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.

17801–17825 of 29217

  • SevereFDA (Food)·F-1955-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood for Botulism Risk

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

    Product
    Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1960-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

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

    Product
    Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2612-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk

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

    Product
    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2618-2016·2016-08-31

    Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture

    Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1964-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

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

    Product
    Pacific Black Cod- Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1962-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling canned seafood, including razor clams, due to potential Clostridium botulinum contamination. The products were distributed in Oregon via mail order.

    Product
    Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1984-2016·2016-08-31

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

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

    Product
    OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1957-2016·2016-08-31

    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 Steelhead Salmon - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2611-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2662-2016·2016-08-31

    Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.

    Product
    Tecan Infinite 200. The SUNRISE 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-1963-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including razor clams, because they may be contaminated with Clostridium botulinum.

    Product
    Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2617-2016·2016-08-31

    Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2016·2016-08-31

    Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

    Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

    Product
    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2663-2016·2016-08-31

    Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating

    Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.

    Product
    Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1976-2016·2016-08-31

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

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

    Product
    OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1966-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including tuna, salmon, and black cod, due to potential Clostridium botulinum contamination.

    Product
    Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1983-2016·2016-08-31

    SM Fish Corp. Recalls Honey Mustard Herring for Listeria Risk

    SM Fish Corp. is recalling 336 containers of Ossie's Honey Mustard Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2665-2016·2016-08-31

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1961-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood for Botulism Risk

    Northwest Wild Products is recalling various canned seafood products due to potential Clostridium botulinum contamination. Consumers should check can codes and stop using affected items.

    Product
    Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2596-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-2622-2016·2016-08-31

    Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture

    Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2609-2016·2016-08-31

    Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect

    Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.

    Product
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V634000·2016-08-31

    Daimler Trucks Recalls 2014-2017 Models Due to Front Axle Hub Failure Risk

    Daimler Trucks North America is recalling specific 2014-2017 Freightliner and Western Star trucks because front axle hubs may fail, causing the wheel to separate from the axle.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4800, 5700, 108SD, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2016·2016-08-31

    Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture

    Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Neff DAgostino Percutaneous Access 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 (Food)·F-1954-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish and Razor Clams

    Northwest Wild Products is recalling canned fish and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.

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