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.

17776–17800 of 29217

  • SevereFDA (Devices)·Z-2651-2016·2016-08-31

    Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

    Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

    Product
    Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1977-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Herring in Sourcream Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Herring in Sourcream because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1988-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Herring Clear due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1956-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products because they may be contaminated with Clostridium botulinum.

    Product
    Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1958-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including sardines, due to potential Clostridium botulinum contamination.

    Product
    Oregon Sardines - Mustard-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2616-2016·2016-08-31

    Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets

    Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.

    Product
    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2666-2016·2016-08-31

    Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

    Product
    Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1979-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Stiglitz Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Stiglitz Herring in New York and New Jersey because the manufacturing plant tested positive for Listeria monocytogenes.

    Product
    OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1952-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2613-2016·2016-08-31

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture

    Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.

    Product
    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2016·2016-08-31

    Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

    Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

    Product
    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2660-2016·2016-08-31

    Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2649-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond

    Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2650-2016·2016-08-31

    Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators

    Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.

    Product
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2016·2016-08-31

    Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2661-2016·2016-08-31

    Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1982-2016·2016-08-31

    SM Fish Corp. Recalls Dublin Herring for Listeria Risk

    SM Fish Corp. is recalling Ossie's Dublin Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1951-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1463-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.

    Product
    Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2664-2016·2016-08-31

    Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1953-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state