The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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26276–26300 of 27686

  • CriticalFDA (Devices)·Z-1690-2013·2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1738-2013·2013-07-24

    St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems

    St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.

    Product
    Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1753-2013·2013-07-24

    Liebel-Flarsheim Hydra Vision DR 60/80 System Recalled for High Dosage

    Liebel-Flarsheim is recalling 12 Hydra Vision DR 60/80 systems because a service call found the maximum fluoroscopy dose was three times the safety limit.

    Product
    Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2013·2013-07-24

    St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers

    St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.

    Product
    Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back…
    Category
    Medical Device
    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 (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 (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
  • SevereFDA (Devices)·Z-1699-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1668-2013·2013-07-17

    Medtronic MiniMed Paradigm Insulin Infusion Sets Recalled for Malfunction Risk

    Medtronic MiniMed is recalling Paradigm insulin infusion sets because they may malfunction and deliver incorrect insulin volumes if exposed to fluids.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1667-2013·2013-07-17

    Bryan Medical Recalls Mislabeled Pediatric Tracheostomy Tubes

    Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm pediatric tracheostomy tubes because they were mislabeled as smaller infant tubes.

    Product
    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1685-2013·2013-07-17

    Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage

    Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.

    Product
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2013·2013-07-17

    Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material

    Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.

    Product
    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1669-2013·2013-07-17

    Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking

    Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.

    Product
    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633…
    Category
    Medical Device
    Distribution
    Distributed nationwide