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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25476–25500 of 27686

  • HighFDA (Devices)·Z-0844-2014·2014-02-05

    Carestream Recalls Kodak DirectView DR 7500 Dual Detector Systems

    Carestream Health is recalling 164 Kodak DirectView DR 7500 Dual Detector Systems due to a possible patient image display error.

    Product
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2014·2014-02-05

    Synergetics Recalls 27ga Endo Illuminator Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 96 units of 27ga ONE-STEP Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2014·2014-02-05

    Synergetics Recalls 27ga Ophthalmic Chandelier Due to Faulty Sterile Seals

    Synergetics is recalling 24 units of 27ga ONE-STEP Awh/Tano Vivid Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2014·2014-02-05

    Synergetics Recalls 25ga Awh Vivid Chandelier Due to Faulty Seals

    Synergetics is recalling 108 units of 25ga Awh Vivid Chandeliers because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2014·2014-02-05

    Synergetics Recalls 23ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 43 units of 23ga Aspirating Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2014·2014-02-05

    ACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk

    ACUTE Innovations is recalling 176 units of the RibLoc U plus system because the implants may malfunction during surgical installation.

    Product
    The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0826-2014·2014-02-05

    Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach

    Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.

    Product
    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2014·2014-02-05

    Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors

    Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2014·2014-02-05

    Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2014·2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure

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

    Product
    Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Chow Illuminated Pick Due to Seal Failure

    Synergetics Inc. is recalling 44 units of Stiff 25ga Chow Illuminated Picks because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2014·2014-02-05

    Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure

    Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2014·2014-02-05

    BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.

    Product
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2014·2014-02-05

    Philips Brilliance CT Systems Recalled for Dose Calculation Issue

    Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.

    Product
    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0889-2014·2014-02-05

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

    Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2014·2014-02-05

    Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2014·2014-02-05

    BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.

    Product
    BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2014·2014-02-05

    Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise

    Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.

    Product
    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0854-2014·2014-02-05

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2014·2014-02-05

    Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction

    Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.

    Product
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0788-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0789-2014·2014-01-29

    Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions

    Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.

    Product
    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0812-2014·2014-01-29

    Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

    Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

    Product
    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0780-2014·2014-01-29

    Elekta XiO RTP System Recalled for Dose Calculation Error

    Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.

    Product
    XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional…
    Category
    Medical Device
    Distribution
    7 states