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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26501–26525 of 27686

  • HighFDA (Devices)·Z-1365-2013·2013-05-29

    Medical Information Technology Recalls Bi-Directional Communication Analyzer Interface

    Medical Information Technology, Inc. is recalling 56 MEDITECH Bi-Directional interactive Communication Analyzer Interface devices due to incorrect transmission of laboratory results.

    Product
    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1346-2013·2013-05-29

    Roche Recalls cobas 4800 Systems Due to Rare Channel Shift Errors

    Roche Molecular Systems is recalling 425 cobas 4800 systems because rare channel-shift errors may cause test results to be reported in the wrong channel.

    Product
    cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrodes

    Progressive Medical is recalling PTFE coated laparoscopic electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1274-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported death.

    Product
    Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.

    Product
    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2013·2013-05-22

    Integra Recalls BioMend Extend Membranes Due to Pyrogen Levels

    Integra LifeSciences is recalling BioMend Extend Absorbable Collagen Membranes because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2013·2013-05-22

    Integra Recalls Collagen Wound Dressings Due to Pyrogen Levels

    Integra LifeSciences is recalling 49,500 boxes of Colla Tape Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2013·2013-05-22

    ConMed Recalls PadPro Adult Radiotransparent Multifunction Electrodes Due to Connector Damage

    ConMed is recalling PadPro Adult Radiotransparent Multifunction Electrodes because damaged connector tooling may pinch lead wire filaments, potentially preventing the device from delivering appropriate energy or causing injury.

    Product
    PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2013·2013-05-22

    Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels

    Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels than permitted.

    Product
    Absorbable Collagen Sponge Provided As Intermediate to Another Company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2013·2013-05-22

    Integra Recalls INSTAT Hemostatic Agent Due to Pyrogen Levels

    Integra LifeSciences is recalling INSTAT absorbable hemostatic agent because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2013·2013-05-22

    Integra NeuraWrap Nerve Protector Recalled for Pyrogen Levels

    Integra LifeSciences is recalling 954 boxes of NeuraWrap Nerve Protector because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2013·2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 units of sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2013·2013-05-22

    Integra Recalls Helitene Absorbable Collagen Hemostatic Sponge

    Integra LifeSciences is recalling Helitene Absorbable Collagen Hemostatic Sponge because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2013·2013-05-22

    Integra Recalls BioMend Membranes Due to Pyrogen Levels

    Integra LifeSciences is recalling BioMend Absorbable Collagen Membranes because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2013·2013-05-22

    Integra Layershield Adhesion Barrier Matrix Recalled for Pyrogen Levels

    Integra LifeSciences is recalling 215 boxes of Layershield Adhesion Barrier Matrix because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2013·2013-05-22

    Integra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels

    Integra LifeSciences is recalling 812 boxes of OraMem Absorbable Collagen Membrane because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2013·2013-05-22

    Varian Segmented Cylinder Applicator Set Recalled for Potential Slippage During Treatment

    Varian Medical Systems is recalling 21 Segmented Cylinder Applicator Sets used for brachytherapy because they may slip during treatment, causing radiation to be delivered to areas outside the target.

    Product
    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2013·2013-05-22

    Edwards Lifesciences Recalls Proplege Coronary Sinus Catheters Due to Leakage

    Edwards Lifesciences is recalling Proplege Coronary Sinus Catheters, model PR9, because of confirmed blood leakage through the hemostasis valve in the kitted introducer.

    Product
    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2013·2013-05-22

    Integra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for…
    Category
    Medical Device
    Distribution
    Distributed nationwide