrofurans

    KUIYI International Inc. is recalling XZB Grilled Crispy Shrimp because the product tested positive for nitrofurans. The recall affects 399 cartons distributed in California.

    Product
    XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2131-2018·2018-06-13

    Orthofix Recalls MTP Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

    Product
    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2132-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2135-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to engage plates during surgery.

    Product
    Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2134-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
    Category
    Medical Device
    Distribution
    19 states