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.

20526–20550 of 32121

  • SevereFDA (Devices)·Z-1055-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1035-2016·2016-03-16

    Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering

    Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.

    Product
    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0738-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling specific hydromorphone, baclofen, and bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V155000·2016-03-16

    Winnebago Recalls 2015-2016 RVs for Improperly Torqued Hitch Bolts

    Winnebago is recalling certain 2015-2016 Adventurer and Itasca Suncruiser vehicles because hitch bolts were not properly torqued, which could cause the hitch to detach and increase crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA ADVENTURER, SUNCRUISER, COMMERCIAL VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0755-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/Clonidine HCL 450 mcg/ml syringes due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0750-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 25 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0764-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0738-2016·2016-03-16

    Brett Anthony Foods Recalls Tofu Curry Cous Cous Salad for Undeclared Allergens

    Brett Anthony Foods is recalling Tofu Curry Cous Cous Salad because the label fails to declare peanuts, soy, and eggs.

    Product
    Tofu Curry Cous Cous Salad packaged in a clear plastic 16 oz box with a white and green label with black lettering.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0757-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling specific syringes of Hydromorphone and Bupivacaine due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0761-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Sufentanil and Clonidine Syringes

    Hartley Medical Center Pharmacy is recalling specific syringes of Sufentanil Citrate and Clonidine HCL due to a lack of assurance of sterility.

    Product
    Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2016·2016-03-16

    Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0759-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate 11 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0911-2016·2016-03-16

    Abbott Vascular Recalls MitraClip Clip Delivery System Due to Mandrel Fracture

    Abbott Vascular is recalling the MitraClip Clip Delivery System because a mandrel fracture may prevent the clip from detaching during implantation.

    Product
    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Baclofen Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and baclofen syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2016·2016-03-16

    Morphine Sulfate Syringes Recalled for Lack of Sterility Assurance

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate 0.5 mg/ml syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0746-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0751-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Fentanyl Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and fentanyl syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0727-2016·2016-03-16

    Picnic Gourmet Red Pepper Feta Cheese Spread Recalled for Listeria

    Picnic Gourmet Spreads LLC is recalling Red Pepper Feta Cheese Spread after testing revealed the presence of Listeria monocytogenes.

    Product
    Picnic Gourmet Spreads ( Red Pepper Feta Cheese Spread) 8 oz containers .12 Containers per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0737-2016·2016-03-16

    Kroger Recalls King Soopers Gourmet Bread Pudding for Undeclared Walnuts

    The Kroger Co is recalling King Soopers City Market Gourmet Bread Pudding due to undeclared walnuts. The product was distributed in Colorado and Utah.

    Product
    King Soopers City Market GOURMET BREAD PUDDING; Various Sizes, INGREDIENTS: HALF & HALF***APPLES, LIQUID EGG***SPICES, SALT***RAISINS, CINNAMON. CONTAINS EGG, MILK, SOY, WHEAT; UPC 2 47460 0XXXX
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0744-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL syringes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide