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.

11176–11200 of 29159

  • SevereFDA (Devices)·Z-2593-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 5 units of SHERPA NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2567-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0052-2020·2019-10-09

    KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues

    KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.

    Product
    Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2706-2019·2019-10-09

    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 RCBII, .070", REF SA6RCBII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2623-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 1,364 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 AL2.0, .070", REF SA6AL20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2661-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 49 units of the SHERPA NX Active Guiding Catheter because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2690-2019·2019-10-09

    SHERPA NX Active Guiding Catheter recall due to exposed stainless-steel braid wires

    A recall of Medtronic Vascular SHERPA NX active guiding catheters was issued because some units may expose underlying stainless-steel braid wires, posing a potential safety risk.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0118-2020·2019-10-09

    KRS Global Biotechnology Recalls Isoproterenol HCL IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.

    Product
    Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2578-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 17 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, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2688-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 247 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2019·2019-10-09

    Medtronic Recalls 6F Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 4 units of 6F 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, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2718-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 56 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 ERAD LEFT, SHORT TIP, .070", REF SA6ERADLST. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0067-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Epinephrine Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.

    Product
    LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2731-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0009-2020·2019-10-09

    Colonia Care Pharmacy Recalls Dexamethasone Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution because the sterility of the product cannot be guaranteed.

    Product
    C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2642-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 213 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 JL3.5 SH, .070", REF SA6JL35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2574-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Structural Defect

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

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0043-2020·2019-10-09

    FDA Recalls Bimix #3 Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling Bimix #3 vials because the company cannot ensure the product is sterile.

    Product
    Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0054-2020·2019-10-09

    KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2656-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 69 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 EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0010-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-EDETATE DISODIUM 1.5% Ophthalmic Solution

    Colonia Care Pharmacy is recalling specific lots of C-EDETATE DISODIUM 1.5% Ophthalmic Solution because the sterility of the product cannot be guaranteed.

    Product
    C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0068-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee the product is sterile.

    Product
    LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2563-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 658 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, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2669-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 76 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 MP ST, .070", REF SA6MPST. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states