The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

1876–1900 of 7439

  • CriticalFDA (Devices)·Z-2736-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 52 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2596-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2686-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 51 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2751-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2676-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2725-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 16 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2589-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 22 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2691-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2717-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 40 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2627-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 167 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2729-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2564-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 538 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0019-2020·2019-10-09

    SE Grocers Bakery Variety Pack Cookies Recalled for Undeclared Peanut

    Southeastern Grocers is recalling 18-count Variety Pack Cookies made in-store because peanut butter cookies were included without declaring peanuts on the label.

    Product
    SE Grocers **BAKERY** 18 CT Variety Pack Cookies
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-2618-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 15,603 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0036-2020·2019-10-02

    Natpara Injection Cartridges Recalled for Potential Needle Clogging

    Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0038-2020·2019-10-02

    Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing

    Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.

    Product
    Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Food)·F-2249-2019·2019-10-02

    Whole Foods Recalls Red Apple Cookies Due to Undeclared Egg

    Whole Foods Market is recalling 4,880 decorated red apple cookies because they contain undeclared egg. The cookies were sold in Arizona, Southern California, Hawaii, and southern Nevada.

    Product
    Decorated Red Apple Cookies sold in display case in retail stores
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0125-2020·2019-10-02

    FDA Recalls Quinacrine Dihydrochloride Bulk API Due to Labeling Error

    Darmerica, LLC is recalling 1.8 kilograms of bulk Quinacrine Dihydrochloride API because testing revealed the product was actually Artemisinin.

    Product
    Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2197-2019·2019-09-25

    PitaPal Texas Spicy Hummus Recalled for Listeria Contamination Risk

    Pita Pal Foods LP is recalling PitaPal Texas Spicy Hummus due to potential Listeria monocytogenes contamination. The recall covers 10 oz. and 5 lb. packages distributed nationwide.

    Product
    PitaPal Texas Spicy Hummus 10 oz. UPC 851570003614 packaged in Plastic tub with clear lid with green rim; PitaPal Texas Spicy Hummus 5 lbs. UPC 85015700089 3 packaged in White plastic tub with white lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2192-2019·2019-09-25

    PitaPal Mezza Sundried Tomato Hummus Recalled for Listeria Risk

    Pita Pal Foods LP is recalling 24 cases of PitaPal Mezza Sundried Tomato Hummus due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Mezza Sundried Tomato Hummus 11 oz. UPC 851351007336 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2184-2019·2019-09-25

    Lidl Hummus Quartet Recalled for Potential Listeria Contamination

    Pita Pal Foods LP is recalling Lidl Hummus Quartet 16 oz. due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Lidl Hummus Quartet 16 oz. UPC 4334035782713 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2213-2019·2019-09-25

    Pita Pal Foods Recalls Hummus Due to Listeria Risk

    Pita Pal Foods LP is recalling Reasor's Roasted Garlic Hummus because it may be contaminated with Listeria monocytogenes. The product was distributed nationwide.

    Product
    Reasor's Roasted Garlic Hummus 10 oz. UPC 78767 00068 packaged in Plastic tub with clear lid with black rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2203-2019·2019-09-25

    PitaPal Organic Roasted Red Pepper Hummus Recalled for Listeria Risk

    Pita Pal Foods LP is recalling 17 oz. tubs of Organic Roasted Red Pepper Hummus due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Organic Roasted Red Pepper Hummus 17 oz. UPC 851570003096 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2190-2019·2019-09-25

    PitaPal Organic Roasted Garlic Hummus Recalled for Listeria Risk

    Pita Pal Foods LP is recalling PitaPal Organic Roasted Garlic Hummus due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Organic Roasted Garlic Hummus 10 oz UPC 851570003508 and 17 oz. UPC 851570003089 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2198-2019·2019-09-25

    PitaPal Mezza 4 Bean Hummus Recalled for Listeria Risk

    Pita Pal Foods LP is recalling 74 cases of PitaPal Mezza 4 Bean Hummus 11 oz. due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Mezza 4 Bean Hummus 11 oz. UPC 851351007312 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide