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.

43176–43200 of 50511

  • HighCPSC·13743·2013-07-24

    Big Lots Recalls Holiday Pathway Light Sets Due to Fire Hazard

    Big Lots is recalling about 29,500 Holiday Light Bulb Sets because the non-flame-retardant components pose a fire hazard. Consumers should stop using the lights and return them for a refund.

    Product
    Holiday Light Bulb Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2013·2013-07-24

    Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment

    Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.

    Product
    Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2013·2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling nanoFLEX and Afinity intraocular lenses because glass particles may be present in the storage vials.

    Product
    nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2013·2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling specific Afinity and nanoFLEX intraocular lenses because glass particles may be present in the storage vials.

    Product
    Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2013·2013-07-24

    SpineFrontier Recalls KRD1 PedFuse Rods Due to Fatigue Testing Failures

    SpineFrontier, Inc. is recalling KRD1 PedFuse Rods because one rod in each of two test constructs failed to meet fatigue requirements during dynamic compression testing.

    Product
    KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2013·2013-07-24

    Stryker TPS Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.

    Product
    Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1716-2013·2013-07-24

    Kenton's Cheese Company Recalls Bianco Brie-Style Cheese Due to E. coli

    Kenton's Cheese Company is recalling Bianco Brie-Style Cheese due to E. coli contamination. Consumers should return the product for a full refund.

    Product
    KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-798-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Foreign Substance Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1717-2013·2013-07-24

    Talenti Gelato Toasted Almond Recalled for Undeclared Pecans

    Talenti Gelato is recalling Toasted Almond flavor due to undeclared pecans. Consumers should check their freezers for the specific lot number.

    Product
    Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1729-2013·2013-07-24

    KooJoo Trading Company Recalls Unsterilized Safety Lancets

    KooJoo Trading Company is recalling specific lots of Odyssey safety lancets because they were not sterilized within the established validation dose range.

    Product
    Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1749-2013·2013-07-24

    Edwards Lifesciences Recalls Suction Wands Due to Plastic Particulate

    Edwards Lifesciences is recalling specific models of rigid suction wands because plastic particulate was found inside the sterile pouch and within the wand.

    Product
    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2013·2013-07-24

    Stryker CORE Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.

    Product
    CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-801-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Foreign Substance Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2013·2013-07-24

    Siemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect

    Siemens is recalling 23 AXIOM Artis zee/zeego angiographic x-ray systems because a tolerance problem in the generator power supply may cause the generator to fail.

    Product
    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2013·2013-07-24

    Hospira Recalls Symbiq IV Pump Sets Due to Air-in-Line Alarm Risk

    Hospira is recalling Symbiq IV pump sets because a defective ball valve may fail to seal, causing air-in-line alarms during fluid administration.

    Product
    LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.

    Product
    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2013·2013-07-24

    Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims

    Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.

    Product
    B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2013·2013-07-24

    Stryker RemB Electric Universal Driver Recalled for Unintended Activation

    Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.

    Product
    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V320000·2013-07-23

    Navistar Recalls IC School Buses for Flip Seat Pinch Hazard

    Navistar is recalling certain IC school buses equipped with C. E. White Inc. flip seats due to a risk of foot or toe pinch injuries.

    Product
    IC BUS — IC BUS, IC RESB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V321000·2013-07-23

    Compass Conversions Recalls 2003 Elite and 2007 Bloomer Horse Trailers

    Compass Conversions is recalling specific 2003 Elite and 2007 Bloomer horse trailers because power awning motor screws may shear, causing the awning to unfurl unexpectedly.

    Product
    BLOOMER — BLOOMER, ELITE HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide