The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

45301–45325 of 50512

  • HighFDA (Food)·F-1786-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling specific lots of Kettle Brand Potato Chips, Sour Cream and Onion, because metal fragments were found in the raw material used for flavorings.

    Product
    Kettle Brand Potato Chips, Sour Cream and Onion, 12/8.5oz, item # 0711387001, UPC 0 84114 11393 1
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2083-2012·2012-08-01

    Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator

    Philips and Neusoft are recalling 15 NeuViz 16 CT scanners because a screw failure caused the oil accumulator to detach from the X-ray tube.

    Product
    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1803-2012·2012-08-01

    Meiko Pollock Fish Balls Recalled for Lack of HACCP Plan

    Meiko Foods is recalling Pollock Fish Balls because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Pollock Fish Balls , 2-10 lb bags. Product labeling reads in part:" MEIKO***POLLOCK FISH BALL S***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1800-2012·2012-08-01

    Chonita Foods Recalls Sonoran Rice for Undeclared Soy Protein

    Namias dba Chonita Foods is recalling 22 cases of Sonoran Rice due to undeclared hydrolyzed soy protein. The product was distributed only in Arizona.

    Product
    Sonoran Rice, 14 lbs (224 oz). Chonita Foods 847 E. 18th St. Tucson, AZ 85719.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1785-2012·2012-08-01

    Hidden Valley Salad Crispins Recalled for Potential Metal Fragment Contamination

    The Clorox Company is recalling Hidden Valley Salad Crispins Original Ranch due to potential metal fragment contamination in the buttermilk ingredient.

    Product
    Hidden Valley Salad Crispins Original Ranch; crisp mini-croutons, crunchy carrot bits and a blend of buttermilk and spices; Net Wt. 2.5 Oz. canister, 12 canisters per case; UPC 10071100 008347
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2068-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.

    Product
    VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2012·2012-08-01

    Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error

    Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.

    Product
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1787-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling New York Cheddar potato chips because metal fragments were found in the lactic acid used for flavorings.

    Product
    Kettle Brand Potato Chips, New York Cheddar; 1) 24/1.5oz, item # 0712278000, UPC 0 8114 11271 2; 2) 24/2 oz item # 0703320000 UPC 0 84114 03320 8; 3) 15/5 oz item # 0710863000, UPC 0 84114 0094 1; 4) 12/8.5 oz item #'s 0710813001 and 0710813500 (different numbers for…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2055-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.

    Product
    System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.

    Product
    VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1802-2012·2012-08-01

    Meiko Foods Recalls Tempura Due to Missing HACCP Plans

    Meiko Foods Co. Inc. is recalling 12 oz. Tempura products because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Tempura, 12 oz. Product labeling reads in part:" MEIKO***TEMPURA ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1808-2012·2012-08-01

    Hamchorom Recalls Korean Seasoned Oysters Due to Insanitary Conditions

    Hamchorom Inc. is recalling Korean Molluscan Shellfish (Seasoned Oysters) because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Korean Molluscan Shellfish (Seasoned Oysters) 250kg, 1000kg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2074-2012·2012-08-01

    BridgePoint Medical Recalls Stingray Catheters Due to Sterility Concerns

    BridgePoint Medical is voluntarily recalling Stingray Catheters because a faulty pouch seal may have compromised sterility assurance. No adverse clinical events have been reported.

    Product
    BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2012·2012-08-01

    Hospira LifeShield Burette Set Recalled Due to Sticking Float Valve

    Hospira is recalling 4,420 LifeShield Latex-Free 100 mL Burette Sets because the float valve may stick to the burette wall and fail to open or close properly.

    Product
    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2012·2012-08-01

    Westone Recalls Oto Ease Ear Lubricant Due to Microbial Contamination

    Westone Laboratories is recalling all Oto Ease ear lubricant products due to potential microbial contamination. The product is used to ease the insertion of hearing aids and earmolds.

    Product
    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1801-2012·2012-08-01

    Meiko Foods Recalls Cooked Shrimp Balls Due to HACCP Violations

    Meiko Foods Co. Inc. is recalling 8 oz. cooked shrimp balls because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Cooked Shrimp Balls, 8 oz. Product labeling reads in part:" TOM VIEN COOKED SHRIMP BALLS***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1788-2012·2012-08-01

    Kettle Brand Potato Chips Recalled for Metal Fragments in Flavorings

    Kettle Foods is recalling Krinkle Cut Cheddar and Sour Cream potato chips because metal fragments were found in the lactic acid used in the flavorings.

    Product
    Kettle Brand Potato Chips, Krinkle Cut Cheddar and Sour Cream; 1) 6/2 oz (caddy) item # 0711770000, UPC 0 8114 11715 1; 2) 24/2 oz item # 0711714000, UPC 0 84114 11715 1; 3) 15/5 oz item # 0711718000, UPC 0 84114 11719 9; 4) 12/8.5 oz item #'s 0711726001 and 0711726500…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2056-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 640 Advanced Perfusion System 1 units worldwide due to drive motor failures in the Sarns Centrifugal System.

    Product
    System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1806-2012·2012-08-01

    Hanmi Frozen Oyster Recall Due to Potential Norovirus Contamination

    Hanmi Incorporated is recalling 110 cases of frozen oysters distributed to Virginia, Maryland, and Pennsylvania due to potential norovirus contamination from fecal waste exposure.

    Product
    Frozen Oyster, Blocks, Wang Brand, 1 lb, packed in plastic bags, 24 bags/case, Item No.: 01356.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2089-2012·2012-08-01

    Stryker Recalls ABG II Modular Hip Stems for Corrosion Risk

    Stryker is recalling ABG II Modular Hip Stems to update instructions due to a reported rate of less than one percent for revisions associated with fretting and corrosion.

    Product
    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment verification when reagent lots are switched.

    Product
    VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2012·2012-08-01

    Stryker Recalls Rejuvenate Modular Hip Stems and Necks

    Stryker is recalling Rejuvenate Modular Hip System stems and necks due to a reported rate of less than one percent for revisions associated with fretting or corrosion.

    Product
    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1789-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling Kettle Brand Potato Chips, Cheddar Beer, because metal fragments were found in the raw lactic acid used in the flavorings.

    Product
    Kettle Brand Potato Chips, Cheddar Beer, item #0712374000, UPC 0 84114 12375 6.
    Category
    Food
    Distribution
    0 states
  • HighCPSC·12237·2012-07-31

    VAUDE Kenta Child Carriers Recalled for Fall Hazard

    Liberty Mountain is recalling VAUDE Kenta and Kenta Plus child carriers because a side strap seam can unravel, posing a fall hazard to children.

    Product
    Kenta and Kenta Plus child carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide