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.

11251–11275 of 29159

  • SevereFDA (Drugs)·D-0005-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a lack of assurance of sterility.

    Product
    C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0111-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2750-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 80 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 JL3.5, .070", REF SA6JL355. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2599-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 20 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, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2687-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0092-2020·2019-10-09

    KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns

    KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.

    Product
    Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0096-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.

    Product
    Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution because the product's sterility cannot be guaranteed.

    Product
    C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2615-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 6F 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 EBU3.75, .070", REF SA6EBU375. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0084-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection

    KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2652-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 237 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, .070", REF SA6JL45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2694-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 48 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2583-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 555 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, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0098-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2624-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3,302 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 AL1.0, .070", REF SA6AL10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2683-2019·2019-10-09

    Medtronic Recalls 14 Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0104-2020·2019-10-09

    FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.

    Product
    SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2747-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 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 EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19V716000·2019-10-08

    2019 Mercedes-Benz and Freightliner Sprinter Door Component Recall

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because an incorrectly installed door component may make doors harder to open after a severe frontal crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 2500, SPRINTER 4500, SPRINTER 3500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V715000·2019-10-08

    Mercedes-Benz Recalls Metris Vans Due to Exposed Battery Fire Risk

    Daimler Vans USA is recalling 2016-2019 Mercedes-Benz Metris vehicles because the backup battery compartment may lack a cover, creating a fire hazard if conductive material contacts the terminals.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V707000·2019-10-04

    Blue Bird Recalls School Buses Due to Insufficient Roof Rivets

    Blue Bird is recalling 2019-2021 school buses because insufficient roof rivets may allow roof sheets to separate in a crash, increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN SCHOOL BUS, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V708000·2019-10-04

    Outdoors RV Recalls Trail Series Trailers Due to Axle Mounting Defect

    Outdoors RV is recalling 2019-2020 Trail Series MTN TRX 22TRX toyhauler travel trailers because incorrectly mounted axles may cause unsafe towing conditions.

    Product
    OUTDOORS RV — OUTDOORS RV TRAIL SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide