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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25451–25475 of 27686

  • HighFDA (Devices)·Z-0894-2014·2014-02-05

    Synergetics Recalls 23ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 568 units of 23ga Wide Field Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2014·2014-02-05

    Synergetics Recalls 23ga Mid-Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 26 units of 23ga Mid-Field Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2014·2014-02-05

    Sorin S5/C5 Heart-Lung Machine Recalled for Pump Control Failures

    Sorin Group is recalling S5/C5 Heart-lung machines and CP5 centrifugal pump systems due to pump speed control knob failures that result in no response.

    Product
    S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2014·2014-02-05

    Sorin CP5 Centrifugal Pump System Recalled for Control Knob Failures

    Sorin Group is recalling 75 CP5 centrifugal pump systems due to reports of pump speed control knob failures that result in no response.

    Product
    CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2014·2014-02-05

    Siemens ACUSON SC2000 Ultrasound System Recalled for Loose User Interface

    Siemens Medical Solutions is recalling 843 ACUSON SC2000 ultrasound systems because the user interface assembly may become loose and fall off.

    Product
    ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,460 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2014·2014-02-05

    Philips Brilliance iCT Systems Recalled for Potential Image Artifacts

    Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.

    Product
    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2014·2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Laser Probes Due to Seal Failure

    Synergetics is recalling 72 sterile ophthalmic laser probes because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2014·2014-02-05

    Synergetics Recalls Two-Port Vitrectomy End Irrigators Due to Seal Failure

    Synergetics is recalling specific lots of Two-Port Vitrectomy End Irrigators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2014·2014-02-05

    Symmetry and CODMAN QUAD-LOCK Sterilization Containers Recalled for Sterile Barrier Failure

    Symmetry Medical/SSI is recalling QUAD-LOCK Sterilization Containers because they may not maintain an effective sterile barrier. The recall covers 2,991 units distributed worldwide.

    Product
    Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2014·2014-02-05

    Medtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue

    Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.

    Product
    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0875-2014·2014-02-05

    Synergetics Chandelier Infusion Cannula Recalled for Faulty Seals

    Synergetics Inc. is recalling Chandelier Infusion Cannulas due to faulty seals on the outer pouch, which could result in seal failure.

    Product
    Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2014·2014-02-05

    Synergetics Recalls Vivid Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the device.

    Product
    Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2014·2014-02-05

    Carestream DRX Evolution System Recalled for Unintended X-Ray Exposure

    Carestream Health Inc. is recalling four DRX Evolution System units because they allowed x-ray exposures without an image receptor, resulting in two exposures before an image was captured.

    Product
    Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2014·2014-02-05

    Synergetics Recalls 23ga Chandelier Infusion Cannulas Due to Seal Failure

    Synergetics Inc is recalling 240 units of 23ga Chandelier Infusion Cannulas because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

    Product
    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2014·2014-02-05

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic results.

    Product
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2014·2014-02-05

    Synergetics Recalls Sterile Ophthalmic Tubing Sets Due to Seal Failure Risk

    Synergetics Inc. is recalling 12 units of sterile ophthalmic tubing sets because faulty seals could fail, potentially compromising sterility.

    Product
    Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2014·2014-02-05

    Synergetics Recalls 23ga Chow Illuminated Pick Due to Faulty Seals

    Synergetics Inc. is recalling 38 units of 23ga Chow Illuminated Picks due to faulty seals that could compromise sterility.

    Product
    23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2014·2014-02-05

    Philips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors

    Philips Healthcare is recalling 50 InnerCool RTx Endovascular Systems because the main control board may display inaccurate low patient temperature readings and trigger false alarms.

    Product
    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Ophthalmic Devices Due to Seal Failure

    Synergetics Inc is recalling 36 units of 25ga Awh Chandelier ophthalmic devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2014·2014-02-05

    Accuray CyberKnife Robotic Radiosurgery System Recall for Mounting Assembly Issue

    Accuray is recalling 302 CyberKnife systems worldwide due to a potential safety issue where the Synchrony Boom Arm Mounting Assembly may detach.

    Product
    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2014·2014-02-05

    Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error

    Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.

    Product
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide