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.

27776–27800 of 32242

  • SevereNHTSA·13V336000·2013-08-01

    Subaru Recalls 2013-2014 Models for Automatic Transmission Parking Rod Defect

    Subaru is recalling specific 2013 Tribeca and 2014 Legacy/Outback vehicles because a parking rod may detach, preventing the vehicle from being moved or allowing it to roll away.

    Product
    SUBARU — SUBARU TRIBECA, LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1766-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Blood Leakage

    LeMaitre Vascular is recalling AlboGraft Woven with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1767-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding

    LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood blushing or leaking from the surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1754-2013·2013-07-31

    LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage

    LeMaitre Vascular is recalling specific AlboGraft vascular grafts because blood may blush or leak from the surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1755-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding

    LeMaitre Vascular is recalling specific AlboGraft Vascular Grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1764-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding

    LeMaitre Vascular is recalling AlboGraft Knitted with Collagen grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1760-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding

    LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1763-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding

    LeMaitre Vascular is recalling two units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-825-2013·2013-07-31

    West-Ward Recalls Belladonna Alkaloids Tablets Due to Cross-Contamination

    West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because they contain a trace amount of Methocarbamol.

    Product
    West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-813-2013·2013-07-31

    Hospira Recalls Sodium Chloride Injection Vials Due to Particulate Matter

    Hospira is recalling 268,700 vials of Sodium Chloride Injection, USP, 0.9% due to a confirmed report of visible particulate matter embedded in the plastic vial.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1769-2013·2013-07-31

    LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leaking

    LeMaitre Vascular is recalling two units of AlboGraft Woven with Collagen vascular grafts because blood may leak from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1758-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking

    LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.

    Product
    AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1759-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding

    LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 20x10 (Lot 56890A) due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1733-2013·2013-07-31

    Hearthside Recalls Salted Pistachios Due to Vendor FDA Class 2 Recall

    Hearthside Food Solutions LLC is recalling salted pistachios in the shell because a vendor, ARO Pistachio Inc., issued an FDA Class 2 voluntary recall.

    Product
    Pistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-811-2013·2013-07-31

    Med Prep Consulting Recalls Compounded Products Due to Sterility Concerns

    Med Prep Consulting, Inc. is recalling all compounded products due to a lack of assurance of sterility and potential mold contamination.

    Product
    All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1735-2013·2013-07-31

    Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk

    Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was detected in the environment at the supplier, ARO Pistachio Inc.

    Product
    601041 HEALTHY HEART MIX 12/14 OZ TRAY, UPC 2052601041 601078 HEALTHY HEART MIX 12/8 OZ CLAMSHELL, UPC 2052601078 601078.03 HEALTHY HEART MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601078 601089 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 2052601089 601089.1 HEALTHY HEART…
    Category
    Food
    Distribution
    15 states
  • SevereNHTSA·13V332000·2013-07-31

    Blue Bird Recalls School Buses Due to Window Panel Adhesive Defect

    Blue Bird is recalling 2007-2014 All American and Vision school buses because missing window adhesive may cause panels to separate in a crash.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1777-2013·2013-07-31

    Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues

    Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.

    Product
    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2013·2013-07-31

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.

    Product
    Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1762-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding

    LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1734-2013·2013-07-31

    Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk

    Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Company.

    Product
    601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI…
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1727-2013·2013-07-31

    Amport Foods Recalls Vanilla Almond Granola Due to Metal Fragments

    American Importing Co. is voluntarily recalling specific packages of 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter.

    Product
    Vanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-820-2013·2013-07-31

    Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns

    Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.

    Product
    AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
    Category
    Drug
    Distribution
    Distributed nationwide