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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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36276–36300 of 40449

  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1195-2014·2014-03-19

    Veridex Recalls CELLTRACKS Analyzer II Microscopes Due to Camera Failures

    Veridex, LLC is recalling 19 CELLTRACKS Analyzer II fluorescence microscopes because of reported camera failures. The devices are used for analyzing rare cells in biological fluids.

    Product
    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2014·2014-03-19

    Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error

    Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.

    Product
    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1156-2014·2014-03-19

    Mindray Recalls Panorama Central Station for Time Clock Data Lag

    Mindray is recalling 732 Panorama Central Stations because Full Disclosure data and event indicators may lag behind the system time clock.

    Product
    Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2014·2014-03-19

    Gyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits

    Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1190-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.

    Product
    G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1203-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Recall Due to Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.

    Product
    REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2014·2014-03-19

    Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch

    Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.

    Product
    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1180-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1152-2014·2014-03-19

    Leica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing

    Leica Biosystems is recalling 78 units of the ScanScope System software to clarify usage with specific RUO products.

    Product
    HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1191-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices…
    Category
    Medical Device
    Distribution
    40 states
  • LowFDA (Devices)·Z-1193-2014·2014-03-19

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.

    Product
    VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1166-2014·2014-03-19

    Steris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error

    Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.

    Product
    VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1143-2014·2014-03-12

    Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect

    Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.

    Product
    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2014·2014-03-12

    McKesson Anesthesia Care System Recalled for Data Mismatch

    McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.

    Product
    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1150-2014·2014-03-12

    Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk

    Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.

    Product
    Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1119-2014·2014-03-12

    Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns

    Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.

    Product
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1082-2014·2014-03-12

    Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors

    Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.

    Product
    Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2014·2014-03-12

    Elekta RT Desktop Software Recall for Calibration Input Errors

    Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.

    Product
    RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1084-2014·2014-03-12

    Elekta Agility Software Recall for Calibration Input Errors

    Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.

    Product
    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2014·2014-03-12

    Elekta Agility software recall for potential calibration input errors

    Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.

    Product
    Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2014·2014-03-12

    DeRoyal Circumcision Clamps Recalled for Manufacturing Defects

    DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.

    Product
    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1083-2014·2014-03-12

    Elekta Integrity Software Recalled for Calibration Input Errors

    Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.

    Product
    Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2014·2014-03-12

    GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure

    GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.

    Product
    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2014·2014-03-12

    Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure

    Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.

    Product
    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major…
    Category
    Medical Device
    Distribution
    Distributed nationwide